FDA panel rejects drug that could combat rare terminal illness 02:40 "Some people might think it's alarming that one in three drugs are having a safety problem after approval.If you believe this ...

Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1 ...

Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...

Replimune Group Inc. shares sank to their lowest point ever after US regulators rejected a skin cancer treatment from the ...

The FDA has decided not to approve glofitamab plus gemcitabine and oxaliplatin to treat certain patients with relapsed/refractory DLBCL.

About a third of the drugs that the Food and Drug Administration deems safe and effective go on to have major safety issues years after their approval, researchers report in JAMA.. The finding ...

Among more than 200 new medications approved by the Food and Drug Administration between 2001 and 2010, nearly one-third were affected by a post-market safety event, according to a new study.

The U.S. Food and Drug Administration's recent approval of aducanumab, a treatment for Alzheimer's disease, has drawn decidedly mixed reviews. Advocates for patients, such as the Alzheimer's ...

Issues. May 2025, Medicaid ... Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, approved the drug under the FDA’s accelerated approval pathway for a subset of ...

On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics ...

In 1976, the Eagles released the song, “Life in the Fast Lane,” as part of their iconic album, Hotel California.Approximately 16 years later, the Food and Drug Administration began offering ...

FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.