Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of ...
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HHS Inspector General Raises Concerns Over FDA's Accelerated ApprovalsOf the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
The authors write "The Food, Drug and Cosmetic Law Section of the New York State Bar Association is delving into the changing ...
Made from petroleum and chemically known as erythrosine, red dye No. 3 is a synthetic color additive used to give foods and ...
The positions of Robert F. Kennedy Jr. on vaccines and drug companies are well known. His approach to addiction has been far ...
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
Citi keeps a Buy rating on Exelixis (EXEL) with a $38 price target after the company announced that it has been notified by the FDA that the ...
(MENAFN- EIN Presswire) Novamigra Tx Announces Successful Pre-IND Meeting with FDA for Migraine Prophylaxis Asset VRG-145, Paving Way for Accelerated Clinical Development BUDAPEST, HUNGARY ...
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
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