Browsing Tag
European Medicines Agency
70 posts
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.
Why the EMA review of PolTREG-T1D could influence autoimmune cell therapy development
PolTREG-T1D moves toward European Medicines Agency review. Discover how this TREG cell therapy could reshape treatment for autoimmune diseases.
United Therapeutics (NASDAQ: UTHR) pushes inhaled therapy strategy as Phase 3 Tyvaso data shows lung function preservation in IPF
United Therapeutics reports strong Phase 3 TETON-2 results for Tyvaso in idiopathic pulmonary fibrosis. Discover why this inhaled therapy could reshape treatment.
How FIREFLY1 data positioned Ojemda for conditional EU approval in pediatric glioma
How FIREFLY1 data positioned Ipsen’s Ojemda for conditional EU approval in pediatric glioma and what it means for investors and competitors.
Will mavorixafor’s EU path mirror its U.S. regulatory breakthrough in WHIM syndrome?
X4 Pharmaceuticals (NASDAQ: XFOR) wins EMA backing for mavorixafor. Explore what EU approval could mean for revenue, risk, and rare disease strategy.
Lilly’s Olumiant moves closer to European approval for teen alopecia patients as CHMP issues positive opinion
Eli Lilly's Olumiant wins CHMP backing for adolescent alopecia areata with 42% response rates — EU approval imminent, U.S. decision due late 2026. Read the full analysis.
KEYNOTE-B96 final analysis: Merck’s Keytruda cuts death risk by 18% in recurrent ovarian cancer across all-comer population
Merck's Keytruda cuts death risk 18% in platinum-resistant ovarian cancer regardless of PD-L1 status. FDA approved, EU opinion positive. Read the full analysis.