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

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

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.

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

Merck (MRK) stock in focus as its lung disease drug Winrevair gains FDA priority review for a label update based on Phase 3 ...

The FDA says it will allow three new color additives made from natural sources to be used in the nation’s food supply.

The U.S. Food and Drug Administration said on Friday it had eliminated risk evaluation and mitigation strategies (REMS), a ...

Regeneron Pharmaceuticals has won FDA accelerated approval of its Lynozyfic treatment for certain patients with the blood cancer multiple myeloma.

It may be a year later than originally planned, but Regeneron Pharmaceuticals Inc. is set to commercialize Lynozyfic (linvoseltamab) in the U.S. following FDA approval for use in adults with relapsed ...

Regeneron Pharmaceuticals, Inc. (REGN) on Wednesday announced that the U.S. Food and Drug Administration has granted accelerated approval for its Lynozyfic to treat adult patients with relapsed or ...