USFDA

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Voceryq, a first-of-its-kind plasmid DNA-based immunotherapy for adults living with recurrent respiratory papillomatosis (RRP), a rare and chronic disease caused by human papillomavirus (HPV).

The U.S. Food and Drug Administration (FDA) has approved the first generic version of Climara Pro, a combination hormone therapy patch designed for women with an intact uterus. The approval introduces another treatment option for managing menopause-related symptoms and helping prevent postmenopausal osteoporosis.

U.S. Food and Drug Administration (FDA) has granted accelerated approval to Jemperli (dostarlimab-gxly) as a standalone treatment for certain adults with previously untreated stage II or stage III locally advanced rectal cancer, potentially allowing them to avoid surgery, radiation and chemotherapy.

Rubicon Research Limited has received one observation in a Form 483 issued by the United States Food and Drug Administration (US FDA) following an unannounced inspection of its manufacturing facility in Satara, Maharashtra.

The U.S. Food and Drug Administration (FDA) has approved HOVILPRI (pritelivir) tablets for the treatment of mucocutaneous lesions caused by herpes simplex virus (HSV) infection in immunocompromised adults whose infections have not responded to standard antiviral treatments.

The U.S. Food and Drug Administration (FDA) has approved Novartis’ Rhapsido® (remibrutinib) for adults with symptomatic dermographism (SD) whose symptoms are not adequately controlled with H1 antihistamines, making it the first FDA-approved treatment specifically for the condition.

The U.S. Food and Drug Administration today approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease. This innovative device may reduce the need for repeat open-heart surgeries in children with heart defects, reflecting the Trump Administration’s commitment to bringing breakthrough medical technologies to market as quickly and safely as possible.

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Fresenius Kabi USA LLC over significant Current Good Manufacturing Practice (CGMP) violations identified at the company's sterile drug manufacturing facility in Melrose Park, Illinois.