Drugs.com - New Drug Approvals

1. Octapharma USA Announces Expanded FDA Approval of wilate for von Willebrand Disease Prophylaxis in Children Younger Than 6 Years

   PARAMUS, N.J., July 8, 2026 /PRNewswire/ -- On July 2, 2026, the U.S. Food and Drug Administration (FDA) approved the use of wilate® (von Willebrand Factor/Coagulation Factor VIII Complex [Human]) for routine prophylaxis to reduce the frequency...

2. FDA Grants Accelerated Approval for Trutakna (atacicept-vymj) for Adult Patients with Primary IgA Nephropathy

   BRISBANE, Calif., July 07, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Trutakna (atacicept-vymj) accelerated...

3. Vertex Announces FDA Approval for Expanded Use of Casgevy for the Treatment of People Ages 2 Years and Older With Sickle Cell Disease or Transfusion-Dependent Beta Thalassemia

   BOSTON--(BUSINESS WIRE)--Jul. 1, 2026-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has approved expanded use of Casgevy (exagamglogene autotemcel) for the treatment of people...

4. FDA Approves Tregzi (Orca-T) as First and Only Precision-Engineered Cell Therapy for Allogeneic Transplant in Adults with Hematological Malignancies

   MENLO PARK, CA, June 30, 2026 – Orca Bio, a commercial-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced the U.S. Food and Drug Administration (FDA) has approved...

5. FDA Approves Arcutis’ Zoryve (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children as Young as Age 2

   WESTLAKE VILLAGE, Calif., June 29, 2026 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the...

6. Xeomin Label Expanded for Pediatric Upper Limb Spasticity Associated With Cerebral Palsy

   June 29, 2026. The Food and Drug Administration (FDA) approved an update to the Prescribing Information for Xeomin (incobotulinumtoxinA; Merz Therapeutics, Raleigh, NC), expanding its indication to include children and adolescents aged 2 years and...

7. FDA Approves Lumvoa (veligrotug-vvze) for the Treatment of Thyroid Eye Disease

   WALTHAM, Mass.–(BUSINESS WIRE)– June 26, 2026 -- Viridian Therapeutics, Inc. (Nasdaq: VRDN), a biotechnology company focused on discovering, developing, and commercializing potentially best-in-class medicines for autoimmune and rare...

8. Skyrizi (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic Disease

   NORTH CHICAGO, Ill., June 26, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved Skyrizi (risankizumab-rzaa) for the treatment of children six years of age and older with...