Industry News Drugs.com – New Drug Approvals FDA Approves Leqselvi (deuruxolitinib), an Oral JAK Inhibitor for the Treatment of Severe Alopecia AreataJuly 26, 2024 FDA Approves Femlyv (norethindrone acetate and ethinyl estradiol) Orally Disintegrating Birth Control PillJuly 23, 2024 Merz Aesthetics Announces FDA Approval of Xeomin (incobotulinumtoxinA) as the First and Only U.S. Neurotoxin for the Simultaneous Treatment of Upper Facial LinesJuly 23, 2024 FDA Approves Epysqli (eculizumab-aagh), a Biosimilar to SolirisJuly 22, 2024 FDA Approves Zituvimet XR (sitagliptin and metformin hydrochloride) Extended-Release Tablets for Adults with Type 2 DiabetesJuly 19, 2024 Phathom Pharmaceuticals Announces FDA Approval of Voquezna (vonoprazan) Tablets for the Relief of Heartburn Associated with Non-Erosive GERD in AdultsJuly 18, 2024 FDA Approves Arcutis’ Zoryve (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of AgeJuly 9, 2024 FDA Approves Genentech’s Vabysmo Prefilled Syringe (PFS) for Three Leading Causes of Vision LossJuly 4, 2024 FDA Approves Kisunla (donanemab-azbt) for the Treatment of Early Symptomatic Alzheimer's DiseaseJuly 2, 2024 FDA Approves Ahzantive (aflibercept-mrbb), a Biosimilar to EyleaJuly 1, 2024 Drugs.com – New Drug Applications Atara Biotherapeutics Announces U.S. FDA Acceptance and Priority Review of the Biologics License Application for Tabelecleucel (Tab-cel®) for the Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative DiseaseJuly 17, 2024 Orexo Receives a Complete Response Letter Regarding the NDA for OX124, a High-Dose Naloxone Rescue Medication in Development for Opioid OverdoseJuly 17, 2024 Lexicon Pharmaceuticals Receives December 20, 2024 PDUFA Goal Date for Sotagliflozin Type 1 Diabetes NDA ResubmissionJuly 16, 2024 Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-400 (Hydrocortisone Oral Solution)July 15, 2024 Vertex Announces FDA Acceptance of New Drug Application for Vanzacaftor/Tezacaftor/Deutivacaftor, a Next-In-Class Triple Combination Treatment for Cystic FibrosisJuly 2, 2024 SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PNJuly 1, 2024 Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party ManufacturerJune 26, 2024 AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa)June 25, 2024 Lexicon Pharmaceuticals Resubmits Sotagliflozin NDA for Type 1 DiabetesJune 21, 2024 KalVista Submits New Drug Application to FDA for Sebetralstat as First Oral On-Demand Treatment for Hereditary AngioedemaJune 18, 2024 Drugs.com – Clinical Trials News Presage Biosciences Announces First Patient Dosing of Pure Biologics' ROR1 Targeting Antibody For Treatment of CancerJuly 26, 2024 Final Results from a Phase 2 Study of TPN-101 for the Treatment of C9orf72-Related Amyotrophic Lateral Sclerosis and/or Frontotemporal DementiaJuly 24, 2024 Vivacelle Bio Initiates Phase 3 Trial for Lead Asset VBI-S to Treat Patients with Hypovolemia Due to Septic ShockJuly 24, 2024 An Isolated Viral Load Test May Generate False Positive Results for People Using Long-Acting PrEPJuly 23, 2024 Long-Acting Injectable Cabotegravir for HIV Prevention is Safe in PregnancyJuly 23, 2024 Merck Announces Topline Results from Phase 2b/3 Trial of Clesrovimab (MK-1654), an Investigational Respiratory Syncytial Virus Preventative Monoclonal Antibody for InfantsJuly 23, 2024 ViiV Healthcare Premieres Early Data Showing Antiviral Activity Against Integrase Resistance from its Investigational, Third-Generation Integrase Inhibitor VH184July 23, 2024 Exploratory Analysis Associates HIV Drug Abacavir with Elevated Cardiovascular Disease Risk in Large Global TrialJuly 23, 2024 TCBP Announces Dosing of 6th Patient in ACHIEVE Study in Patients with Acute Myeloid LeukemiaJuly 22, 2024 Ionis completes enrollment in pivotal trial evaluating zilganersen in people living with Alexander diseaseJuly 18, 2024