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

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

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

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

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 ...

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

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

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 ...

Some experts say that actually shows our drug approval ... “The fact that a post-market safety event has been detected for 1 in 3 drugs tells me that the FDA is looking for these issues, ...

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...