fda-and-biotech News
BeiGene's Brukinsa Sets New Bar with Landmark 6-Year Cancer Data
Drug shows 74% of untreated leukemia patients remain progression-free, bolstering its market-leading position against key rivals from AbbVie and AstraZeneca.
J&J Shares Rise on 'Unprecedented' Myeloma Drug Combo Data
Phase 3 trial shows an 83% reduction in disease progression, positioning TECVAYLI-DARZALEX duo as a new standard of care.
Teva Shares Near Highs on FDA Filing for Key Schizophrenia Drug
Submission for its long-acting injectable TEV-749, designed to avoid a critical safety issue of a rival drug, marks a pivotal moment in the company's growth strategy.
Ascendis Pharma Dips After FDA Extends Key Drug Review
The U.S. regulator pushed its decision on TransCon CNP for achondroplasia to early 2026, a move analysts see as a procedural delay rather than a major setback.
Celldex Jumps to 52-Week High on Late-Stage Trial Launch
Biotech company initiates pivotal Phase 3 study for its novel chronic hives treatment, barzolvolimab, targeting a significant unmet need.
Terns Pharma Stock Soars Over 80% on Promising Leukemia Drug Data
Phase 1 trial for TERN-701 shows a 75% response rate at higher doses, positioning it as a strong competitor to Novartis's blockbuster Scemblix.
Merck Faces New Threat to Keytruda as Biosimilar Race Heats Up
A new partnership to develop a Keytruda copycat highlights the growing long-term challenge to Merck's blockbuster cancer drug, which accounts for nearly half its revenue.
Dyne Therapeutics Surges on Promising Duchenne Muscular Dystrophy Data
Z-rostudirsen shows significant dystrophin production and functional improvement, setting up a potential challenge to existing treatments.