Red dye No. 3 is found in at least dozens of candy, food and beverage products, but some of the most popular brands either ...
The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end ...
The list includes several groundbreaking therapies that are expected to change the treatment landscape for several diseases and conditions.
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
Zepbound is a dual-activating medication that combines glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like ...
Incyte (INCY) and Syndax Pharmaceuticals (SNDX) announced that the U.S. Food and Drug Administration has approved Niktimvo ...
The New Brunswick, N.J., pharmaceutical giant said the FDA accepted the application through its Real-Time Oncology Review program, which allows for an earlier submission of topline efficacy and safety ...
Less than two months after scoring what analysts deemed a "best-case" FDA approval for its cardiomyopathy drug Attruby, ...
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...