The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

The Food and Drug Administration (FDA) has approved an updated label for Amyvid (florbetapir F 18 injection) to support Alzheimer disease diagnosis in patients.

Discover why synthetic food dyes are being phased out in the US, how major brands are responding, and what challenges the ...

After facing an unexpected regulatory delay last month, KalVista Pharmaceuticals has leapt into the commercial realm with the ...

Patients whose atrial fibrillation lasts longer than seven days and who do not respond well to drug therapy are now eligible ...

Label updates have been approved by the FDA for the CAR T-cell therapies Breyanzi and Abecma in large B cell lymphoma and ...

Opinion: Orrick's Irena Royzman and Dana Sublett write that judges have done a good job in multiple decisions that protect ...

The FARAPULSE PFA System now approved for pulmonary vein and posterior wall ablation in patients with persistent atrial fibrillation MARLBOROUGH, Mass., July 7, ...

The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.

The FDA has approved its requested updated versions of expanded warning labels for COVID-19 vaccines. As Healio previously ...

The Food and Drug Administration is revising the labeling of all extended-release stimulants used to treat attention-deficit hyperactivity disorder to include warnings about the risk of weight loss ...

Another BCMA-targeted agent has arrived for the treatment of multiple myeloma. | After a delay, Regeneron’s BCMA-directed ...