Industry News Drugs.com – New Drug Approvals FDA Grants Accelerated Approval to Zenbexus (iberdomide) in Combination with Daratumumab and Hyaluronidase-fihj and Dexamethasone for the Treatment of Multiple MyelomaAugust 13, 2026 FDA Grants Accelerated Approval to Tudriqev (vusolimogene oderparepvec-wtpg) in Combination with Nivolumab for Unresectable Advanced Cutaneous MelanomaAugust 6, 2026 FDA Approves mFLUSIVA (influenza vaccine, mRNA) for the Prevention of Seasonal InfluenzaAugust 4, 2026 FDA Approves Mucinex 12HR Cold & Fever Multi-Symptom (dextromethorphan, guaifenesin and naproxen) for Cold & Flu SymptomsAugust 4, 2026 FDA Approves Orzeyful (oveporexton) to Treat the Underlying Cause of Narcolepsy Type 1August 4, 2026 FDA Approves Pluvicto for PSMA+ Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)July 31, 2026 FDA Approves Garzulys (insulin aspart-fsan), a Biosimilar to NovoLogJuly 29, 2026 FDA Approves Gwyn Lo (norelgestromin and ethinyl estradiol) Once-Weekly Contraceptive PatchJuly 29, 2026 FDA Approves Simtriyo (centanafadine) for the Treatment of Attention-Deficit Hyperactivity Disorder (ADHD)July 24, 2026 FDA Approves Tylenol with Naproxen (acetaminophen and naproxen sodium) for Over-the-Counter Treatment of PainJuly 24, 2026 Drugs.com – New Drug Applications Scholar Rock Announces FDA Review of Apitegromab Biologics License Application (BLA) for Spinal Muscular Atrophy (SMA) to Progress with Second Fill-Finish FacilityAugust 7, 2026 Saol Therapeutics Announces the Acceptance of Resubmission of SL1009 (DCA) by the FDA with PDUFA Date of Dec. 30, 2026July 27, 2026 Revolution Medicines’ New Drug Application for Daraxonrasib Accepted for Review by U.S. FDA for Previously Treated Metastatic Pancreatic CancerJuly 21, 2026 BridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1July 21, 2026 Camurus’ NDA Resubmission for CAM2029 in Acromegaly Accepted for Review by the US FDAJuly 16, 2026 Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in NarcolepsyJuly 14, 2026 Apnimed Announces FDA Acceptance of New Drug Application for AD109, An Investigational Oral Pill to Treat Adults with Obstructive Sleep ApneaJuly 13, 2026 U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Mezigdomide in Patients with Relapsed or Refractory Multiple MyelomaJuly 12, 2026 Elevar Therapeutics Receives FDA Complete Response Letter for Combination of Rivoceranib and Camrelizumab as a First-line Treatment for Unresectable or Metastatic Hepatocellular CarcinomaJuly 10, 2026 Immunome Announces U.S. FDA Acceptance of New Drug Application for Varegacestat for the Treatment of Adults with Desmoid TumorsJuly 7, 2026 Drugs.com – Clinical Trials News AbCellera Announces Positive Top-Line Phase 2 Clinical Trial Results for ABCL635, Demonstrating Significant Reduction in Frequency and Severity of Vasomotor Symptoms and a Favorable Tolerability ProfileAugust 10, 2026 BioInvent Receives FDA Fast Track Designation for BI-1808 for the Treatment of Ovarian CancerAugust 7, 2026 Aclaris Therapeutics Receives Fast Track Designation for Modzatinib (ATI-2138) for Moderate to Severe Lichen Planus (LP)August 6, 2026 Lexeo Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for LX2020 for the Treatment of PKP2 Arrhythmogenic CardiomyopathyAugust 5, 2026 Lilly's Olomorasib Receives U.S. FDA's Breakthrough Therapy Designation for the Treatment of Previously Treated KRAS G12C-Mutant Advanced Pancreatic CancerAugust 3, 2026 Aravax Awarded FDA Fast Track Designation for PVX108, a Next-Generation Immunotherapy for the Treatment of Peanut AllergyAugust 3, 2026 Novo Nordisk Provides Update on the ZEUS Phase 3 Trial of Ziltivekimab in People with ASCVD, CKD and InflammationJuly 31, 2026 Abivax Announces Positive Pre-NDA Interaction with the FDA for ObefazimodJuly 29, 2026 Capricor Therapeutics Provides Update on FDA Advisory Committee Meeting for DeramiocelJuly 29, 2026 Insilico Medicine Receives FDA Fast Track Designation for ISM6331, the AI-driven Pan-TEAD Inhibitor, in Advanced MesotheliomaJuly 29, 2026
