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

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

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

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

But the FDA declared months ago that the shortages of semaglutide and tirzepatide injections had ended, effectively ending flexibilities for compounded products. The grace period for manufacturers to ...

A new study has led to Health and Human Services Secretary Robert F. Kennedy, Jr. to order a “complete review” of the ...

WASHINGTON - The Food and Drug Administration has directed Pfizer and Moderna to expand warning labels on their COVID-19 vaccines to include risks of a heart injury side effect associated with the ...

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

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

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

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