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

The FDA has rejected Replimune’s request for approval of RP1, adding the melanoma drug candidate to the list of assets to ...

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

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

Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid ...

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

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

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 ...

Experts see tolebrutinib as part of a broader shift toward treatments that target the neurodegeneration in MS, not just its ...

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, ...