Drugs.com - New Drug Approvals

1. FDA Approves Tylenol with Naproxen (acetaminophen and naproxen sodium) for Over-the-Counter Treatment of Pain

   SUMMIT, N.J., July 24, 2026 — Tylenol®, the #1 doctor‑recommended pain relief brand, today announced that the U.S. Food and Drug Administration (FDA) has approved Tylenol® with Naproxen—the first and only over‑the‑counter...

2. FDA Approves Lytenava (bevacizumab-vikg) for the Treatment of Wet Age-Related Macular Degeneration

   ISELIN, N.J., July 24, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/Lytenava (bevacizumab-vikg, bevacizumab gamma) for the treatment of...

3. FDA Approves Simtriyo (centanafadine) for the Treatment of Attention-Deficit Hyperactivity Disorder (ADHD)

   PRINCETON, N.J. and TOKYO, JAPAN – July 24, 2026 – Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the U.S. Food and Drug Administration (FDA) has granted...

4. FDA Approves Jideytro (zidesamtinib) for Previously Treated ROS1-Positive Non-Small Cell Lung Cancer

   London, UK July 22, 2026 -- GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jideytro (zidesamtinib), a ROS1 selective inhibitor, for the treatment of adult patients with locally advanced or metastatic...

5. Glenmark Receives U.S. FDA Approval to Expand the Use of Ryaltris Nasal Spray for Children Aged 6 to Less Than 12 Years

   Elmwood Park, New Jersey, July 21, 2026: Glenmark Specialty S.A. (Glenmark) today announced that U.S. FDA has approved the expanded use of Ryaltris (olopatadine hydrochloride and mometasone furoate) Nasal Spray, 665 mcg/25 mcg per spray, for the...

6. Novartis Fabhalta (iptacopan) Receives FDA Traditional Approval as First and Only Complement Inhibitor to Significantly Slow Kidney Function Decline in Primary IgAN

   Basel, July 17, 2026 – Novartis today announced that the US Food and Drug Administration (FDA) has granted traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN)...

7. FDA Approves Lipfendra (enlicitide) Oral PCSK9 Inhibitor to Reduce LDL-C in Adults with Hypercholesterolemia

   RAHWAY, N.J.--(BUSINESS WIRE) July 16, 2026 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved Lipfendra (enlicitide) tablets 20 mg as an adjunct to...

8. FDA Grants Traditional Approval to Retevmo (selpercatinib) for Locally Advanced or Metastatic RET Fusion-Positive Solid Tumors

   On July 14, 2026, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET...