As millions patients struggled to fill their prescriptions for the new weight loss drugs, many have turned to compounded copies.

Biotech-stock investing has one tough test for success - and it's about to get easier ...

The FDA has granted fast-track approval for a groundbreaking gene therapy indicated for a rare genetic disorder called aromatic L-amino acid decarboxylase (AADC) deficiency.

The FDA’s concerns are not about the drug’s efficacy but rather a statistical issue with the proposed labeling. Astellas is working to address these comments and evaluate potential financial impacts.

Revuforj is the first so-called menin inhibitor cleared in the U.S., securing FDA approval for use in adults and certain ...

The U.S. Supreme Court turned away on Monday a bid by Alvogen's subsidiary Norwich Pharmaceuticals to sell a generic version ...

The U.S. patient population for Revuforj in its approved indication is roughly 2,000 according to Syndax. KMT2A leukemias ...

Last year, however, a new class came into play in this already heavily catered-for market. Lilly became the first company to ...