From 1,300 drugs, they narrowed the list down to ten FDA-approved candidates. Then, by analyzing the medical records of 1.4 ...

Replimune (REPL) stock in focus as the FDA rejects its lead drug RP1 as part of a combination regimen for melanoma, a type of ...

The U.S. Food and Drug Administration has approved GSK's prefilled syringe presentation of Shingrix (zoster vaccine ...

Replimune, which was seeking approval of RP1 in combination with Bristol Myers Squibb's Opdivo for the treatment of advanced melanoma, on Tuesday said the FDA issued a so-called complete response ...

Marty Makary, commissioner of the FDA, is naming George Tidmarsh director of the Center for Drug Evaluation and Research.

The U.S. Food and Drug Administration said on Monday it has appointed George Tidmarsh, a seasoned biotech executive and ...

The Food and Drug Administration has granted permission for Juul to continue selling its e-cigarettes, offering some reprieve ...

Johnson & Johnson has submitted a NDA seeking approval from the FDA for icotrokinra to treat moderate to severe plaque psoriasis (PsO).

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

FDA regulators said Thursday that Juul’s studies show its e-cigarettes are less harmful for adult smokers, who can benefit ...

An analysis from the Congressional Budget Office warns that cuts to the National Institutes of Health and FDA drug reviews could significantly reduce the number of new medications reaching the U.S.

Pro-life medical groups are urging Health and Human Services Secretary Robert Kennedy Jr. to reexamine the FDA’s broad ...