Vertex expands CASGEVY to young children with sickle cell disease and beta thalassemia
Explore how the FDA’s CASGEVY age expansion could reshape early gene therapy for sickle cell disease and beta thalassemia. Read more.
Pharma & Biotech
Pharma & Biotech
Galderma’s relabotulinumtoxinA FDA setback shifts attention to manufacturing readiness
Discover why FDA manufacturing concerns have delayed Galderma’s relabotulinumtoxinA approval and what the company must resolve next.
Pharma & Biotech
Apotex Sevmia challenges Wegovy as generic GLP-1 competition begins in Canada
Read how Apotex’s Sevmia approval could reshape Canada’s semaglutide market, and why dosing, pricing and reimbursement still matter.
Pharma & Biotech
Shantha Biologics wins high-stakes Novo Nordisk fill-finish mandate in Hyderabad
Read how Shantha Biologics’ Novo Nordisk cartridge fill-finish deal could reshape complex injectable manufacturing in India.
Pharma & Biotech
Contineum Therapeutics paper sharpens PIPE-791 case, but Phase 2 IPF data remain decisive
Discover why Contineum Therapeutics’ PIPE-791 paper strengthens the LPAR1 case while Phase 2 IPF data remain the decisive clinical test.
Pharma & Biotech
Lilly advances TRB-051 in lupus as TRexBio unveils the mechanism behind TRB-071
Explore how TRexBio’s TRB-071 CD30 agonist and Lilly-partnered TRB-051 could reshape tissue Treg drug development. Read the analysis.
Pharma & Biotech
Cellares enters FDA PreCheck as Cell Shuttle moves from automation promise to regulatory proof
Find out how Cellares’ FDA PreCheck selection could reshape automated cell therapy manufacturing while leaving product approval risks intact.
Pharma & Biotech
Orca Bio’s TREGZI enters the transplant market with a strong Phase 3 advantage
See how Orca Bio’s TREGZI FDA approval could reshape blood cancer transplants, reduce chronic GVHD and test cell therapy scale-up.
Medical Devices & Diagnostics
SC Therapeutics launches REACH2 as SC0032 targets chronic cough beyond symptom control
SC Therapeutics is advancing an unconventional soft-mist spray into a more rigorous UK study designed to test objective cough reduction, durability and the limits of an upstream airway-focused mechanism.
Medical Devices & Diagnostics
Is RefleXion about to unlock a larger SCINTIX market with Anchor Point Tracking?
RefleXion Medical’s FDA filing for Anchor Point Tracking could extend the reach of SCINTIX autonomous radiotherapy, but clinical evidence and workflow economics remain critical.