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U.S. FDA
Fierce Pharma
FDA's response letter salvo sheds light on drug refusal process
The FDA's response letter salvo offers an in-depth view into the high-stakes discussions that decide whether a medicine will ever make it to market.
James Waldron
,
Fraiser Kansteiner
Jul 11, 2025 10:15am
Fierce Pharma
FDA investigates 2 deaths after Sarepta Duchenne gene therapy
Jun 25, 2025 10:26am
Nuvalent trots out strong pivotal data in FDA lung cancer push
Jun 24, 2025 6:30am
China proposal would match US clinical trial review times
Jun 16, 2025 5:30pm
Fierce Pharma
2nd patient dies after Sarepta's DMD gene therapy Elevidys
Jun 16, 2025 10:58am
FDA chides Applied Therapeutics' trial conduct in warning letter
Dec 4, 2024 11:21am
