Pharmaceuticals announced that the U.S. FDA has approved Revuforj as the first and only menin inhibitor for the treatment of ...

The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.

The Mental Health Watchdog calls for reforms to protect public safety, citing decades of antidepressant, electroshock, and psychedelic drug risks.

The FDA last year turned away the companies' application and asked for additional efficacy data. Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in ...

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs ...

The U.S. Food and Drug Administration is taking the first step to remove an ingredient in non-prescription cold medicines ...

The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...

The FDA has accepted for review the resubmitted BLA for prademagene zamikeracel for recessive dystrophic epidermolysis bullosa.

The FDA announced on Thursday a proposed order to remove oral phenylephrine as an active ingredient in over-the-counter (OTC) ...

The drugmaker will also get the FDA's priority review voucher, which allows a drug developer to expedite the review process ...

The FDA says oral phenylephrine, used in many over-the-counter cough and cold medicines, "is not effective as a nasal ...