Browsing Tag
European Medicines Agency
76 posts
Neuren Pharmaceuticals (ASX: NEU) jumped 45% in two sessions, but how much DAYBUE upside remains?
DAYBUE’s EU breakthrough sent NEU up 45% in two sessions. The harder test is whether royalties and NNZ-2591 justify A$2.25 billion.
Could Datroway become AstraZeneca and Daiichi Sankyo’s next major oncology franchise after Enhertu?
atroway has received a positive European regulatory recommendation for first-line treatment of metastatic triple-negative breast cancer in patients unable to receive immunotherapy. The decision moves AstraZeneca PLC and Daiichi Sankyo Company, Limited closer to opening a commercially important market while increasing the strategic value of their antibody drug conjugate partnership.
Could elsunersen become the asset that steadies Praxis Precision Medicines’ CNS pipeline?
Find out how Praxis’ FDA Breakthrough Therapy Designation for elsunersen could affect PRAX stock, rare epilepsy strategy and precision neuroscience today!
Is the gMG treatment race entering a lower-burden dosing phase?
Find out how Regeneron’s cemdisiran review could reshape generalized myasthenia gravis treatment, REGN stock sentiment and siRNA competition today!
Wockhardt wins FDA approval for Zaynich as #WOCKPHARMA nears 52-week high
Wockhardt Limited’s Zaynich FDA approval could reshape its antibiotic pipeline story. Find out what it means for investors and Indian pharma.
Corcept Therapeutics (NASDAQ: CORT) climbs 7% as Lifyorli launch and analyst upgrades drive cortisol re-rating
Corcept turned a stress hormone into an ovarian cancer drug. Lifyorli is launching fast and analysts are chasing, but a premium multiple prices in a lot.
What clinicians and regulators will watch next after Itvisma’s positive CHMP opinion
Novartis Pharma AG’s Itvisma gains CHMP backing. Discover what clinicians, regulators, and investors will watch next in SMA gene therapy.
How direct-to-patient delivery could become the next competitive edge in Europe’s GLP-1 race
Read how Novo Nordisk’s Wegovy delivery update could reshape Europe’s GLP-1 competition, pharmacy economics, and patient access strategy.
What the CHMP’s positive view on lomitapide reveals about the evolving HoFH treatment landscape in children
See how Chiesi Group’s paediatric lomitapide expansion could reshape HoFH treatment access, payer dynamics, and rare disease growth across Europe.
Incyte (NASDAQ: INCY) moves closer to an hidradenitis suppurativa launch as 54-week povorcitinib data hold up
Incyte Corporation’s new 54-week povorcitinib data could reshape hidradenitis suppurativa treatment. Read what it means for INCY now.