Industry News Drugs.com – New Drug Approvals U.S. FDA Approves Pfizer’s RSV Vaccine Abrysvo for Adults Aged 18 to 59 at Increased Risk for DiseaseOctober 22, 2024 FDA Approves Vyloy (zolbetuximab-clzb) for the Treatment of Advanced Gastric and GEJ CancerOctober 21, 2024 Botox Cosmetic (onabotulinumtoxinA) Receives FDA Approval for Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands)October 18, 2024 FDA Approves Vyalev (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's DiseaseOctober 17, 2024 Avadel Pharmaceuticals Announces FDA Approval of Lumryz (sodium oxybate) Extended-Release Oral Suspension (CIII) for the Treatment of Cataplexy or Excessive Daytime Sleepiness in Patients 7 Years of Age and Older with NarcolepsyOctober 17, 2024 UCB Receives U.S. FDA Approval for 320 mg Single-Injection Device Presentations of Bimzelx (bimekizumab-bkzx)October 14, 2024 FDA Approves Imuldosa (ustekinumab-srlf), a Biosimilar to StelaraOctober 14, 2024 FDA Approves Hympavzi (marstacimab-hncq) for the Treatment of Adults and Adolescents with Hemophilia A or B Without InhibitorsOctober 11, 2024 FDA Approves Itovebi (inavolisib) for the Combination Treatment of Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA MutationOctober 10, 2024 U.S. Food and Drug Administration Approves Perioperative Treatment of Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Surgery and Adjuvant Single-Agent Opdivo for Resectable Non-Small Cell Lung Cancer (NSCLC)October 3, 2024 Drugs.com – New Drug Applications Camurus Provides Regulatory Update on the US NDA for CAM2029 in AcromegalyOctober 22, 2024 Tonix Pharmaceuticals Announces Submission of the TNX-102 SL New Drug Application (NDA) for Fibromyalgia to the U.S. Food and Drug Administration (FDA)October 16, 2024 Stealth BioTherapeutics Announces Positive Vote from FDA Advisory Committee Meeting Supporting Potential Approval of Elamipretide for the Treatment of Barth SyndromeOctober 11, 2024 U.S. Food and Drug Administration (FDA) Accepts New Drug Application for ElinzanetantOctober 9, 2024 Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye DiseaseOctober 3, 2024 Elevar Therapeutics Resubmits New Drug Application to FDA for Combination of Camrelizumab plus Rivoceranib as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma Boosted by CARES-310 Leading Overall Survival AnalysisSeptember 23, 2024 FDA Declines to Approve Vanda's Marketing Application for Tradipitant in GastroparesisSeptember 19, 2024 Iterum Therapeutics Provides Update on FDA Advisory Committee Discussion of Oral Sulopenem for the Treatment of uUTI in Adult WomenSeptember 10, 2024 Axsome Therapeutics Announces FDA Acceptance of NDA Resubmission for AXS-07 for the Acute Treatment of MigraineSeptember 4, 2024 KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary AngioedemaSeptember 3, 2024 Drugs.com – Clinical Trials News FDA Grants Rare Pediatric Disease Designation to Omeros’ MASP-3 Inhibitor Zaltenibart for Treatment of C3 GlomerulopathyOctober 24, 2024 NIH Clinical Trial Will Test Precision Medicine Treatments for Myeloid CancersOctober 23, 2024 First participants enrolled in first-in-human Phase I clinical trial with nociceptin (NOP) receptor agonistOctober 22, 2024 Sangamo Therapeutics Announces Alignment With FDA on Accelerated Approval Pathway for ST-920 in Fabry Disease With BLA Submission Expected in 2025October 22, 2024 Alto Neuroscience Reports Topline Results from a Phase 2b Trial Evaluating ALTO-100 as a Treatment for Major Depressive DisorderOctober 22, 2024 Darling Ingredients Announces Publication of Peer-Reviewed Collagen Peptides Study and its Impact on Post-Meal Blood Glucose SpikesOctober 22, 2024 Phase 2 study demonstrates the first successful clinical application of antifibrotic therapy for breast cancerOctober 20, 2024 Nurix Therapeutics Presents Positive Results from the Ongoing Clinical Trial of Its BTK Degrader NX-5948 in Patients with Relapsed/Refractory Waldenstrom’s MacroglobulinemiaOctober 19, 2024 Gilead and Merck Announce Phase 2 Data Showing a Treatment Switch to an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression in Adults at Week 48October 19, 2024 Amylyx Pharmaceuticals Announces Positive Topline Results from Phase 2 HELIOS Clinical Trial Demonstrating Sustained Improvements with AMX0035 in People Living with Wolfram SyndromeOctober 17, 2024