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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On April 23, the FDA’s arthritis advisory committee will take another look at Eli Lilly’s re-submission for their moderate-to-severe rheumatoid arthritis drug.
A U.S. Food and Drug Administration announced their decision to slap a clinical hold on Solid Biosciences Inc.’s experimental gene therapy treatment for Duchenne muscular dystrophy.
Hikma Pharmaceuticals generic version of Advair has hit a stumbling block with the FDA.
The U.S. Food and Drug Administration has approved Trogarzo (ibalizumab), the first HIV-1 inhibitor for patients with multi-drug resistant HIV-1.
There is a newly approved treatment for pediatric patients with major depressing episodes associated with bipolar disorder.
The U.S. Food and Drug Administration (FDA) approved the first-ever direct-to-consumer genetic test for cancer risk.
The U.S. Food and Drug Administration (FDA) expanded the dosing schedule for Bristol-Myers Squibb’s Opdivo (nivolumab).
Shares of Prometic Life Sciences Inc. jumped this morning after securing the U.S. Food and Drug Administration’s Rare Pediatric Disease Designation.
The U.S. Food and Drug Administration (FDA) issued new draft guidance for preclinical trials in Alzheimer’s.
Asthma patients may soon have a new treatment option.