Industry News Drugs.com – New Drug Approvals FDA Approves Lipfendra (enlicitide) Oral PCSK9 Inhibitor to Reduce LDL-C in Adults with HypercholesterolemiaJuly 16, 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 FDA Approves Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), Each With Padcev (enfortumab vedotin-ejfv), as Treatment Before and After Surgery for Adults With Muscle-Invasive Bladder CancerJuly 9, 2026 FDA Approves Ennumo (pegfilgrastim-pccg), a Biosimilar to NeulastaJuly 9, 2026 Octapharma USA Announces Expanded FDA Approval of Wilate for von Willebrand Disease Prophylaxis in Children Younger Than 6 YearsJuly 7, 2026 FDA Grants Accelerated Approval for Trutakna (atacicept-vymj) for Adult Patients with Primary IgA NephropathyJuly 7, 2026 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 ThalassemiaJuly 1, 2026 Drugs.com – New Drug Applications 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 Sobi Receives Complete Response Letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)June 25, 2026 Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDAJune 21, 2026 Drugs.com – Clinical Trials News Boehringer Ingelheim Strengthens Obesity Pipeline as Potential First-in-Class Triple Receptor Agonist BI 3034701 Enters Phase II DevelopmentJuly 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 FDA Grants Fast Track Designation to SOTIO’s SOT109, a CDH17-targeting ADC for Colorectal CancerJuly 14, 2026 Novo Nordisk's Denecimig (Mim8) Demonstrated Positive Results in Long Term Safety and Efficacy in Phase 3 Hemophilia A FRONTIER Extension StudyJuly 10, 2026 Revolution Medicines Presents Phase 1/2 Clinical Data for Zoldonrasib Combination Regimens in Patients with RAS G12D Metastatic Pancreatic CancerJuly 2, 2026 Genentech’s Divarasib Shows Superiority in Head-to-Head Phase III Trial Against Approved KRAS G12C Inhibitors in Non-Small Cell Lung CancerJuly 1, 2026 Efzimfotase Alfa Demonstrated Improvements in Bone Health in Treatment-Naïve Pediatric Patients with Hypophosphatasia in MULBERRY Phase III TrialJune 28, 2026 Galectin Therapeutics Announces Positive Type C Meeting with the FDA for Belapectin in Patients with MASH Cirrhosis and Portal HypertensionJune 22, 2026 Merck’s Tulisokibart Met Primary and Key Secondary Endpoints in the Phase 3 ATLAS-UC Induction-only Study in Patients With Moderately to Severely Active Ulcerative Colitis (UC)June 22, 2026 Pfizer Announces Topline Phase 3 Results for Sigvotatug Vedotin in Previously Treated Metastatic Non-Squamous Non-Small Cell Lung CancerJune 22, 2026
