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FDA says CDER researchers have developed a three-step process to promote viral clearance during continuous manufacturing of therap...[ Price : $8.95]
A bipartisan group of six senators quizzes FDA on the potential conflicts of interest in agency contracts with McKinsey since the ...[ Price : $8.95]
FDA warns Japans Toyobo Co. about a CGMP violation in its manufacturing of finished drugs.[ Price : $8.95]
Federal Register notice: FDA posts a draft guidance entitled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submi...[ Price : $8.95]
In comments to FDA, drug companies and industry organizations urge the agency to develop additional and broader guidance on patien...[ Price : $8.95]
Citing a lack of evidence, AstraZenecas Alexion drug unit discontinues its CHAMPION-ALS Phase 3 clinical trial of Ultomiris (ravul...[ Price : $8.95]
Cardinal Health recalls three models of its Monoject Saline Flush Prefilled Syringes because their plunger may pull air into the s...[ Price : $8.95]
FDA approves the first Covid-19 vaccine Pfizer-BioNTechs vaccine that is now under the trade name Comirnaty.