Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

Image Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA)

 has approved zilurgisertib (Atebrioz) tablets to reduce the volume of total new heterotopic ossification (HO) in adults and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva (FOP).

The FDA approved zilurgisertib (Atebrioz), an oral ALK2 inhibitor, for FOP in patients aged 12 years and older, making it the third approved FOP therapy.

In PROGRESS, total new HO volume fell by a mean of 3.2 cm³ with zilurgisertib vs a 24.6 cm³ increase with placebo at week 24.

The prespecified primary endpoint, proportion of patients with new HO lesions, showed an 81% relative reduction but did not reach statistical significance (P = .0986).

No AEs led to discontinuation or dose reduction; the label warns of embryo-fetal toxicity.

Pediatric cohorts down to age 2 years are ongoing.

The approval, announced September 25, 2026, is based on the randomized, double-blind, placebo-controlled phase 2 PROGRESS trial. The recommended starting dosage is 100 mg orally once daily, with or without food.

Zilurgisertib, an oral small-molecule activin receptor-like kinase 2 (ALK2) inhibitor developed by Mirum Pharmaceuticals under license from Incyte, is the third FDA-approved therapy for FOP. It follows the 2023 approval of palovarotene (Sohonos), an oral retinoic acid receptor gamma agonist, and the August 2026 approval of garetosmab-grts (Pasatru), an intravenous activin A antibody dosed every 4 weeks. Unlike garetosmab, whose label is limited to adults, zilurgisertib is indicated for patients as young as 12 years.

Cohort 1 of PROGRESS randomized 63 patients aged 12 years and older 1:1 to zilurgisertib 100 mg (n = 32) or placebo (n = 31) once daily for 24 weeks. A single-arm, open-label extension followed, during which all patients received zilurgisertib 100 mg daily. Mean age at baseline was approximately 21 years, and treatment groups were generally balanced, according to Mirum and Incyte.

The FDA based its efficacy assessment on change from baseline in the volume of total new HO vs placebo during the double-blind period, measured by whole-body CT. At week 24, patients receiving zilurgisertib had a mean decrease of 3.2 cm

, compared with a mean increase of 24.6 cm

 in the placebo group (nominal P = .004).

The prespecified primary endpoint of PROGRESS was the proportion of patients developing new HO lesions at week 24. One patient (3.1%) in the zilurgisertib arm developed new lesions vs five patients (16.7%) in the placebo arm, an 81% relative reduction (P = .0986). This difference did not reach statistical significance.

Zilurgisertib secondary outcomes and safety in FOP

Mean volume of new HO lesions at week 24 was 0.003 cm

 with placebo, a reduction exceeding 99% (nominal P < .0001). Annualized new flares averaged 2.34 with zilurgisertib vs 4.55 with placebo.

Through week 48, no new HO lesions were observed among 61 patients with available whole-body CT data, including patients crossing over from placebo at week 24. From week 24 to week 48, total HO lesion volume continued to decline in the continuous zilurgisertib group (mean change, −6.37 cm

) and the crossover group (mean change, −5.32 cm

According to Mirum and Incyte, most adverse events (AEs) during the placebo-controlled period were mild or moderate, and no AEs led to discontinuation or dose reduction. The most common AEs with zilurgisertib were FOP flare-up or FOP-related pain (25%), headache (21.9%), upper respiratory tract infection (21.9%), arthralgia (18.8%), epistaxis (12.5%), and nausea (12.5%). Serious AEs and grade 3 or higher AEs occurred at low rates in both arms.

The label carries a warning for embryo-fetal toxicity based on animal data. Patients of reproductive potential should use effective contraception and discontinue zilurgisertib immediately if pregnancy occurs. The label also restricts coadministration with certain concomitant medications.

Joanne Quan, MD, chief medical officer at Mirum Pharmaceuticals, said at the time of the PROGRESS data release, "People living with FOP and their families urgently need additional treatment options."² The pivotal Cohort 1 results were presented as a late-breaking abstract at ENDO 2026 in June.²

Additional PROGRESS cohorts are evaluating zilurgisertib in children aged 6 to younger than 12 years and in children aged 2 to younger than 12 years. The FDA granted the application fast track, priority review, and orphan drug designations.

US Food and Drug Administration. FDA approves third treatment for fibrodysplasia ossificans progressiva. Published September 25, 2026. Accessed September 25, 2026. 

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-third-treatment-fibrodysplasia-ossificans-progressiva

Mirum Pharmaceuticals, Incyte. Mirum Pharmaceuticals and Incyte announce positive pivotal phase 2 results from PROGRESS study of zilurgisertib in fibrodysplasia ossificans progressiva. Published June 14, 2026. Accessed September 25, 2026. 

https://ir.mirumpharma.com/news/news-details/2026/Mirum-Pharmaceuticals-and-Incyte-Announce-Positive-Pivotal-Phase-2-Results-from-PROGRESS-Study-of-Zilurgisertib-in-Fibrodysplasia-Ossificans-Progressiva/default.aspx

US Food and Drug Administration. FDA approves first treatment for fibrodysplasia ossificans progressiva. Published August 16, 2023. Accessed September 25, 2026. 

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-fibrodysplasia-ossificans-progressiva

US Food and Drug Administration. FDA approves second treatment for fibrodysplasia ossificans progressiva. Published August 19, 2026. Accessed September 25, 2026. 

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-second-treatment-fibrodysplasia-ossificans-progressiva

Articles

FDA approval of zilurgisertib (Atebrioz), an oral ALK2 inhibitor, expands the FOP armamentarium as the third available therapy and the first newly approved option down to age 12 since palovarotene. Authorization is supported by phase 2 PROGRESS data showing significant reduction in total new heterotopic ossification volume by whole-body CT at 24 weeks versus placebo, despite a nonsignificant primary endpoint on the proportion developing new lesions. Safety was largely mild-to-moderate, with embryo-fetal toxicity warnings and drug–drug interaction restrictions.

The FDA approved once-daily oral zilurgisertib for FOP in patients aged 12 years and older after the phase 2 PROGRESS trial showed reduced new heterotopic ossification vs placebo.

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The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

This page also hosts content previously published by EndocrinologyNetwork. 


FDA News

Zilurgisertib Receives FDA Approval for FOP in Patients 12 and Older

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Once-weekly basal insulin options for adults with 

 have doubled in 2026, with the FDA approval of insulin efsitora alfa-gobe (Onswik) following the March clearance of insulin icodec-abae (Awiqli). Efsitora pairs a fixed weekly regimen with two high-concentration pen formulations built for a wide dosing range.

, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, reviewed the September 24, 2026, approval of Eli Lilly's efsitora, its supporting phase 3 evidence, and practical considerations for prescribing.

FDA Approves a Second Once-Weekly Basal Insulin: What the QWINT Data Show

Watch the full episode discussing the FDA’s approval of efsitora alfa-gobe

The approval rests on four phase 3 QWINT trials comparing efsitora with daily insulin glargine U-100 or insulin degludec U-100. Efsitora met the primary endpoint of noninferior A1C reduction in each study, with reductions ranging from 0.81 to 1.26 percentage points. Because insulin trials target comparability rather than superiority, these results support substituting efsitora for daily basal insulin without sacrificing glycemic control.

Hypoglycemia data offer a clearer point of differentiation. Rates of clinically significant or severe hypoglycemia were similar to daily comparators across the program, but insulin-naive participants in QWINT-1 experienced 43% fewer events than those receiving glargine. A flatter steady-state profile may account for the gap, since glargine varies between individuals and may not provide full 24-hour coverage in every patient.

Titration strategy likely contributes as well, and optimal initiation and titration approaches are still being refined, as occurred with icodec. The indication excludes type 1 diabetes, where trials showed higher hypoglycemia rates, although clinicians can envision future use cases in this population.

Dosing logistics differ meaningfully from icodec, a U-700 formulation dosed in 10-unit increments. The efsitora U-500 pen delivers up to 400 units per injection in five-unit increments, while the U-1000 pen delivers up to 800 units in 10-unit increments for patients with higher requirements. Dividing weekly doses by seven gives the daily equivalent, so a 400-unit injection corresponds to roughly 57 units per day.

With two weekly basal insulins now available, clinicians face a new learning curve around pen concentrations, dose increments, and quantities per prescription. Efsitora's hypoglycemia profile in insulin-naive patients may make it an appealing option for basal insulin initiation, where reducing injection burden could help address delays in starting therapy.

Editors’ Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.

Rosenstock J, Bailey T, Connery L, et al. Weekly fixed-dose insulin efsitora in type 2 diabetes without previous insulin therapy. 

Philis-Tsimikas A, Bergenstal RM, Bailey TS, et al. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial. 

Blevins T, Dahl D, Pérez Manghi FC, et al. Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial. 

Videos

In this segment from the latest episode of Diabetes Dialogue, Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the FDA's approval of a new basal insulin for T2D.

Type 2 Diabetes

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

, a rare kidney disease usually diagnosed in early childhood.¹ Genentech said it is the first FDA approved treatment for INS in 70 years.

The approval covers adult and pediatric patients aged ≥2 years with frequently relapsing or steroid dependent childhood onset INS who are in complete remission, with the goal of reducing the risk of relapse. It is based on the phase 3 INShore trial. In that trial, 95% of patients treated with obinutuzumab had no relapses after week 8 and were in complete remission at week 52, compared with 73% of those receiving mycophenolate mofetil (MMF).¹

"Gazyva is the first FDA-approved treatment option for idiopathic nephrotic syndrome in 70 years, introducing a substantial advancement for children and families who have long relied on steroids and faced high rates of relapse," Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech, said in a statement.¹

INShore Trial Design: Obinutuzumab vs MMF in Steroid Dependent INS

INShore was a randomized, open label phase 3 trial. It included 85 children and young adults aged 2 to 25 years who were in clinical remission and had frequently relapsing or steroid dependent nephrotic syndrome.² Patients were randomized to obinutuzumab or MMF.

Obinutuzumab is a CD20 directed monoclonal antibody that targets B cells. It was previously approved for chronic lymphocytic leukemia, follicular lymphoma, and active lupus nephritis.²

Obinutuzumab Achieves 95.5% Sustained Complete Remission at Week 52

Previously reported INShore data showed sustained complete remission at week 52 in 95.5% of patients treated with obinutuzumab vs 73.2% of those receiving MMF. The adjusted difference was 23.39% (95% CI, 6.85 to 38.90; 

According to Genentech, key secondary endpoints also favored obinutuzumab over MMF:¹

The company reported no new safety signals.

Obinutuzumab Safety in INS: Infections and Infusion Reactions

The most common adverse events in childhood onset INS were:¹

Patients taking obinutuzumab may be at greater risk of severe infections than those taking MMF. Patients with an active infection should not be treated.¹

The prescribing information includes warnings for hepatitis B virus (HBV) reactivation and progressive multifocal leukoencephalopathy (PML). Patients must be screened for HBV before treatment and monitored during and after treatment. Severe neutropenia can develop during or after treatment, and some cases last >1 month.¹

Live vaccines should not be given during treatment. In childhood onset INS, live vaccines should be received ≥28 days before starting obinutuzumab.¹

INS Relapse Rates Exceed 70% With Steroid Based Treatment

INS is the most common form of primary glomerular disease in children. It is marked by unpredictable relapses that cause:¹

Increased susceptibility to infections and clotting

Anxiety, depression, and reduced self esteem

Steroids remain the mainstay of treatment. However, relapse rates are >70%, and steroid side effects can limit long term use.¹

"For too long, patients living with INS have had to endure unpredictable relapses, prolonged steroid use, and the constant threat of disease progression," Andi Callaway, founder and president of The Nephrotic Syndrome Foundation, said in a statement.¹ "This approval of Gazyva marks a shift that enables patients and families facing this debilitating disease to raise expectations for care and look ahead with optimism for a brighter future."

Obinutuzumab Pipeline: Membranous Nephropathy and SLE Decisions Ahead

This is the second FDA approval of obinutuzumab in immune mediated disease, following its approval in adult lupus nephritis in 2025.¹ The FDA granted Breakthrough Therapy Designation for both conditions and granted Priority Review for INS.

Obinutuzumab is also under FDA review for two more indications:¹

 based on the phase 3 MAJESTY trial, with a decision expected by November 2026³

 based on the phase 3 ALLEGORY trial, with a decision expected by December 2026⁴

It is also being investigated in pediatric lupus nephritis.¹

Genentech. FDA approves Gazyva for idiopathic nephrotic syndrome in patients aged 2 and older. Published September 25, 2026. 

https://www.gene.com/media/statements/ps_092526

Obinutuzumab achieves 95.5% remission in INS, may shift steroid-sparing treatment strategies. HCPLive. Published June 25, 2026. 

https://www.hcplive.com/view/obinutuzumab-95-remission-ins-steroid-sparing-treatment-strategies

FDA grants priority review to Genentech's Gazyva for adults with primary membranous nephropathy. Genentech. Published July 14, 2026. 

https://www.gene.com/media/press-releases/15121/2026-07-14/fda-grants-priority-review-to-genentechs

FDA accepts application for Genentech's Gazyva for the treatment of the most common form of lupus. Genentech. Published April 20, 2026. 

https://www.gene.com/media/press-releases/15107/2026-04-20/fda-accepts-application-for-genentechs-g

FDA approved obinutuzumab for frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome in patients aged ≥2 years who are in complete remission, aiming to reduce relapse risk. Approval is supported by the phase 3, randomized open-label INShore trial comparing obinutuzumab with mycophenolate mofetil in 2–25-year-olds, demonstrating higher sustained complete remission at week 52 (95.5% vs 73.2%) and improved relapse-related secondary endpoints. Safety was consistent, with infections and infusion reactions prominent and warnings for HBV reactivation, PML, and neutropenia.

Approval covers patients aged ≥2 years with frequently relapsing or steroid dependent disease in complete remission.

Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

FDA Approves Obinutuzumab (Gazyva) for Idiopathic Nephrotic Syndrome

Ari Cohen, MD, MBA, is director of the Transplant Institute at Ochsner Health. 

Ochsner Health has performed its 10,000th organ transplant, a milestone that spans 

 transplantation. The program has also completed 40 robotic-assisted kidney transplants and is using organ preservation machines to evaluate donor organs once considered not transplantable.

"Reaching 10,000 transplants is really more than just a number," Ari Cohen, MD, MBA, director of the Transplant Institute at Ochsner Health, said in an interview with 

. "It reflects decades of experience that started back in 1970, when we performed the first heart transplant in the Gulf South, and it's led us to develop a comprehensive, high-volume transplant program."

Robotics and Organ Preservation in Transplant, With Ari Cohen, MD, MBA

Multidisciplinary Care Behind 10,000 Organ Transplants

"I'm a surgeon, but to me, the success doesn't just lie with our surgical expertise," Cohen said. "It really relies on multidisciplinary care, ongoing innovation, coordinated access for our patients, the trust of our patients, and the trust that we pass on to our donor families."

He described the milestone in terms of what it means for patients: the opportunity to return home to their families healthy and go on to lead the lives they're supposed to live.

Robotic-Assisted Kidney Transplant Broadens Candidacy

"We've learned that robotic-assisted transplant surgery really has a role within the transplant arena, and it's appropriate for a lot of our patients," Cohen said.

Across the program's 40 robotic-assisted kidney transplants, he pointed to reduced recovery time and increased surgical precision. The approach has also expanded who can be considered for surgery.

"It has also allowed us to broaden the effort, so that people we previously thought were not candidates for transplant surgery can have it done robotically, get a successful transplant, and continue on with their lives," he said.

Organ Preservation Machines Expand the Donor Pool

"Some of the more recent machines that have become available for transplant are commonly called organ pumping machines, but we really view them as having a role in the rehabilitation of some of these organs," Cohen said.

According to Cohen, the machines provide more information about an organ's viability, including whether it is usable and whether it would result in a successful transplant.

"These machines have become critical for our decisions about whether an organ is suitable to transplant, and they've helped us expand the donor pool, because an organ previously thought of as not transplantable can become transplantable after spending some time on one of these machines," he said.

Ochsner Health. Ochsner Transplant Institute performs 10,000th transplant surgery. News release. August 12, 2026. Accessed September 25, 2026. 

https://news.ochsner.org/news-releases/ochsner-transplant-institute-performs-10-000th-transplant-surgery/

Ochsner Health. Ochsner Transplant Institute. Accessed September 25, 2026. 

https://www.ochsner.org/services/organ-transplants/

An Ochsner transplant surgeon discusses 10,000 transplants and how new tools are expanding who can receive an organ. 

Chronic Kidney Disease

Hepatology

Strategic Alliance Partnership

Sarah Norman, MPP, executive director of BrainFutures.

The US Food & Drug Administration (FDA) held a public hearing on September 14, 2026, seeking testimony on provider training, patient safety, access, and data standardization for the potential therapeutic use of psychedelics.¹

The hearing arrived with late-stage candidates nearing regulatory review, including COMP360, a synthetic psilocybin for treatment-resistant depression, and DT120, a lysergide formulation with 3 positive phase 3 readouts in 

 and generalized anxiety disorders.²˒³ Compass anticipates launching COMP360 in the first half of 2027, pending FDA approval and Drug Enforcement Administration rescheduling, leaving little lead time for the psychiatrists, nurses, and therapists who would screen, dose, and monitor patients.²

In a NORC survey of 418 academic leaders released in December 2024, spanning counseling, social work, nursing, psychology, and other disciplines, 79% agreed psychedelics show promise for treating psychiatric disorders.

 Yet 92% said their programs lacked sufficient faculty to teach advanced coursework in psychedelic-assisted therapy, only 3% had built therapy-specific program tracks, and none offered a certificate.

In the following Q&A, Sarah Norman, MPP, executive director of BrainFutures, a national nonprofit advancing evidence-based innovations in brain health, discusses the hearing's takeaways, where credentialing and reimbursement stand, how psychedelic care may differ from esketamine and TMS, and why readiness cannot wait. She says there is no question that psychedelic therapies will become available in clinical settings. It is more of a matter of when and how we prepare before an approval.

Q&A: What the FDA Psychedelic Hearing Means for Psychiatrists

For clinicians who missed the FDA hearing on psychedelics, what were the top highlights?

 On September 14, the FDA held a 4-hour public hearing on the potential therapeutic use of psychedelics. About 80 speakers were selected at random from more than 200 requests. SAMHSA, NIDA, and the VA's Veterans Health Administration were on a listening panel alongside the FDA.

These are signals that implementation is a cross-agency issue, and this was not just a focus on drug approvals. Written comments are open until October 5 on regulations.gov, and folks who are interested in submitting comments should consider doing so.

We will be submitting written comments as well, likely in a joint response with other mental health organizations. Implementing psychedelics in a safe, ethical, and affordable way is going to require multiple organizations to come to the table to ensure we are truly ready for a new mental health and behavioral health intervention.

Our core message is that system readiness is critical. It appears the FDA is on the eve of approval of 1 or more psychedelic therapies, and therefore critical attention is needed to workforce development, training, and care models, as well as access, coverage, and reimbursement.

What gaps in provider training came up most often in the testimony, and how do they affect patient safety?

 BrainFutures is spending a lot of attention and focus to address gaps in provider training and patient safety. With psychedelics in particular, there are specific considerations around informed consent, given the fact that folks may be in an altered state of consciousness.

What we're trying to do is develop a framework that will build on top of current training and expertise. We completed an analysis of that and are now in a working group phase to ensure the evidence base, clinical expertise, and consumer voice are represented in developing a competency-based framework.

There was very consistent consensus around the notion that we need to think about provider training within a competency-based framework. That came out very loud and clear from the 80 speakers at the FDA forum.

Where does licensure and credentialing for psychedelic-assisted therapy stand today, and what needs to change before broader clinical adoption?

 There is emerging consensus, again, that this is not a specific type of provider. Rather, it builds on existing licensed professionals, such as psychiatrists, social workers, nurses, and peer specialists, with added competency-based training.

When you think about developing a care team that might deliver it, it's going to require bringing to the table the expertise of diverse professionals, including medical doctors, but also nurses, social workers, peer specialists, and others. Social workers, licensed clinical professional counselors, all those folks need to come to the table to develop and deliver this in a safe and ethical way.

If the FDA approves a psychedelic drug this year, how soon could psychiatrists expect credentialing and reimbursement pathways?

 It does appear the FDA is on the horizon of approving psychedelics pretty soon. After that happens, there will be a review and rescheduling [by the DEA], a process that can take approximately 90 days, and from there, additional steps are needed.

I think the critical point to take away is we're on the eve of approval, and we need to start to get ready today. We should have been getting ready previously.

What should psychiatrists treating MDD understand about how psychedelic care delivery might differ from ketamine, esketamine, or TMS?

 We can expect a new set of interventions for a variety of mental health indications: TRD, PTSD, and generalized anxiety disorder. For that set of diagnoses, the range of options patients, doctors, and psychiatrists can consider will probably shift pretty significantly.

I would also like to acknowledge that after these medications are approved for those indications, there are active investigations and clinical trials related to substance use disorder and other indications. It feels like a wave rolling out, with a lot of change going on.

I think it is likely psychedelics will not necessarily be the first line of treatment, as we've seen with Spravato and TMS, which have often been a secondary treatment option. That being said, they add a set of different interventions that can work when existing treatments are failing, so there's a different way to think through the algorithm. The evidence base is still developing around which treatments benefit whom, and when, so some of it is going to have to be informed by real-world evidence generation.

It's actually exciting that agencies like ARPA-H are investigating that. Which intervention works best for which patient? Is it going to be an SSRI, TMS, accelerated TMS, or a psychedelic, and which one?

We'll have increasing evidence we can use to refine the treatment algorithm. But for now, we do have some evidence we can use to tailor treatment, and an understanding of which interventions have what types of side effects.

What did the BrainFutures/NORC research find about academic capacity to train this workforce, and how large is the gap?

 In 2024, we worked with NORC to survey 400 academic leaders, and we released the findings in December 2024. It was a very rigorously done survey of academic leaders in disciplines such as social work, counseling, nursing, and psychology. Of those, 79% agreed that psychedelics show promise for treating psychiatric disorders.

Of respondents, 30% reported offering some sort of psychedelic therapy education, but only 5% include psychedelic therapy content in required graduate-level courses. It laid the groundwork, but there's a lot of work to do to ensure psychedelic therapy is addressed as we're training new clinicians.

The other thing that's absolutely critical is, while it's important to work with our new clinicians in training, the vast majority of therapeutic interventions today are provided by existing clinicians. That's why we are developing this competency-based framework, which can allow for scaling, train-the-trainer models, and other systematic ways to train existing clinicians.

For clinicians skeptical of psychedelic therapies, what is the strongest case for building readiness now rather than waiting for approval?

 It’s very clear an approval is going to happen very shortly. If [a clinician] waits until after approval, [they are] not going to be ready to answer the questions that come to the fore. The uncertainty of the timeline should not preclude us from starting the work.

I regularly present at national mental health organizations' conferences, and I am increasingly getting questions from psychiatrists whose patients are asking them about psychedelics today. They want to know how to answer that question today, because they know this is where patients are looking for additional or newer treatments to support them.

Given that approval is on the edge right now, workforce development isn't an overnight thing. If we wait a year until approval, we're really not going to be able to provide this service until years later.

The National Academy of Sciences did a famous report looking at the gap between a new treatment and it reaching patients, and it was 17 years. The reason is because people don't get ready.

A Call for System Readiness at the FDA Hearing on Sept. 14. BrainFutures. Published September 15, 2026. Accessed September 25, 2026. 

https://www.brainfutures.org/blog/fdahearing/

Dunlop B. COMP360 Psilocybin for TRD: What to Know Before a Possible 2027 Launch. HCPLive. Published July 17, 2026. Accessed September 25, 2026. 

https://www.hcplive.com/view/comp360-psilocybin-trd-what-know-before-2027-launch

Derman C. Voyage: DT120 ODT Reduces Anxiety in Phase 3 GAD Trial. HCPLive. Published August 12, 2026. Accessed September 2025, 2026. 

https://www.hcplive.com/view/dt120-odt-primary-endpoint--voyage-phase-3-gad-trial

New NORC/BrainFutures study finds psychedelics in healthcare practitioner training is growing. BrainFutures. Published December 11, 2024. Accessed September 25, 2026. 

https://www.brainfutures.org/blog/new-norc-brainfutures-study-finds-psychedelics-in-healthcare-practitioner-training-is-growing/

The FDA’s September 14, 2026 public hearing signaled imminent commercialization planning for psychedelic-assisted therapies, emphasizing cross-agency coordination (FDA, SAMHSA, NIDA, VA) beyond drug approval. Late-stage assets such as COMP360 and DT120 intensify urgency, with possible 2027 launch timelines constrained by DEA rescheduling and limited clinician lead time. Consensus testimony prioritized competency-based training, robust informed consent protections for altered states, and team-based delivery models spanning psychiatry, nursing, social work, and peer specialists. Academic training capacity remains insufficient, making scalable upskilling essential to avoid prolonged implementation delays.

As the FDA weighs its first psychedelic approval, Sarah Norman, MPP, says training, credentialing, and reimbursement are lagging while patients are already asking.

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

PTSD

What The FDA Psychedelic Hearing Means for Psychiatrists 

In this segment from the latest episode of Diabetes Dialogue, Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss UACR screening for patients with CKD and T1D.

Type 1 Diabetes

UACR Screening and Finerenone Safety in Diabetic CKD

Pranav Garimella, MBBS, MPH, is chief medical officer of the American Kidney Fund.

Pranav Garimella discusses what a potential USPSTF kidney screening recommendation could mean for high-risk adults and primary care.

The Case for Routine Kidney Screening, With Pranav Garimella, MBBS, MPH

A multicenter registry investigator details real-world AFib incidence with mavacamten and compares it against pivotal trial findings.

Video Series

Understanding EXPLORER-HCM and VALOR-HCM AFib Signals

Clinicians weigh how their real-world obstructive HCM patients compare with EXPLORER-HCM and VALOR-HCM trial cohorts.

Comparing Clinical Experience to Trials in oHCM Patients

Killian Lozach, MBA, business development and alliance management lead, Woodberry Associates.

Lozach outlines how the Corticosteroid Stewardship Alliance plans to bring clinician data and adverse event costs to payers and lawmakers.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Moving Corticosteroid Stewardship into Policy, With Killian Lozach, MBA

Podcasts

Andrea Murina, MD, weighs whether she would recommend medicine to her own children amid AI, physician burnout, and evolving residency training standards.

Latest News

Zilurgisertib Receives FDA Approval for FOP in Patients 12 and Older

FDA Approves a Second Once-Weekly Basal Insulin: What the QWINT Data Show

FDA Approves Obinutuzumab (Gazyva) for Idiopathic Nephrotic Syndrome

Robotics and Organ Preservation in Transplant, With Ari Cohen, MD, MBA

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