Rezolute’s Ersodetug Misses Primary Endpoint in Congenital Hyperinsulinism Trial
Rezolute's ersodetug misses primary endpoint in congenital hyperinsulinism trial, though secondary CGM data shows consistent hypoglycemia reductions across anal
FDA Approves Vepdegestrant for ESR1-Mutant Breast Cancer
FDA approves vepdegestrant for ESR1-mutant breast cancer, the first PROTAC protein degrader cleared. Median PFS improved to 5.0 months...
The Protocol Complexity Tax: What Sponsors Don’t See on the Site Invoice
Protocol complexity now drives 76% of trials to at least one amendment—here's what that costs sites in activation days,...
Apotex Gets Health Canada Approval for Generic Semaglutide
Apotex receives Health Canada approval for generic semaglutide injection, matching all commercial formats of Novo Nordisk's Ozempic for type...
BioMarin’s Vosoritide Shows Sustained Height Gains in Achondroplasia
BioMarin's vosoritide demonstrates sustained height gains in achondroplasia over eight years, with stable proportions and preserved bone mineral density.
Cartesian Therapeutics Reports Q1 2026 Results, Narrows Runway to Mid-2027
Cartesian Therapeutics reports Q1 2026 results with $120.4M cash and mid-2027 runway amid three simultaneous CAR-T trials.
Kymera Advances STAT6 Degrader KT-621 in Phase 2b Atopic Dermatitis, Asthma Trials
Kymera advances STAT6 Degrader KT-621 in Phase 2b trials for atopic dermatitis and asthma, testing oral transcription factor degradation...
Rezolute’s Ersodetug Missed Primary Endpoint but Shows CGM Benefits in Hyperinsulinism Trial
Rezolute's ersodetug missed its primary endpoint but demonstrated consistent CGM-based improvements in time in hypoglycemia across multiple analyses.
FDA Approves Vepdegestrant for ESR1-Mutant Advanced Breast Cancer
Vepdegestrant approved by FDA for ESR1-mutant advanced breast cancer, reducing progression risk by 43% versus fulvestrant in the VERITAC-2...
FDA Approves Tradipitant, First New Motion Sickness Drug in 40 Years
FDA approves tradipitant, the first new motion sickness drug in 40 years, with clinical trials conducted under actual sea-travel...