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May 02, 2025
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This FDA News Month in Review provides a round-up of regulatory decisions from April 2025.
The FDA accepted the NDA for oral semaglutide 25 mg, a potentially revolutionary daily treatment for weight management and cardiovascular risk reduction.
April sees mixed outcomes in FDA approvals, with promising gene therapies advancing while others face setbacks, highlighting ongoing challenges in ocular treatments.
April 30, 2025
Johnson & Johnson announced the approval of FcRn blocker nipocalimab for adults and children > 12 years who are AChR or MuSK antibody positive.
FDA further postpones action date for elamipretide, a potential treatment for Barth syndrome, as discussions on labeling progress.
This announcement by Q32 Bio Inc. highlights the Fast Track designation by the FDA granted to bempikibart (ADX-914) for alopecia areata.
April 29, 2025
Upadacitinib joins tocilizumab as the second therapy to be approved for treating GCA.
This FDA approval makes pz-cel the first single application therapy to receive FDA approval for recessive dystrophic epidermolysis bullosa.
April 22, 2025
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.
