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April 22, 2025
Article
Orchestra BioMed’s Breakthrough Device designation could apply to nearly 8 million patients with uncontrolled hypertension and increased cardiovascular risk
April 18, 2025
The FDA identified no issues with the safety or efficacy of aflibercept 8 mg in any of its already approved dosing regimens or indications.
Dupilumab's approval marks the first new, targeted therapy for CSU in more than a decade and is the 7th indication for a disease with underlying type 2 inflammation.
Label updates simplify twice-yearly echo monitoring for eligible patients in the maintenance phase and expand eligibility with reduced contraindications.
April 17, 2025
If approved, aflibercept 8 mg would mark the first RVO treatment indicated for up to every 8-week dosing, halving the injection frequency of other anti-VEGF options.
April 16, 2025
The FDA cleared the expanded indication for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome.
April 15, 2025
The interchangeable designation was granted to CT-P17, a biosimilar to adalimumab (Humira), for inflammatory diseases such as psoriasis.
A first-of-its-kind medication developed by Atsena Therapeutics, ATSN-201 has already received three other FDA designations.
April 14, 2025
The new tablet formulation of maralixibat for the treatment of cholestatic pruritus in patients with ALGS and PFIC is expected to be available in June.
April 11, 2025
VERVE-102 is targeting the reduction of LDL-C levels among individuals with hyperlipidemia and high lifetime cardiovascular risk.
