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FDA warns Chinas Tianjin Kilo Pharmaceutical Sci-tech Co. about CGMP deviations the agency found in records it requested on the co...[ Price : $8.95]
FDA warns Indias Eugia Pharma about CGMP violations at its drug manufacturing facility in Kolthur Village.[ Price : $8.95]
President Donald Trump selects White House health policy adviser Heidi Overton as his nominee to become FDA commissioner.[ Price : $8.95]
McGuireWoods partner Clint Narver announces his departure from the law practice to rejoin FDA as director of the Office of Compoun...[ Price : $8.95]
Amylyx Pharmaceuticals says it will file an NDA by the end of the year for its investigational drug avexitide.[ Price : $8.95]
Valisure files a lawsuit against the United States Pharmacopeia, accusing the standards-setting organization of making false and m...[ Price : $8.95]
FDA posts a draft revised guidance intended to help drug developers determine whether a proposed product should be submitted throu...[ Price : $8.95]
While Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., European regulators have recommended th...