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

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

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

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

Lobbying against Kennedy, they say, would probably be unsuccessful and counterproductive.Instead, they hope to find areas of ...

The Prescription Drug User Fee Act date refers to the deadline set by the FDA for reviewing a NDA or Biologics License Application.

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

Treatments for hair regrowth include medicated formulas, supplements, lasers, and complementary remedies, such as massage and ...

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

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

Robert F. Kennedy's stance on reforming federal health agencies does have some merit, but a doctor believes Kennedy's efforts ...