Jan 15 (Reuters) - The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration ...

Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite ...

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 ...

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

FDA delays drug reviews for two priority voucher drugs amid safety and efficacy concerns, extending timelines for Sanofi and Disc Medicine products.

Eli Lilly and Company’s LLY stock declined 3.8% on Thursday after the FDA reportedly delayed its decision on LLY’s ...

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.

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

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 ...

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