The U.S. drug regulator said on Friday a unit of Johnson & Johnson issued a correction for certain lots of a part related to ...

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

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.

Surgery, a unit of Johnson & Johnson , issued a correction for certain lots of a part related to its surgical stapler and ...

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

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...

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.

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

The US Food and Drug Administration (FDA) has instructed all GLP-1 drug-makers to update their warning labels to include the ...

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