Following the ban of red dye No. 3 in the United States, experts weigh in on the potential health risks of red dye No. 40, ...
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of ...
The authors write "The Food, Drug and Cosmetic Law Section of the New York State Bar Association is delving into the changing ...
In a post-market statement on Jan. 16, Lykos gave a fresh update following what it described as a “productive” meeting with the FDA on Wednesday. “We continue to chart a path forward for an ...
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
Medpage Today on MSN3d
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 ...
A high-dose form of Novo’s obesity drug led to 20% weight loss over 72 weeks. Meanwhile, Atara got a complete response letter ...
The positions of Robert F. Kennedy Jr. on vaccines and drug companies are well known. His approach to addiction has been far ...
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
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