The FDA released Feb. 24 the first version of the Purple Book, a new online database of biological product information. The Purple Book is modeled after the Orange Book, a list of every prescription ...

WASHINGTON, Dec. 15, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug ...

Amgen on May 25 filed a lawsuit against the Food and Drug Administration after the agency denied the drugmaker a six-month exclusivity period for its secondary hyperparathyroidism treatment Sensipar, ...

Utidelone, a microtubule inhibitor, has received FDA orphan drug designation for pancreatic cancer, offering potential market exclusivity and tax incentives. Clinical trials show utidelone's promising ...

Phathom Pharmaceuticals Inc. (NASDAQ:PHAT) shares are trading higher Friday after the company announced a major regulatory win. What To Know: The FDA has granted 10-year new chemical entity ...

WASHINGTON, June 21-- Rep. Jan Schakowsky, D-Illinois, issued the following news release: Yesterday, Representatives Jan Schakowsky, Rosa DeLauro, Angie Craig, Lloyd Doggett, Raja Krishnamoorthi, and ...

Liquidia (NASDAQ:LQDA) late on Aug. 27 filed a request for a preliminary injunction against the U.S. FDA in a District of Columbia federal court regarding the agency's granting of 3-year exclusivity ...

As the pharma patent cliff approaches, delve into which important drugs are about to lose exclusivity and how the industry is reacting.