Industry News Drugs.com – New Drug Approvals FDA Approves Caplyta (lumateperone) as an Adjunctive Therapy for the Treatment of Major Depressive Disorder (MDD) in AdultsNovember 6, 2025 FDA Approves Linzess (linaclotide) for Children 7 Years and Older with Irritable Bowel Syndrome with ConstipationNovember 5, 2025 FDA Approves Kygevvi (doxecitine and doxribtimine) for the Treatment of Thymidine Kinase 2 DeficiencyNovember 3, 2025 FDA Grants Interchangeable Designation to Fresenius Kabi’s Biosimilars Conexxence and Bomyntra (denosumab-bnht)November 2, 2025 FDA Grants Interchangeability Designation to Celltrion's Denosumab Biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo)October 30, 2025 Lilly's Omvoh (mirikizumab-mrkz) Approved by U.S. FDA as a Single-Injection Maintenance Regimen in Adults with Ulcerative ColitisOctober 27, 2025 FDA Approves Updated Indication for Winrevair (sotatercept-csrk) in Adults with Pulmonary Arterial Hypertension (PAH, WHO Group 1 Pulmonary Hypertension)October 27, 2025 Syndax Announces FDA Approval of Revuforj (revumenib) in Adult and Pediatric Patients with Relapsed or Refractory NPM1 Mutated Acute Myeloid LeukemiaOctober 24, 2025 FDA Approves Lynkuet (elinzanetant) for Moderate to Severe Hot Flashes Due to MenopauseOctober 24, 2025 FDA Approves Javadin (clonidine hydrochloride) Oral Solution for the Treatment of HypertensionOctober 24, 2025 Drugs.com – New Drug Applications FDA Issues Complete Response Letter for Biohaven's Vyglxia (troriluzole) New Drug Application for Spinocerebellar AtaxiaNovember 5, 2025 Replimune Announces FDA Acceptance of BLA Resubmission of RP1 for the Treatment of Advanced MelanomaOctober 20, 2025 Denali Therapeutics Announces FDA Review Extension of BLA for Tividenofusp Alfa for the Treatment of MPS II (Hunter Syndrome)October 13, 2025 Sentynl Therapeutics Updates On Its NDA for CUTX-101October 1, 2025 Novo Nordisk Resubmits Awiqli to the FDA with Potential to be the First Once-Weekly Basal Insulin Treatment for Adults with Type 2 DiabetesSeptember 29, 2025 FDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) Solely Related to Observations Identified at Catalent Indiana LLC Fill-Finish FacilitySeptember 23, 2025 FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian CancerSeptember 10, 2025 Saol Therapeutics Receives Complete Response Letter from FDA for SL1009 (DCA) for the Treatment of Pyruvate Dehydrogenase Complex Deficiency (PDCD)September 8, 2025 Achieve Life Sciences Announces FDA Acceptance of Cytisinicline New Drug Application for Treatment of Nicotine Dependence for Smoking CessationSeptember 3, 2025 FDA Accepts Shionogi’s Ensitrelvir NDA for Review as the First Oral Therapy for the Prevention of COVID-19 Following ExposureSeptember 3, 2025 Drugs.com – Clinical Trials News Novo Nordisk's CagriSema Associated with Significant Reduction in Blood Pressure and Showed Anti-Inflammatory Effects While Reducing the Proportion of Patients at Risk of Developing Heart Disease Over TimeNovember 6, 2025 Lilly and U.S. Government Agree to Expand Access to Obesity Medicines to Millions of AmericansNovember 6, 2025 Novo Nordisk Announces Agreement With the U.S. Administration to Bring GLP-1s to More Americans at a Lower CostNovember 6, 2025 Novo Nordisk Presents Four New Analyses on Oral Semaglutide 25 mg (Wegovy® in a Pill) at ObesityWeek® 2025November 5, 2025 New Phase 3 Data Show Takeda’s Dengue Vaccine Delivers 7 Years of Sustained Protection Against Infection and HospitalizationNovember 3, 2025 Gefurulimab Demonstrates Statistically Significant and Clinically Meaningful Improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) at Week 26 with Clinically Meaningful Improvement Seen as Early as Week One in Adults with gMG in PREVAIL Phase III TrialOctober 30, 2025 Novartis Ianalumab First Drug to Reduce Disease Activity and Patient Burden in Sjögren’s Disease Phase III TrialsOctober 29, 2025 Aldeyra Therapeutics Announces Positive Results from Phase 2 Clinical Trial in Alcohol-Associated Hepatitis, Focuses RASP Product Candidate Pipeline on Next-Generation MoleculesOctober 28, 2025 Alphamab Oncology Announces Biparatopic HER2-targeting ADC JSKN003 Was Granted Fast Track Designation by FDA for the Treatment of PROCOctober 28, 2025 Heidelberg Pharma Receives Fast Track Designation from the US FDA for its Lead ADC Candidate HDP-101 for the Treatment of Multiple MyelomaOctober 23, 2025
