Stealth CEO Reenie McCarthy said the FDA made an informed, science-based decision to approve Forzinity, recognizing both the ...
The head of the U.S. Food and Drug Administration’s drug division, Dr. George F. Tidmarsh, resigned on November 2, 2025, one ...
The FDA declined to consider elamipretide for full approval in 2021 and rejected the company's application in May of 2025 ...
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FDA Approves IV Antibiotic for Complicated UTIs
The FDA approved an intravenous (IV) formulation of fosfomycin (Contepo) to treat adults with complicated urinary tract ...
Ironwood Pharmaceuticals (IRWD) stock gains as the FDA approves a label expansion for the company's AbbVie (ABBV)-partnered ...
Treatments for asthma, chronic rhinosinusitis with nasal polyps, dyslipidemia, Cushing syndrome, gonorrhea, HSCT-associated thrombotic microangiopathy, marginal zone lymphoma, motion sickness, ...
The FDA has approved Kygevvi (doxecitine and doxribtimine) for the treatment of TK2d in adults and pediatric patients with an age of symptom onset on or before 12 years.
The agency might dissuade patients from participating in a crucial part of our research-and-development system.
According to reporting from Reuters, reviewers at the agency pointed to an inability to differentiate from placebo to justify rejecting the drug, but an FDA office director approved the drug anyway.
Dr George Tidmarsh, who joined the FDA in July, stepped down Sunday, The New York Times reported. His resignation came just days after he was placed on administrative leave while federal officials ...
UCB has announced FDA’s approval of Kygevvi (doxecitine and doxribtimine) for the treatment of adults and pediatric patients ...
India's top drug regulator cited insufficient evidence of efficacy in the two studies conducted by Serum Institute and ICMR.
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