Regeneron Pharmaceuticals said on Wednesday the U.S. Food and Drug Administration has approved its drug for a type of blood ...

FDA updates CAR T-cell therapy labels, easing monitoring requirements and expanding access for eligible patients in oncology.

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

Lupin Limited secures FDA approval for Loteprednol Etabonate Ophthalmic Gel, enhancing treatment options for postoperative ...

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

The FDA approved Dupixent for the treatment of adults with bullous pemphigoid, a rare skin disease often uncontrolled with systemic corticosteroids, Sanofi and Regeneron announced. The FDA’s ...

Regeneron Pharmaceuticals, Inc. REGN obtained FDA approval for linvoseltamab-gcpt for the treatment of relapsed or refractory ...

The U.S. Food and Drug Administration had approved Ibtrozi (taletrectinib) for adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). The efficacy of the ...

The Food and Drug Administration (FDA) has approved Harliku ™ (nitisinone) for the reduction of urine homogentisic acid (HGA) in adult patients with alkaptonuria. Alkaptonuria (AKU) is a rare ...

FDA Approves Yeztugo as First Twice-Yearly Injectable HIV Prevention Option in the U.S. Clinical Trials Show Near-Perfect Efficacy With 99.9% of Pa ...

The US Food and Drug Administration approved a triple therapy polypill for the treatment of patients with hypertension, manufacturer George Medicines announced yesterday. The single pill (Widaplik), ...

The FDA has issued its first ever approval on a safety consultation for lab-grown fish. That makes Wildtype only the fourth company to get approval from the regulator to sell cell-cultivated ...