Industry News Drugs.com – New Drug Approvals FDA Approves Likmez (metronidazole) Oral Suspension for the Treatment of Parasitic and Anaerobic Bacterial InfectionsSeptember 25, 2023 US FDA Approves Jardiance for the Treatment of Adults with Chronic Kidney DiseaseSeptember 22, 2023 FDA Approves Ojjaara (momelotinib) for Myelofibrosis Patients with AnemiaSeptember 15, 2023 FDA Approves New and Updated Indications for Temozolomide Under Project RenewalSeptember 14, 2023 FDA Approves Aphexda (motixafortide) to Mobilize Hematopoietic Stem Cells for Autologous Transplantation in Patients with Multiple MyelomaSeptember 11, 2023 Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 VaccineSeptember 11, 2023 Moderna Receives U.S. FDA Approval for Updated COVID-19 VaccineSeptember 11, 2023 U.S. FDA Approves Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) as First-Line Treatment of Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS) Who May Require TransfusionsAugust 28, 2023 FDA Approves Veklury (remdesivir) to Treat COVID-19 in People With Mild to Severe Hepatic Impairment With no Dose AdjustmentAugust 24, 2023 FDA Approves Tyruko (natalizumab-sztn), a Biosimilar to TysabriAugust 24, 2023 Drugs.com – New Drug Applications FDA Accepts Submission to Add PH-ILD to Yutrepia™ LabelSeptember 25, 2023 Takeda Announces FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Treatment of Eosinophilic Esophagitis (EoE)September 20, 2023 UCB Provides Update on U.S. Regulatory Review of BimekizumabSeptember 19, 2023 FDA Issues Complete Response Letter for neffy® (epinephrine nasal spray) New Drug Application with Request for Additional StudySeptember 19, 2023 Orchard Therapeutics Announces Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority ReviewSeptember 18, 2023 Madrigal Pharmaceuticals Announces NDA Acceptance and Priority Review of the New Drug Application for Resmetirom for the Treatment of NASH with Liver FibrosisSeptember 13, 2023 Day One Announces Updated FIREFLY-1 Data for Tovorafenib and Completion of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)September 11, 2023 Verona Pharma Announces the US FDA has Accepted the New Drug Application Filing for Ensifentrine for the Maintenance Treatment of COPDSeptember 11, 2023 Aquestive Therapeutics Receives FDA Acceptance Of New Drug Application (NDA) For Libervant (Diazepam) Buccal Film In Pediatric Patients And Assignment Of Prescription Drug User Fee Act (PDUFA) DateSeptember 11, 2023 X4 Pharmaceuticals Announces Submission of New Drug Application (NDA) to U.S. FDA for Mavorixafor in WHIM SyndromeSeptember 5, 2023 Drugs.com – Clinical Trials News NMD Pharma initiates Phase II trial of NMD670 in Spinal Muscular AtrophySeptember 26, 2023 Reviva Announces Last Patient Evaluated in Pivotal Phase 3 RECOVER Trial for Brilaroxazine in SchizophreniaSeptember 25, 2023 Datopotamab Deruxtecan Demonstrated Statistically Significant and Clinically Meaningful Progression-Free Survival Benefit in Patients with HR-Positive, HER2-Low or Negative Breast Cancer in TROPION-Breast01 Phase III TrialSeptember 22, 2023 Clinical Trial to Test Immune Modulation Strategy for Hospitalized Covid-19 Patients BeginsSeptember 22, 2023 Puma Biotechnology Receives FDA Orphan Drug Designation for Alisertib for the Treatment of Small Cell Lung CancerSeptember 21, 2023 Leucid Bio Granted MHRA Clinical Trial Authorisation for Lateral NKG2D CAR-T Cell Therapy LEU011September 21, 2023 U.S. Food and Drug Administration Approves Orphan Drug Designation for Immix Biopharma NXC-201 as a Treatment for Amyloid Light Chain (AL) AmyloidosisSeptember 21, 2023 Disc Medicine Receives FDA Fast Track Designation for MWTX-003 for the Treatment of Polycythemia VeraSeptember 20, 2023 Relmada Therapeutics Announces Efficacy and Safety Results from the Phase 3 Long-Term Study of REL-1017 in Major Depressive DisorderSeptember 20, 2023 Researchers Develop New Method to Identify Potential Stroke TherapiesSeptember 20, 2023
