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

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.

Moberg Pharma's MOB-015 has outstanding clinical trial data, 76% cure rate, double the current standard topical, Jublia. Read ...

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

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

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

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.

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

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