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 FDA approved a wide range of therapies in 2024, including many new molecular entities and biological products.
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
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 ...
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 ...
Zunveyl, an oral medication, is a better-tolerated version of galantamine for managing mild to moderate Alzheimer's symptoms.
A non-opioid painkiller from Vertex Pharmaceuticals could become a blockbuster, but questions remain on whether it will prove ...