Industry News Drugs.com – New Drug Approvals FDA Approves Tregzi (Orca-T) as First and Only Precision-Engineered Cell Therapy for Allogeneic Transplant in Adults with Hematological MalignanciesJune 30, 2026 FDA Approves Arcutis’ Zoryve (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children as Young as Age 2June 29, 2026 FDA Approves Lumvoa (veligrotug-vvze) for the Treatment of Thyroid Eye DiseaseJune 26, 2026 Skyrizi (risankizumab-rzaa) Now FDA Approved for Pediatric Use in Psoriatic DiseaseJune 25, 2026 FDA Approves Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each with Trodelvy (sacituzumab govitecan-hziy) as First-Line Treatment of PD-L1+ (CPS ≥10) Advanced Triple-Negative Breast Cancer (TNBC)June 24, 2026 Tryngolza (olezarsen) Approved to Reduce Triglycerides and the Risk of Acute Pancreatitis in Patients with Severe HypertriglyceridemiaJune 24, 2026 U.S. FDA Approves Trodelvy for First-Line Treatment of Metastatic Triple-Negative Breast CancerJune 24, 2026 FDA Approves Pfizer’s Ibrance Regimen for HR+, HER2+ Metastatic Breast Cancer Frontline MaintenanceJune 23, 2026 FDA Approves Rextovy (naloxone hydrochloride) Nasal Spray for Over-the-Counter UseJune 20, 2026 U.S. FDA Approves an Additional Indication for Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) in Children and Adolescents Aged 2 through 17 at Increased Risk for Pneumococcal DiseaseJune 17, 2026 Drugs.com – New Drug Applications Vertex Announces US FDA Acceptance of Biologics License Application for Accelerated Approval of Povetacicept in IgA NephropathyJune 1, 2026 FDA Accepts New Drug Application for Genentech’s Giredestrant in ER-Positive Early-Stage Breast Cancer, the First and Only Oral SERD With Positive Phase III Results in the Curative SettingMay 31, 2026 Zenas BioPharma Announces Submission of Biologics License Application (BLA) to U.S. FDA for Obexelimab in IgG4-RDMay 28, 2026 Zydus Therapeutics New Drug Application (NDA) for Saroglitazar to Treat Primary Biliary Cholangitis (PBC) Granted Priority Review by the US FDAMay 28, 2026 Cogent Biosciences Announces FDA Acceptance of New Drug Application (NDA) with Priority Review for Bezuclastinib in Combination with Sunitinib for Patients with GISTMay 28, 2026 BridgeBio Announces FDA Acceptance and Priority Review of NDA for BBP-418 for LGMD2I/R9May 27, 2026 Dyne Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA for Z-Rostudirsen in Exon 51 Duchenne Muscular Dystrophy (DMD)May 26, 2026 New Drug Application for Bayer’s FXIa Inhibitor Asundexian Accepted by U.S. Food and Drug Administration Under Priority ReviewMay 19, 2026 U.S. FDA Grants Priority Review of New Drug Application for Gilead’s Once-Daily HIV Treatment of Bictegravir Plus LenacapavirApril 29, 2026 Immunome Announces Submission of New Drug Application to U.S. FDA for Varegacestat for the Treatment of Adults with Desmoid TumorsApril 28, 2026 Drugs.com – Clinical Trials News 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 Pfizer Announces Topline Phase 3 Results for Sigvotatug Vedotin in Previously Treated Metastatic Non-Squamous Non-Small Cell Lung CancerJune 22, 2026 New Analyses from FIBRONEER™ Trials Suggest Survival Benefit with Nerandomilast in IPF and PPFJune 18, 2026 For Adults with Prediabetes, Lifestyle Intervention Lowered Risk of Developing Multiple Chronic ConditionsJune 15, 2026 New Pivotal Study Data Show Takeda’s Oveporexton Improved Daily Function, Cognition and Nighttime Sleep for People with Narcolepsy Type 1June 15, 2026 Novartis Delpacibart Braxlosiran (del-brax) Phase I/II Study in Facioscapulohumeral Muscular Dystrophy (FSHD) Meets Primary Biomarker EndpointJune 11, 2026 Takeda’s Zasocitinib Significantly Outperforms Deucravacitinib in Head-to-Head Phase 3 Psoriasis Study, Promising to Redefine Oral Treatment ExpectationsJune 11, 2026 Matisse Pharmaceuticals Receives FDA Fast Track Designation for Isupartob Sodium in SepsisJune 8, 2026 Elecoglipron, an Oral Small Molecule GLP-1 RA, Moves to Phase III ProgrammeJune 7, 2026
