Industry News Drugs.com – New Drug Approvals FDA Approves Hovilpri (pritelivir) for the Treatment of Mucocutaneous Herpes Simplex Virus (HSV) LesionsOctober 12, 2026 FDA Approves Weltruza (olanzapine) Once-Monthly Subcutaneous Injection for the Treatment of Adults with SchizophreniaOctober 9, 2026 FDA Approves Genentech’s Tecentriq in Combination With a Fluoropyrimidine and Oxaliplatin for The Adjuvant Treatment of a Certain Type of Stage III Colon CancerOctober 8, 2026 Novartis Rhapsido (remibrutinib) Receives FDA Approval as First Treatment for Symptomatic DermographismOctober 7, 2026 Pfizer’s Tukysa Regimen Receives FDA Approval as Front-Line Maintenance Treatment for HER2+ Metastatic Breast CancerOctober 6, 2026 Lilly's Jaypirca (pirtobrutinib), the First-and-Only Approved Non-Covalent BTK Inhibitor, Receives Expanded Indication from U.S. FDA for Certain Patients with Previously Untreated CLL/SLLOctober 2, 2026 U.S. Food and Drug Administration Approves Expanded Indication for Bristol Myers Squibb’s Camzyos (mavacamten) for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) in Adults and Pediatric Patients*September 30, 2026 FDA Approves Emcitate (tiratricol) for the Treatment of Patients with MCT8 DeficiencySeptember 28, 2026 FDA Approves Degevma (denosumab-adet), a Biosimilar to XgevaSeptember 28, 2026 FDA Approves Juvmo (tavapadon) for the Treatment of Parkinson's DiseaseSeptember 28, 2026 Drugs.com – New Drug Applications Novo Provides Update on the Denecimig Biologics License Application (BLA) in the USOctober 2, 2026 FDA Accepts New Drug Application for CeleCor’s Investigational Heart-Attack Drug ZalunfibanSeptember 29, 2026 Unicycive Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum CarbonateSeptember 29, 2026 Gossamer Bio Submits New Drug Application to U.S. FDA for Seralutinib for the Treatment of Pulmonary Arterial HypertensionSeptember 22, 2026 Elevar Therapeutics Receives FDA Conditional Acceptance of Lyrfigtu as Brand Name for LirafugratinibSeptember 22, 2026 LEO Pharma Announces FDA Acceptance of Dersimelagon NDA with Priority ReviewSeptember 18, 2026 Efzimfotase Alfa Granted Priority Review in the US as Treatment for Patients with Hypophosphatasia Aged 2 Years and OlderSeptember 18, 2026 Xenon Announces Azetukalner NDA Submission to FDA for Focal Seizures and Provides Update on Psychiatry Clinical ProgramSeptember 17, 2026 Aquestive Therapeutics Announces Resubmission of New Drug Application to FDA for Anaphylm™ (dibutepinephrine) Sublingual FilmSeptember 17, 2026 U.S. FDA Accepts New Drug Application Under Priority Review for Takeda’s Zasocitinib in Moderate-to-Severe Plaque Psoriasis, with Potential to Redefine Oral Treatment ExpectationsSeptember 14, 2026 Drugs.com – Clinical Trials News SAB BIO Receives FDA Fast Track Designation for SAB-142 in Stage 3 Type 1 DiabetesOctober 13, 2026 Bristol Myers Squibb Announces Positive Topline Results from the Interim Analysis of Phase 3 ACTION-1 for RYZ101, RayzeBio’s Radiopharmaceutical Therapy, in Patients with GEP-NETsOctober 12, 2026 Bristol Myers Squibb Announces Phase 3 ALOFT-IPF Trial Evaluating Admilparant in Adults with Idiopathic Pulmonary Fibrosis Met Primary EndpointOctober 12, 2026 Efzimfotase Alfa Showed Numerical Improvement in Six-Minute Walk Test Achieving Mean Difference of 17.05 Metres vs Placebo in Treatment-Naïve Adolescents and Adults with Hypophosphatasia at Week 25 in HICKORY Phase III TrialOctober 11, 2026 Merck Presents One-Year Results from the Pivotal Phase 2b/3 BRUNELLO Study Evaluating Remigromig, a Tri-Specific Agonist of the Wingless-Related Integration Site (Wnt) Pathway, in Adults with Diabetic Macular EdemaOctober 10, 2026 Roche Presents New Phase III One-Year Data for Vamikibart in Uveitic Macular EdemaOctober 9, 2026 AbbVie's Telisotuzumab Adizutecan (Temab-A) Receives Two Breakthrough Therapy Designations From the U.S. FDA for CRC and NSCLCOctober 7, 2026 Zealand Pharma Announces Positive Phase 2 ZUPREME-2 Topline Results for Amylin Analog Petrelintide in People with Overweight or Obesity and Type 2 DiabetesOctober 7, 2026 Capricor Therapeutics Presents Positive HOPE-3 Open-Label Extension Data for Deramiocel for Upper Limb Function in Duchenne Muscular DystrophyOctober 5, 2026 Biogen’s Litifilimab Demonstrates Rapid and Durable Efficacy in New 52-Week Phase 2 Data from Ongoing Phase 2/3 AMETHYST Study, Reinforcing Its Potential as a First-in-Class Therapy for Cutaneous Lupus ErythematosusOctober 2, 2026
