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

The drugs that gained FDA approval right before the deadline for their review were more likely to have post-market safety issues. On the flip-side, drugs with the quickest approvals (under 200 ...

Shares fell 75% to $3.04, putting the stock on track for a record closing low, according to Dow Jones Market Data. The stock ...

FDA issues a complete response letter for glofitamab's second-line DLBCL indication, highlighting ongoing scrutiny in ...

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.

While the CRL derails a near-term clearance, one analyst described the rejection as more of “a speed bump to approval, rather ...

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.

Biogen was expecting a population of around 1 million to 2 million patients to be eligible for the drug. Instead, the FDA approved the drug under a much broader label, making all 6 million U.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 ...

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.

On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics ...