Industry News Drugs.com – New Drug Approvals FDA Approves Tylenol with Naproxen (acetaminophen and naproxen sodium) for Over-the-Counter Treatment of PainJuly 24, 2026 FDA Approves Jideytro (zidesamtinib) for Previously Treated ROS1-Positive Non-Small Cell Lung CancerJuly 22, 2026 Glenmark Receives U.S. FDA Approval to Expand the Use of Ryaltris Nasal Spray for Children Aged 6 to Less Than 12 YearsJuly 21, 2026 Novartis Fabhalta (iptacopan) Receives FDA Traditional Approval as First and Only Complement Inhibitor to Significantly Slow Kidney Function Decline in Primary IgANJuly 17, 2026 FDA Approves Lipfendra (enlicitide) Oral PCSK9 Inhibitor to Reduce LDL-C in Adults with HypercholesterolemiaJuly 16, 2026 FDA Grants Traditional Approval to Retevmo (selpercatinib) for Locally Advanced or Metastatic RET Fusion-Positive Solid TumorsJuly 14, 2026 FDA Approves Revtorpyk (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast CancerJuly 14, 2026 FDA Approves Leqembi Iqlik (lecanemab-irmb) Subcutaneous Injection as an Initiation Dose for Early Alzheimer’s DiseaseJuly 12, 2026 FDA Approves Sarclisa Escena (isatuximab-irfc) Subcutaneous Injection for the Treatment of Multiple MyelomaJuly 10, 2026 U.S. FDA Approves Padcev plus Keytruda or Keytruda Qlex as Neoadjuvant and Adjuvant Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin EligibilityJuly 10, 2026 Drugs.com – New Drug Applications Revolution Medicines’ New Drug Application for Daraxonrasib Accepted for Review by U.S. FDA for Previously Treated Metastatic Pancreatic CancerJuly 21, 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 Saol Therapeutics Resubmits the New Drug Application for SL1009 (DCA) for the Treatment of Pyruvate Dehydrogenase Complex Deficiency (PDCD), an Ultra-Rare DiseaseJuly 7, 2026 Ascelia Pharma Provides Update on the Orviglance NDAJuly 3, 2026 Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA)June 30, 2026 Cogent Biosciences Announces Submission of New Drug Application (NDA) for Bezuclastinib in Advanced Systemic Mastocytosis (AdvSM)June 30, 2026 Replimune Announces FDA Acceptance of RP1 Biologics License Application Resubmission for Advanced MelanomaJune 26, 2026 Drugs.com – Clinical Trials News Lilly's Triple Agonist, Retatrutide, Successful in Two Additional Phase 3 Obesity Trials, Delivering Significant Improvements in Weight and A1CJuly 23, 2026 Inhibikase Therapeutics Announces FDA Orphan Drug Designation Granted to IKT-001 for the Treatment of PAHJuly 22, 2026 Investigational Once-Weekly Oral HIV Treatment Regimen of Islatravir and Lenacapavir Maintained Virological Suppression in Adults With HIV Who Switched Antiretroviral TherapyJuly 21, 2026 Agios Provides Update on Phase 2 Trial of Tebapivat in Sickle Cell DiseaseJuly 20, 2026 Acadia Pharmaceuticals Receives FDA Fast Track Designation for Remlifanserin in Alzheimer's Disease PsychosisJuly 20, 2026 Oncolytics Biotech Receives Fast Track Designation for Pelareorep in Second-Line and Later Anal CancerJuly 19, 2026 GSK Provides an Update on CALM-1 and CALM-2 Phase III Trials for Camlipixant in Refractory Chronic Cough (RCC)July 17, 2026 Boehringer Ingelheim Strengthens Obesity Pipeline as Potential First-in-Class Triple Receptor Agonist BI 3034701 Enters Phase II DevelopmentJuly 16, 2026 Takeda’s Zasocitinib Demonstrates Consistent, High Rates of Skin Clearance Across the Body, Including Hard-to-Treat and High-Impact Sites, in Phase 3 Psoriasis StudiesJuly 16, 2026 Biogen Presents Phase 2 CELIA Data at AAIC Demonstrating Meaningful Clinical Outcomes and Robust Tau Reduction with Diranersen in Early Alzheimer’s DiseaseJuly 14, 2026
