Industry News Drugs.com – New Drug Approvals FDA Approves Pivya (pivmecillinam) for the Treatment of Uncomplicated Urinary Tract InfectionsApril 24, 2024 FDA Grants Accelerated Approval for Ojemda (tovorafenib) for Relapsed or Refractory BRAF-altered Pediatric Low-Grade GliomaApril 23, 2024 FDA Approves Anktiva (nogapendekin alfa inbakicept-pmln) Plus BCG for BCG-Unresponsive Non-Muscle Invasive Bladder CancerApril 22, 2024 U.S. FDA Approves Subcutaneous Administration of Takeda’s Entyvio (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s DiseaseApril 18, 2024 FDA Approves Lumisight (pegulicianine) Optical Imaging Agent to Illuminate Residual Breast Cancer Post-LumpectomyApril 18, 2024 FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung CancerApril 18, 2024 FDA Approves Selarsdi (ustekinumab-aekn), a Biosimilar to StelaraApril 16, 2024 Fasenra Approved for Treatment of Children Aged 6 to 11 with Severe AsthmaApril 11, 2024 Xcopri (cenobamate) Receives FDA Approval for Alternate Methods of Administration That Include Crushed Tablet in Liquid Suspension Taken Orally or Through a Nasogastric TubeApril 11, 2024 ViiV Healthcare Announces U.S. FDA Approval of Dovato (dolutegravir/lamivudine) for Adolescents Living with HIVApril 8, 2024 Drugs.com – New Drug Applications Abeona Therapeutics Provides Regulatory Update on Pz-celApril 22, 2024 Supernus Provides Regulatory Update for SPN-830April 8, 2024 Stealth Biotherapeutics Announces FDA Acceptance of New Drug Application for Elamipretide for the Treatment of Barth SyndromeApril 8, 2024 Jazz Pharmaceuticals Completes Zanidatamab Biologics License Application for Previously Treated HER2-Positive Metastatic Biliary Tract CancerApril 2, 2024 Datopotamab Deruxtecan Biologics License Application Accepted in the US for Patients with Previously Treated Metastatic HR-Positive, HER2-Negative Breast CancerApril 2, 2024 Milestone Pharmaceuticals Announces Resubmission of New Drug Application for Etripamil for Treatment in Paroxysmal Supraventricular TachycardiaMarch 28, 2024 Aldeyra Therapeutics Announces Clinical Development Plan for Resubmission of New Drug Application for Reproxalap in Dry Eye DiseaseMarch 28, 2024 Applied Therapeutics Provides FDA Update on PDUFA Target Action Date for Govorestat for the Treatment of Classic GalactosemiaMarch 28, 2024 Syndax Announces FDA Priority Review of NDA for Revumenib for the Treatment of Relapsed/Refractory KMT2Ar Acute LeukemiaMarch 26, 2024 IntraBio Announces U.S. FDA Accepts New Drug Application for IB1001 for the Treatment of Niemann-Pick Disease Type CMarch 26, 2024 Drugs.com – Clinical Trials News Clinical Study Identifies Personalized Treatment Options for Metastatic Non-Small Cell Lung Cancer With Plasma Proteome TestingApril 25, 2024 Gene-Based Therapy Restores Cellular Development and Function in Brain Cells From People With Timothy SyndromeApril 24, 2024 Lykos Therapeutics Announces Completion of European Phase 2 Study for MDMA-Assisted Therapy for PTSDApril 24, 2024 Endevica Bio drug candidate shows success in weight loss in new studyApril 23, 2024 FDA Approves Clinical Trial for GFH925 Monotherapy in Phase III Registrational Study Treating Metastatic Colorectal CancerApril 22, 2024 Doctors Underutilize Next-Gen Antibiotics to Fight Resistant Infections in U.S. HospitalsApril 19, 2024 AskBio Receives FDA Fast Track Designation for AB-1002 Investigational Gene Therapy Program in Congestive Heart FailureApril 18, 2024 NIH Researchers Develop AI Tool with Potential to More Precisely Match Cancer Drugs to PatientsApril 18, 2024 Vertex Announces Advancements of Suzetrigine (VX-548) in Acute and Neuropathic PainApril 18, 2024 BiVictriX Announces FDA Orphan Drug Designation and Completion of FDA INTERACT Meeting for BVX001 in the Treatment of Acute Myeloid LeukemiaApril 17, 2024