Industry News Drugs.com – New Drug Approvals FDA Approves Lilly's Ebglyss (lebrikizumab-lbkz) for One Maintenance Dose Every Eight Weeks in Patients with Moderate-to-Severe Atopic DermatitisJune 8, 2026 U.S. FDA Approves Pfizer’s Hympavzi for the Treatment of Two Additional Hemophilia A or B Patient Populations with Significant Medical NeedJune 8, 2026 FDA Approves Xocova (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following ExposureJune 1, 2026 FDA Approves Zaynich (cefepime and zidebactam) for the Treatment of Complicated Urinary Tract InfectionsMay 30, 2026 MannKind Announces FDA Approval of Afrezza, the First and Only Inhaled Mealtime Insulin for Use in Children and Adolescents Aged 6 and Older Living with DiabetesMay 29, 2026 Imfinzi Approved in the US in First and Only Immunotherapy Combination for Patients with BCG-Naïve, High-Risk Non-Muscle-Invasive Bladder CancerMay 28, 2026 FDA Approves Label Expansion, Cementing Tremfya as the Only IL‑23 Inhibitor Proven to Help Stop Further Joint DamageMay 27, 2026 FDA Approves Use of Linzess (linaclotide) in Pediatric Patients Two Years of Age and Older with Functional Constipation (FC)May 27, 2026 FDA Approves Decnupaz (pivekimab sunirine-pvzy) for the Treatment of Blastic Plasmacytoid Dendritic Cell NeoplasmMay 27, 2026 FDA Grants Accelerated Approval to Hepcludex (bulevirtide-gmod) Treatment for Chronic Hepatitis Delta Virus (HDV)May 22, 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 Elecoglipron, an Oral Small Molecule GLP-1 RA, Moves to Phase III Programme and Unlocks Next Chapter in AstraZeneca's Cardiometabolic and Kidney PortfolioJune 10, 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 Gilead and Merck Announce Positive Topline Results From Two Phase 3 Studies Evaluating Islatravir/Lenacapavir, an Oral Once-Weekly HIV TreatmentJune 7, 2026 NIH Researchers Identify Regulatory Cells That Shield Against Inflammatory Bowel DiseaseJune 7, 2026 Lilly's Oral GLP-1 Foundayo (orforglipron) Delivered Superior A1C Control and Weight Loss in Three Pivotal Type 2 Diabetes TrialsJune 7, 2026 Novo Nordisk's CagriSema 2.4 mg / 2.4 mg Demonstrated Significant Reduction in HbA1c and Weight Across Multiple Studies in the REIMAGINE ProgramJune 7, 2026 Lilly's Foundayo (orforglipron), the Only Oral GLP-1 Taken Without Food or Water Restrictions, was Associated with Significant Weight Loss in Women at Every Stage of MenopauseJune 7, 2026 Boehringer Ingelheim’s Survodutide Phase III Trial Showed Targeted 34% Visceral and 63% Liver Fat ReductionJune 7, 2026 Lilly's Triple Agonist, Retatrutide, Drove Substantial Improvements in Weight, A1C, Knee Osteoarthritis Pain, and Obstructive Sleep Apnea, Demonstrating its Remarkable Potential to Treat Obesity and its ComplicationsJune 6, 2026
