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The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.
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 ...
The U.S. Food and Drug Administration updated its blood donation guidelines. Now, it goes off individual risk assessment ...
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 ...
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
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 ...
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InvestorsHub on MSNKlotho Neurosciences Shares Jump as FDA Grants Orphan Drug Status for ALS TherapyShares of Klotho Neurosciences, Inc. (NASDAQ:KLTO) surged 22% following news that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s gene therapy ...
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