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The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.
By Stephanie Brown HealthDay ReporterTHURSDAY, July 10, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...
The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...
In discussions with multiple potential animal health company partners to collaborate to bring Canalevia®, conditionally ...
The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...
Prices are falling for the popular obesity treatments Wegovy and Zepbound, but steady access to the drugs remains challenging ...
Merck's animal health division received Food and Drug Administration approval for its once-yearly injectable flea-and-tick treatment for dogs. Merck Animal Health said Thursday it expects its Bravecto ...
The hot flashes and night sweats that plague breast cancer survivors during years-long hormone-suppressing therapy are eased ...
Research on synthetic psychedelics progresses, and there's hope to prove psilocybin safe and effective in intractable ...
Lenacapavir is available in both oral tablet form and as subcutaneous injections. It is available as oral tablets and ...
The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...