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 ...
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 ...
Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...
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 ...
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, ...