The US Food and Drug Administration (FDA) today released a new draft guidance document intended to explain how biological products approved under Section 351(a) of the Public Health Service Act (PHS ...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 ...
In the fifth part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss key considerations for biologics license applications (BLAs) and the Food and Drug ...
Pharmaceutical Technology on MSNOpinion
Shift in biosimilar commercial landscape essential for sector sustainability, expert says
While the regulatory landscape around biosimilars is evolving to encourage efficiency and innovation, the commercial ...
CAS explains how intellectual property intelligence enables biologics companies to reduce R&D risk, extend market exclusivity ...
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 ...
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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