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 ...

With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug ...

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 ...

Parkinson's is a progressive neurodegenerative disease that is currently incurable. It is typically only diagnosed once ...

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

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

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.

In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...

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.

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.