Anxious and bewildered, some drugmakers are reaching out to their lobbyists about how Robert Kennedy’s pending nomination ...

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

Pharmaceutical industry representatives in Washington are scrambling to measure the damage Robert F. Kennedy Jr. might inflict on the FDA.

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.

Eyenovia’s stock craters to its lowest point in its six-year lifespan as a public company following the biotech’s termination ...

Robert F. Kennedy Jr.’s selection Thursday as President-elect Donald Trump’s Health and Human Services secretary nominee sent shockwaves through Washington.