An FDA advisory committee on Wednesday unanimously voted against recommending approval of the PARP inhibitor talazoparib ...

GSK (NYSE:GSK) announced Thursday that the U.S. FDA has further broadened the label for its asthma therapy, approving the ...

The FDA approved three natural food additives. Food and nutrition experts share what that means for families and our food ...

The FDA has told vaccine manufacturers to expand the warning labels on their COVID-19 shots with more information about the ...

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels about heart inflammation.

The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at ...

The ODAC deemed the results from TALAPRO-2 are not sufficient to conclude a favorable benefit-risk profile for adding ...

The agency is planning a new review process that could result in ingredient bans or additional labeling requirements, ...

The FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in ...

Recent FDA updates in the areas of cardiac intervention, hypertension and arrhythmia disorders expand the pool of available ...

On May 8, the Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib for ...

Capricor Therapeutics is seeking FDA approval for CAP-1002, targeting heart function in Duchenne Muscular Dystrophy patients.