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.

Diabetic retinopathy affects almost 10 million people in the US and is the third FDA-approved indication for Susvimo, which is also approved for treating neovascular or ‘wet’ age-related macular ...

SWEATING THE MAHA REPORT — A report expected today from Robert F. Kennedy Jr. on childhood chronic diseases could spark ...

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

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

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

The COPD approval marks the fifth Nucala has received from the FDA, following green lights in severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis and ...

According to the CDC, cases of myocarditis and pericarditis are rare with the vaccines and, in most cases, resolve within a ...

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

On May 6, 2025, the U.S. Court of Appeals for the Federal Circuit refined the boundaries of injunctive relief under the Hatch ...

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

Combined data from Studies CL-QRX003-002 and CL-QRX003-003 is anticipated to provide QRX003 with the broadest possible label ...