Industry News Drugs.com – New Drug Approvals FDA Approves Sephience (sepiapterin) for the Treatment of Children and Adults Living with PhenylketonuriaJuly 28, 2025 FDA Approves Skytrofa (lonapegsomatropin-tcgd) for the Once-Weekly Treatment of Adults with Growth Hormone DeficiencyJuly 28, 2025 FDA Approves Apellis’ Empaveli (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and OlderJuly 28, 2025 Sobi Announces U.S. Food and Drug Administration Approves Doptelet (avatrombopag) for the Treatment of Thrombocytopenia in Pediatric Patients One Year and Older with Persistent or Chronic Immune Thrombocytopenia (ITP)July 25, 2025 FDA Approves Anzupgo (delgocitinib) Cream for the Treatment of Chronic Hand EczemaJuly 23, 2025 Spritam (levetiracetam) Tablets for Oral Suspension Approved by FDA for Nasogastric and Gastrostomy Tube AdministrationJuly 22, 2025 US FDA Approves GSK’s Shingrix in a Prefilled Syringe PresentationJuly 17, 2025 FDA Approves Kirsty (insulin aspart-xjhz), an Interchangeable Biosimilar to NovoLogJuly 15, 2025 U.S. FDA Approves Kerendia (finerenone) to Treat Patients with Heart Failure with Left Ventricular Ejection Fraction ≥40% Following Priority ReviewJuly 14, 2025 Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine, Spikevax in Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 DiseaseJuly 10, 2025 Drugs.com – New Drug Applications Pierre Fabre Pharmaceuticals Inc. Announces FDA Acceptance and Priority Review of the Biologics License Application (BLA) for Tabelecleucel for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD)July 24, 2025 Replimune Receives Complete Response Letter from FDA for RP1 Biologics License Application for the Treatment of Advanced MelanomaJuly 22, 2025 Johnson & Johnson Seeks First Icotrokinra U.S. FDA Approval Aiming to Revolutionize Treatment Paradigm for Adults and Adolescents with Plaque PsoriasisJuly 21, 2025 Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye DiseaseJuly 17, 2025 Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian CancerJuly 14, 2025 Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular DystrophyJuly 11, 2025 Unicycive Therapeutics Announces Receipt of Complete Response Letter for Oxylanthanum Carbonate for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on DialysisJune 30, 2025 Achieve Life Sciences Announces Submission of NDA to FDA for Cytisinicline as a Treatment of Nicotine Dependence for Smoking CessationJune 26, 2025 Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye DiseaseJune 17, 2025 KalVista Pharmaceuticals Announces FDA Will Not Meet PDUFA Goal Date for Sebetralstat NDA for Hereditary Angioedema Due to FDA Resource ConstraintsJune 13, 2025 Drugs.com – Clinical Trials News Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to MenopauseJuly 25, 2025 Gefurulimab Dual-Binding Nanobody Demonstrated Statistically Significant and Clinically Meaningful Improvement in Functional Activities of Daily Living in Adults with Generalised Myasthenia Gravis in PREVAIL Phase III TrialJuly 24, 2025 Verastem Oncology Granted Fast Track Designation for VS-7375 for the Treatment of KRAS G12D-mutated Locally Advanced or Metastatic Pancreatic CancerJuly 24, 2025 Avidity Biosciences Receives FDA Breakthrough Therapy Designation for Delpacibart Zotadirsen (del-zota) for the Treatment of DMD in People with Mutations Amenable to Exon 44 SkippingJuly 23, 2025 Revolution Medicines Announces FDA Breakthrough Therapy Designation for ElironrasibJuly 23, 2025 Apnimed Reports Positive Topline Results from Second Phase 3 Trial of AD109, Reinforcing Potential of First Oral Pill for Obstructive Sleep ApneaJuly 23, 2025 Abivax Announces Positive Phase 3 Results from Both ABTECT 8-Week Induction Trials Investigating Obefazimod, its First-in-Class Oral miR-124 Enhancer, in Moderate to Severely Active Ulcerative ColitisJuly 22, 2025 Takeda Receives FDA 510(k) Clearance for HyHub™ and HyHub™ Duo Devices to Simplify Hyqvia AdministrationJuly 21, 2025 Genentech Provides Update on Astegolimab in Chronic Obstructive Pulmonary DiseaseJuly 20, 2025 FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following Three DeathsJuly 18, 2025
