The US Food and Drug Administration (FDA) today released a new draft guidance document intended to explain how biological products approved under Section 351(a) of the Public Health Service Act (PHS ...
The FDA proposed Thursday not adding three active ingredients in weight-loss drugs to its so-called bulks list.
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 ...
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 ...
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, ...
ROCKVILLE, Md., June 27, 2023 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a clinical-stage company developing therapeutics designed to treat cancer and ...
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Congress should pass Red Tape Elimination Act to lower prescription drug costs
Last year, 43% of U.S. adults did not take their medication as prescribed because of the cost of prescription drugs. These rising drug prices hit American seniors, small businesses, and middle-class ...
The transaction will establish a scaled, fully integrated global biosimilars platform ahead of a more than $300 billion projected global biologics loss-of-exclusivity wave over the next decade.
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 ...
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