FDA
FDA inspectors warned UCSF radiopharmaceutical facility that losing environmental control could pose a serious hazard to patients.
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After Replimune’s advanced melanoma drug was rejected for a second time, CEO Sushil Patel slammed the FDA for failing to exercise regulatory flexibility, while other experts bemoaned the agency’s lack of consistency. With new safety guidelines for gene editing therapies, the FDA has taken a first step toward fixing both problems.
BioSpace looks back at 2025 and where the FDA is going in 2026.
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
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Janssen got a little love from the FDA on Wednesday.
Teva and Mylan are looking over their shoulders this morning after the FDA gave Novartis and Momenta the green light for their Copaxone copycat drug.
The FDA approved Vertex’s Symdeko for cystic fibrosis in patients ages 12 and older with two copies of the F508del mutation.
The FDA approved Gilead’s triple combination treatment for HIV, Biktarvy.
Topcon’s touted its system as being able to quickly penetrate ocular tissues without being obscured by hemorrhage or media opacities.
Ra Medical only has five full-time salespeople on staff, but expects that to grow to 20 to 25 people later this year.
The company believes the Translarna data is compelling and pointed to the success the drug is having in Europe.
2017 was the second-best year for FDA approvals since 1996.
The FDA approved Merck’s and Pfizer’s Steglatro, a SGLT2-inhibitor, that will square off against established drugs in the market.
The FDA broke new ground today with a first-of-its-kind therapy for eye disease.