Doron Therapeutics, a clinical-stage biotechnology company based in Chapel Hill, has received a Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration ...
Fapon Biopharma, a biotech innovator in developing therapeutic antibodies and fusion proteins, is pleased to announce that the U.S. Food and Drug ...
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Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular embolotherapy, announced that it recently submitted to the U.S. Food and Drug Administration (FDA) ...
including the New Drug Applications seeking FDA approval and the MAA and EU-M4all seeking EMA approval of lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be ...
NASHVILLE, Tenn. and SHANGHAI, Feb. 18, 2025 /PRNewswire/ -- Specialty pharmaceutical companies Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) and SciClone Pharmaceuticals (Holdings) Limited ...
HLB logo (courtesy of HLB) As of 9:40 a.m. on the same day ... If FDA approval is received, it is expected to be the first FDA new drug approval for a domestically produced anticancer drug. However, ...
We never sold the combination in the countries where it's banned. Our exports were done only after getting valid product permissions from the State FDA and required export NOCs,' said Arvind Sharma, ...
Avobis Bio LLC, a clinical stage company developing implantable cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AVB-114, the ...
Palghar: The Union health ministry has stopped operations and production of Aveo Pharmaceuticals Ltd. (Aveo) following reports that the company had been exporting unapproved drug combinations ...
MELBOURNE, Australia, Feb. 26, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration ...
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What’s the Difference Between the FDA and the USDA?The Center for Food Safety and Applied Nutrition (CFSAN), which is a part of the FDA, regulates drugs ... The FDA’s logo doesn’t appear on the millions of nutrition labels it approves each ...
The logo of Danish drugmaker Novo Nordisk in their offices in Hillerod, Denmark, September 26, 2023. REUTERS/Tom Little/File Photo Novo Nordisk on Monday revealed weaker-than-expected data from a ...
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