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F.D.A. Posts Collection of Letters Outlining Concerns About New Drugs
The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.
FDA Publishes Full Texts of Response Letters to Drug Applications
By Stephanie Brown HealthDay ReporterTHURSDAY, July 10, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...
Moderna gets full US approval for COVID shot in at-risk children 6 months and older
The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...
Enrollment Initiated in Jaguar Health Study of its FDA Conditionally Approved Canalevia-CA1 Prescription Drug for Dogs
In discussions with multiple potential animal health company partners to collaborate to bring Canalevia®, conditionally ...
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FDA, in policy shift, publishes some drug rejection letters
The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...
Merck Animal Health's Flea-and-Tick Treatment Approved in U.S.
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 ...
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Neurizon on track to lift FDA clinical hold on ALS drug, eyes Healey trial in Q4 CY25
Neurizon Therapeutics has announced progress to lift a US Food and Drug Administration (FDA) clinical hold on its lead drug .
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Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
Arcus Biosciences' Pancreatic Cancer Treatment Gets Orphan Drug Status
Arcus Biosciences announced that the Food and Drug Administration has granted its pancreatic cancer treatment, quemliclustat, with an orphan drug designation. The company said it expects its ongoing ...
New HIV drug hailed, but can SA afford it?
Lenacapavir is available in both oral tablet form and as subcutaneous injections. It is available as oral tablets and ...
FDA updates blood donation guidelines to try and increase number of donors
The U.S. Food and Drug Administration updated its blood donation guidelines. Now, it goes off individual risk assessment ...