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

Johnson & Johnson JNJ announced that it has submitted a new drug application (NDA) to the FDA seeking approval for its ...

This latest approval builds on an earlier liquid formulation of generic methimazole for feline hyperthyroidism, which ...

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

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 ...

Neha Anand, Analyst, Biopharma Intelligence Services, Citeline, explains how the approval of Embrelis marks a pivotal moment ...

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

Vusolimogene oderparepvec is a genetically modified herpes simplex type 1 virus designed to directly destroy tumors and generate an anti-tumor immune response.

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

The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...

Supporters believe that FDA approval will make the drug more accessible. Right now, traditional psilocybin therapy offered at healing centers in the state is not covered by insurance.

Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s top drug regulator, the agency confirmed Monday.