Industry News Drugs.com – New Drug Approvals FDA Approves Lenmeldy (atidarsagene autotemcel) for Children with Metachromatic LeukodystrophyMarch 18, 2024 Xhance Approved by FDA as First and Only Medication Indicated for Treatment of Adults with Chronic Rhinosinusitis without Nasal PolypsMarch 15, 2024 FDA Grants Accelerated Approval for Rezdiffra (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH)March 14, 2024 FDA Approves Tevimbra (tislelizumab-jsgr) for the Treatment of Advanced or Metastatic Esophageal Squamous Cell CarcinomaMarch 14, 2024 U.S. FDA Approves Bristol Myers Squibb’s Breyanzi as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)March 14, 2024 Mirum Pharmaceuticals’ Livmarli Receives FDA Approval for Treatment of Cholestatic Pruritus in Patients with Progressive Familial Intrahepatic CholestasisMarch 13, 2024 Praluent (alirocumab) Injection Receives FDA Approval to Treat Children with Genetic Form of High CholesterolMarch 11, 2024 Wegovy Approved in the US for Cardiovascular Risk Reduction in People with Overweight or Obesity and Established Cardiovascular DiseaseMarch 8, 2024 FDA Approves Tyenne (tocilizumab-aazg), a Biosimilar to ActemraMarch 7, 2024 BeiGene Announces FDA Accelerated Approval of Brukinsa for the Treatment of Relapsed or Refractory Follicular LymphomaMarch 7, 2024 Drugs.com – New Drug Applications Lumicell Announces FDA Advisory Committee’s Positive Recommendation on the Benefit-Risk Profile of Lumisight in the Detection of Cancerous Tissue During Breast Conserving SurgeryMarch 6, 2024 Zevra Therapeutics Provides FDA Update On The PDUFA Action Date For Arimoclomol As A Treatment For Niemann-Pick Disease Type CMarch 4, 2024 Applied Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Govorestat for the Treatment of Classic GalactosemiaFebruary 28, 2024 Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with SchizophreniaFebruary 27, 2024 BeiGene’s Biologics License Application for Tevimbra (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDAFebruary 27, 2024 Venatorx and Melinta Provide Update on Status of U.S. New Drug Application for Cefepime-TaniborbactamFebruary 23, 2024 Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority ReviewFebruary 21, 2024 FDA and EMA Accept Vorasidenib Regulatory Submissions for the Treatment of IDH-mutant diffuse gliomaFebruary 20, 2024 Datopotamab Deruxtecan Biologics License Application Accepted in the US for Patients with Previously Treated Advanced Nonsquamous Non-Small Cell Lung CancerFebruary 19, 2024 Galderma Announces Regulatory Filing Acceptance for Nemolizumab in Prurigo Nodularis and Atopic Dermatitis in the U.S. and EUFebruary 14, 2024 Drugs.com – Clinical Trials News Positive Results from Phase 3 BouNDless Trial of Investigational ND0612 in People with Parkinson's Disease Experiencing Motor FluctuationMarch 18, 2024 Repurposed Drug Fenoprofen Shows Promise Against Endometriosis-Related Pain in Animal ModelMarch 18, 2024 myTomorrows Partners with The ALS Association to Support ALS Patients in Accessing Clinical TrialsMarch 15, 2024 Geron Announces FDA Oncologic Drugs Advisory Committee Votes in Favor of the Clinical Benefit/Risk Profile of Imetelstat for the Treatment of Transfusion-Dependent Anemia in Patients with Lower-Risk MDSMarch 14, 2024 Keros Therapeutics Announces U.S. FDA Fast Track Designation for KER-050 in Lower-Risk Myelodysplastic SyndromesMarch 14, 2024 Cybin Receives FDA Breakthrough Therapy Designation for its Novel Psychedelic Molecule CYB003 and Announces Positive Four-Month Durability Data in Major Depressive DisorderMarch 13, 2024 FDA Revises Letter of Authorization for the Emergency Use Authorization for PaxlovidMarch 13, 2024 PureTech Receives Orphan Drug Designation for LYT-200 in Acute Myeloid LeukemiaMarch 13, 2024 Silence Therapeutics Announces Positive Topline 36-Week Data from Ongoing Phase 2 Study of Zerlasiran in Patients with High Lipoprotein(a)March 13, 2024 Takeda Announces Positive Topline Results from Phase 2 Study Evaluating Mezagitamab (TAK-079), a Potential Best-in-Class Anti-CD38 Monoclonal Antibody, for Primary Immune ThrombocytopeniaMarch 13, 2024