Drugs.com - New Drug Approvals
New drug approvals news from Drugs.com. Comprehensive, up-to-date drug news for consumers and healthcare professionals.
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FDA Grants Accelerated Approval to Tudriqev (vusolimogene oderparepvec-wtpg) in Combination with Nivolumab for Unresectable Advanced Cutaneous Melanoma
WOBURN, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration... -
FDA Approves mFLUSIVA (influenza vaccine, mRNA) for the Prevention of Seasonal Influenza
CAMBRIDGE, MA / ACCESS Newswire / August 5, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mFLUSIVA® (mRNA-1010), a new vaccine against seasonal influenza, for use in all adults... -
FDA Approves Mucinex 12HR Cold & Fever Multi-Symptom (dextromethorphan, guaifenesin and naproxen) for Cold & Flu Symptoms
NUTLEY, N.J., AUGUST 5, 2026 – Reckitt announced today a milestone for the cold and flu category and the company: Mucinex® 12HR Cold & Fever Multi-Symptom is the first U.S. Food and Drug Administration (FDA)-approved over-the-counter... -
FDA Approves Orzeyful (oveporexton) to Treat the Underlying Cause of Narcolepsy Type 1
OSAKA, Japan and CAMBRIDGE, Massachusetts, August 5, 2026 – Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) approved Orzeyful™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the... -
FDA Approves Pluvicto for PSMA+ Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Basel, July 31, 2026 – Novartis today announced the US Food and Drug Administration (FDA) approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for patients with... -
FDA Approves Garzulys (insulin aspart-fsan), a Biosimilar to NovoLog
CHICAGO--- July 30, 2026 -- Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company headquartered in Chicago and focused on the development and commercialization of generic injectable medicines... -
FDA Approves Gwyn Lo (norelgestromin and ethinyl estradiol) Once-Weekly Contraceptive Patch
PITTSBURGH, July 29, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has approved Gwyn Lo™ (norelgestromin and ethinyl estradiol transdermal... -
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...