The U.S. Food and Drug Administration (FDA) has approved two new biosimilars as reference products for Prolia (denosumab) and ...

FDA announces major reforms to streamline biosimilar approvals, potentially saving Americans billions on prescription drug ...

Dr. George Tidmarsh, the FDA's top drug regulator, was placed on leave amid controversy over the drug approval process and a ...

Developers of biosimilars, medicines that are near-identical copies of biologic drugs, will no longer be required to conduct clinical trials to prove effectiveness.

Shares of Sarepta Therapeutics Inc. plunged in extended trading Monday after the biotechnology company disclosed disappointing drug-trial data, which could lengthen the timeline of the regulatory ...

D r. George Tidmarsh, the FDA drug regulator who was placed on leave and complained of a “toxic” work environment in an ...

Day Safety Update Submitted to FDA ORCA-OL Long-Term Safety Trial Successfully ConcludedDSMC Completes Final Review of Cytisinicline, Finds No Drug Safety Concerns SEATTLE and VANCOUVER, British ...

Vinay Prasad, chief of the FDA’s Center for Biologics Evaluation and Research, is planning to publish a paper this month to outline his office’s thinking of accelerating gene editing reviews.

Chiesi Global Rare Diseases, a business unit of the Chiesi Group, and Protalix BioTherapeutics, Inc. (NYSE American: PLX), have requested a re-examination of the recent negative opinion issued by the ...

- Duchenne (SGT-003): 23 participants have been dosed in the INSPIRE DUCHENNE trial as of October 31, 2025; Solid expects to ...

FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...