The FDA has issued a complete response letter to AstraZeneca regarding its application for subcutaneous administration of ...

Jan 15 (Reuters) - The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track program after agency scientists flagged safety and ...

The FDA has delayed approval of Aquestive Therapeutics’ new drug application seeking approval of Anaphylm, a sublingual epinephrine film for the treatment of Type 1 allergic reactions, including ...

FDA delayed fast-track reviews for multiple drugs after safety and efficacy concerns, including adverse events and a reported patient death.

The discovery of a tumor in a patient who received REGENXBIO’s gene therapy for Hurler syndrome prompted the FDA to place a hold on that program along with the company’s Hunter syndrome program, which ...

Alvotech has five approved drugs, including biosimilars of AbbVie's Humira, Johnson & Johnson's Stelara/Simponi, and Eylea. See why ALVO stock is a Strong Buy.

Much is riding on Travere Therapeutics’ bid to gain an expansion for Filspari to treat focal segmental glomerulosclerosis (FSGS). The indication represents a $2 billion peak sales opportunity in the U ...

A central nervous system (CNS) tumor has prompted the FDA to place clinical holds on two Regenxbio gene therapies, including ...

The Phase III AMETHYST study is currently assessing litifilimab’s safety and efficacy, with results anticipated in 2027.