USFDA

23 October 2026

FDA Clears First Generic Weekly Hormone Patch, Expanding Menopause Treatment Options

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.

20 October 2026

FDA Approves Jemperli for Rectal Cancer, Offering Some Patients a Chance to Avoid Surgery and Chemotherapy

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.

16 October 2026

USFDA Expands Anktiva Approval to High-Grade Papillary Bladder Cancer After BCG Treatment Failure

The US Food and Drug Administration (FDA) has expanded the approved use of Anktiva (nogapendekin alfa inbakicept-pmln), in combination with Bacillus Calmette-Guérin (BCG), to include adults with high-grade papillary-only non-muscle-invasive bladder cancer that has not responded to BCG treatment.

12 October 2026

Rubicon Research Receives One US FDA Form 483 Observation After Satara Facility Inspection

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.

10 October 2026

FDA Approves HOVILPRI (Pritelivir), a New Oral Treatment for Difficult-to-Treat Herpes Infections

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.

8 October 2026

FDA Approves Novartis’ Rhapsido as First Treatment Specifically for Symptomatic Dermographism

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.

2 October 2026

FDA Approves First Heart Valve Designed to Grow with Children

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.

2 October 2026

FDA Flags Major GMP Violations at Fresenius Kabi Sterile Injectable Facility; Recalls and Corrective Actions Under Review

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.

29 September 2026

AbbVie’s JUVMO Gets FDA Approval for Parkinson’s Disease: New D1/D5 Targeted Treatment Approved in the U.S.

AbbVie’s JUVMO (tavapadon) has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of Parkinson’s disease in adults. The once-daily oral medicine introduces a different approach to dopamine-based treatment by selectively targeting D1/D5 receptors.

AbbVie announced on September 28, 2026, that the FDA approved JUVMO tablets for adults with Parkinson’s disease. The company describes JUVMO as the first and only selective D1/D5 receptor agonist approved for adults with Parkinson’s disease.

18 September 2026

FDA Expands Finerenone Approval to Type 1 Diabetes-Linked Kidney Disease

The U.S. Food and Drug Administration (FDA) has approved Kerendia (finerenone) for a new indication in adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D). Bayer announced it as the first FDA-approved treatment option in more than 30 years for adults with CKD associated with type 1 diabetes

FDA Clears First Generic Weekly Hormone Patch, Expanding Menopause Treatment Options

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