Key Takeaways In legislation enacted on Feb. 3, 2026, Congress reauthorized the rare pediatric disease priority review voucher program, clarified the scope of orphan drug exclusivity (ODE) and ...
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 ...
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, ...
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, 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 ...
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 ...
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 ...
As the pharma patent cliff approaches, delve into which important drugs are about to lose exclusivity and how the industry is reacting.
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