The US Food and Drug Administration (FDA) today released a new draft guidance document intended to explain how biological products approved under Section 351(a) of the Public Health Service Act (PHS ...
As part of a push to increase insulin competition and bring down the price of insulin, Rep. Diana DeGette (D-CO) and Tom Reed (R-NY) introduced a bill on Monday that aims to make certain US Food and ...
The U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) share jurisdiction over animal biological products. The two agencies released a Charter for the Jurisdiction ...
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, ...
In the fourth part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss the Food and Drug Administration’s requirements and standards for approval of biosimilar ...
Phathom Pharmaceuticals has shot up ~125% in Friday trading after the U.S. FDA granted their Citizen Petition regarding the expiration date of new chemical entity exclusivity for their drug Voquezna ...
WESTON, Fla., April 27, 2026 /PRNewswire/ - Apotex, in collaboration with Orbicular Pharmaceutical Technologies Pvt. Ltd. and Gland Pharma Limited, today announced that the U.S. Food and Drug ...
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