Industry News Drugs.com – New Drug Approvals FDA Approves Lyrfigtu (lirafugratinib) for the Treatment of Cholangiocarcinoma with FGFR2 Fusion or Other RearrangementSeptember 23, 2026 FDA Approves Inluriyo (imlunestrant) in Combination with Verzenio (abemaciclib) for Adults with ER+, HER2-, ESR1-Mutated Advanced or Metastatic Breast CancerSeptember 18, 2026 IntraBio Announces U.S. FDA Approval of Aqneursa (levacetylleucine) for Ataxia-TelangiectasiaSeptember 18, 2026 FDA Approves Fayuvi (rebisufligene etisparvovec-hopf) Gene Therapy for the Treatment for Sanfilippo Syndrome Type A (MPS IIIA)September 17, 2026 Bayer’s Kerendia (finerenone) Receives FDA Approval as the First New Treatment in 30 Years for Adults with Chronic Kidney Disease (CKD) and Type 1 DiabetesSeptember 17, 2026 Nuvation Bio Announces FDA Approval of Supplemental New Drug Application for Ibtrozi (taletrectinib) with Updated Duration of Response in TKI-Naïve Advanced ROS1-Positive Non-Small Cell Lung CancerSeptember 16, 2026 FDA Approves Reduced Monitoring Time for First Two Doses of ImdelltraSeptember 14, 2026 Biofrontera Announces FDA Approval of Ameluz Red Light PDT for the Treatment of Superficial Basal Cell CarcinomaSeptember 14, 2026 FDA Approves Bexlutry (lutetium Lu 177 dotatate) for Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine TumorsSeptember 13, 2026 FDA Approves Pixclara (floretyrosine F 18) FET-PET Imaging Agent for GliomaSeptember 13, 2026 Drugs.com – New Drug Applications 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 Kowa Pharmaceuticals America Announces FDA Acceptance of New Drug Application for K-911August 26, 2026 Capricor Therapeutics Announces Extension of PDUFA Target Action Date as FDA Continues Review of Deramiocel BLAAugust 24, 2026 United Therapeutics Corporation Announces FDA Filing Acceptance of New Drug Application for Ralinepag to Treat Pulmonary Arterial HypertensionAugust 24, 2026 Drugs.com – Clinical Trials News Modified HIV Drug Reverses Vision Loss and Paralysis in Multiple Sclerosis ModelSeptember 22, 2026 Vistagen Announces Preliminary Positive Data from Open-Label Extension Portion of PALISADE-4 Phase 3 Study of Fasedienol for the Acute Treatment of Social Anxiety DisorderSeptember 22, 2026 Celldex Announces Positive Results from Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Studies of Barzolvolimab Which Met Primary and All Key Secondary EndpointsSeptember 22, 2026 Otsuka Announces Transformative Phase 3 FUSION Results for Ulefnersen, Bringing the FUS-ALS Community Closer to a Potential Targeted TreatmentSeptember 22, 2026 Amgen Announces Positive Topline Phase 3 Results for Dazodalibep in Moderate-to-Severe Systemic Sjögren's DiseaseSeptember 22, 2026 Positive Interim Data Shows Genentech’s Sefaxersen Significantly Reduces Proteinuria in People With IgA Nephropathy (IgAN)September 21, 2026 Compass Therapeutics Provides Regulatory Update on Tovecimig in Biliary Tract Cancer Following FDA FeedbackSeptember 21, 2026 Novo's CagriSema Delivers Superior Weight Loss Versus Tirzepatide in REIMAGINE 5 TrialSeptember 21, 2026 Genentech Announces Positive Phase II Results for Dual GLP-1/GIP Receptor Agonist Enicepatide in People Living With Type 2 Diabetes and Overweight or ObesitySeptember 21, 2026 Abbisko Therapeutics Announces Positive Preliminary Phase 2 Results with Lavengratinib (ABSK061) for the Treatment of AchondroplasiaSeptember 20, 2026
