Approved
FDA Issues Draft Guidance on MRD and CR Endpoints for Accelerated Multiple Myeloma Drug Approvals
FDA guidance; multiple myeloma; MRD; complete response; accelerated approval
IntraBio’s Levacetylleucine Succeeds in Phase 3 Trial for Ataxia-Telangiectasia, Plans FDA and EMA Approval
IntraBio; levacetylleucine; Ataxia-Telangiectasia; Phase 3; FDA approval; EMA; rare disease
Teva Launches First Generic GLP-1 for Weight Loss Amid Ongoing Market Developments
generic GLP-1; Teva; liraglutide; Saxenda; FDA approval; weight loss drugs
Sentynl Therapeutics Receives FDA Approval for ZYCUBO, First US Treatment for Rare Menkes Disease
Sentynl Therapeutics; ZYCUBO; FDA approval; Menkes disease; copper histidinate; Zydus Lifesciences
Alumis’ TYK2 Inhibitor Envudeucitinib Succeeds in Phase 3 Psoriasis Trials, Plans FDA Filing
Alumis; envudeucitinib; TYK2 inhibitor; psoriasis; Phase 3 trials; FDA approval; PASI 75
ScinoPharm Taiwan Secures Historic U.S. FDA Approval for Glatiramer Acetate Injection to Treat Multiple Sclerosis
ScinoPharm; FDA Approval; Glatiramer Acetate; Multiple Sclerosis; Taiwan; Complex Generic
Vanda Pharmaceuticals Secures FDA Approval for NEREUS (Tradipitant), First New Motion Sickness Drug in Over 40 Years
Vanda Pharmaceuticals; FDA approval; NEREUS; tradipitant; motion sickness; vomiting prevention
Agios Pharmaceuticals Secures FDA Approval for Aqvesme (Mitapivat) in Thalassemia Treatment
Agios Pharmaceuticals; FDA approval; thalassemia; Aqvesme; mitapivat; anemia
Novo Nordisk Wins FDA Approval for First Oral GLP-1 Wegovy Pill in Obesity Treatment
Novo Nordisk; Wegovy pill; FDA approval; oral semaglutide; obesity treatment; GLP-1
FDA Approves Novo Nordisk’s Wegovy Pill as First Oral GLP-1 for Weight Management
Novo Nordisk; Wegovy pill; FDA approval; obesity treatment; oral semaglutide