Novo Nordisk Lowers 2025 Sales and Profit Outlook
Novo Nordisk has revised its 2025 sales and operating profit growth outlook downwards, now projecting 8-14% and 10-16% growth...
Jon Napitupulu
Duravyu™ Phase 3 Trials for Wet AMD Conclude Enrollment
EyePoint Pharmaceuticals has completed enrollment in its Phase 3 LUCIA trial for Duravyu, a sustained-release tyrosine kinase inhibitor (TKI)...
Pharmazz Inc. Starts Phase 3 Sovateltide Trial for Stroke
Pharmazz Initiates Pivotal Phase 3 Trial for Sovateltide in Ischemic Stroke Pharmazz has dosed the first patient in its...
Serina Therapeutics to Develop Novel TD Treatment
Serina Therapeutics is advancing SER-270 (POZ-VMAT2i), a once-weekly injectable vesicular monoamine transporter 2 (VMAT2) inhibitor, for tardive dyskinesia (TD)....
LIFT Biosciences Awarded €12M Grant for First-in-Human Trial
Lift Biosciences Secures €12M Grant to Advance First-in-Human Trials of Novel Neutrophil Immunotherapy Lift Biosciences has been awarded a...
FDA Approves Doptelet for Thrombocytopenia in Children
Sobi North America has secured FDA approval for Doptelet (avatrombopag) to treat thrombocytopenia in pediatric patients aged one year...
Elevidys™ Gene Therapy for Duchenne Muscular Dystrophy: EU Regulatory Update
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has delivered a negative opinion on Roche’s...
Alhemo® Approval for Haemophilia A&B (No Inhibitors)
Novo Nordisk has secured a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use...
Pfizer, BioNTech Get CHMP Nod for Adapted COVID-19 Vaccine in EU
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Pfizer...
Sarclisa® Approved in EU for Newly Diagnosed Multiple Myeloma
The European Commission has granted approval for Sanofi’s Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) as...