The U.S. Food and Drug Administration issued 18 warning letters to owners of websites illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox. The agency is aware ...

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Biohaven regarding the New Drug Application (NDA) for troriluzole for the treatment of adults with spinocerebellar ...

The recommended dosage for pediatric patients seven years and older with IBS-C is 145 mcg orally once daily, the FDA said.

At 69 years old, Debby Orcutt was diagnosed last year with pancreatic cancer, a condition so dire that her doctor refused to ...

FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, while safe, ...

The agency might dissuade patients from participating in a crucial part of our research-and-development system.

According to reporting from Reuters, reviewers at the agency pointed to an inability to differentiate from placebo to justify rejecting the drug, but an FDA office director approved the drug anyway.

The FDA has approved Kygevvi (doxecitine and doxribtimine) for the treatment of TK2d in adults and pediatric patients with an age of symptom onset on or before 12 years.

The FDA announced it will relax certain rules for approving low-cost versions of some high-priced medications.

Treatments for asthma, chronic rhinosinusitis with nasal polyps, dyslipidemia, Cushing syndrome, gonorrhea, HSCT-associated thrombotic microangiopathy, marginal zone lymphoma, motion sickness, ...

The FDA has approved Rybelsus® to reduce the risk of MACE in adults with T2DM who are at high risk for these events.