The HCPFive: Top News for Healthcare Providers from the Week of 03/02

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories included 5 new key decisions by the US Food and Drug Administration (FDA), including the first new stroke medication approved in nearly 30 years, a generic formulation of a popular anticoagulant receiving the green light, an expanded indication for an allergy-focused nasal spray, the first drug approved to treat a neurodegenerative retinal disease, and an expanded indication to treat edema in chronic kidney disease (CKD).

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of March 02, 2025—let’s jump in!

Interested in oncology news? Check out The OncFive, from our sister publication OncLive.

FDA Approves Tenecteplase (TNKase) for Acute Ischemic Stroke

The FDA approved Genentech’s tenecteplase (TNKase) for the treatment of adults with acute ischemic stroke (AIS), becoming the first stroke medicine approved by the regulatory agency in nearly 3 decades. Tenecteplase, a tissue plasminogen activator, clot-dissolving, thrombolytic medicine, is administered as a single, five-second intravenous (IV) bolus. Genentech announced plans to introduce a 25 mg vial configuration to support this approval.

FDA Approves First Generic of Rivaroxaban (Xarelto) for CAD, PAD

The first generic formulation of rivaroxaban (Xarelto) 2.5 mg tablets received approval to lower cardiovascular risk in adults with coronary artery disease (CAD) and thromboembolic risk in adults with peripheral artery disease (PAD). Anticoagulants, including rivaroxaban, are frequently prescribed in the US, with this generic approval directly impacting patients who rely on these medications.

FDA Approves 1 mg neffy Nasal Spray for Pediatric Anaphylaxis

ARS Pharmaceuticals announced the approval of epinephrine nasal spray 1 mg (neffy) for the treatment of type 1 allergic reactions, including anaphylaxis, in patients aged 4 years and older weighing 15 to less than 30 kg. This approval was awarded less than 7 months after the historic approval of neffy for adults and children who weigh 30 kg or more. Availability of the new 1 mg formulation is expected by May 2025.

FDA Approves Revakinagene Taroretcel (ENCELTO) for MacTel

Neurotech Pharmaceuticals received regulatory approval for revakinagene taroretcel-lwey (ENCELTO), formerly known as NT-501, to treat Macular Telangiectasia type 2 (MacTel). This green light marked the first and only FDA–approved treatment for MacTel, a neurodegenerative disease of the retina that can cause progressive and irreversible vision loss.

FDA Approves Furosemide Injection (Furoscix) for Edema in CKD

Regulators approved scPharmaceuticals’ supplemental New Drug Application (sNDA) for furosemide (Furoscix), expanding the drug’s indication to include the treatment of edema in patients with chronic kidney disease (CKD). Furosemide injection, 80 mg/10 mL for subcutaneous use is now approved to treat edema, including congestion, fluid overload, or hypervolemia, in adults with chronic heart failure or CKD, including nephrotic syndrome.