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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The U.S. Food and Drug Administration stunned the company with a Refusal to File letter regarding its New Drug Application (NDA) for multiple sclerosis treatment ozanimod.
Beijing-based Yisheng Biopharma Co. is celebrating this morning after its lead immunology treatment snagged a second Orphan Drug Designation from the U.S. Food and Drug Administration.
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) announced a string of approvals, as well as a couple rejections.
The U.S. Food and Drug Administration (FDA) has granted Shire’s Biologics License Application (BLA) for lanadelumab (SHP643) priority review.
Novartis is eying a possible 2019 launch for RTH258 (brolucizumab), an ophthalmology drug for the treatment of neovascular age-related macular degeneration.
The U.S. Food and Drug Administration (FDA) granted San Diego-based Evofem Biosciences Fast Track designation for Amphora vaginal gel to prevent urogenital chlamydia infection in women.
The U.S. Food and Drug Administration (FDA) approved AstraZeneca’s Imfinzi to treat patients with unresectable Stage III non-small cell lung cancer (NSCLC).
Despite the recent dismal news regarding Alzheimer’s drug development, the U.S. Food and Drug Administration (FDA) recently proposed new guidelines for developing drugs for the disease.