Browsing Tag
European Medicines Agency
66 posts
Eli Lilly blocked in European heart failure label push: Is the GLP‑1 race now tilting to Novo Nordisk?
Find out why Eli Lilly’s bid to expand Mounjaro’s EU label for heart failure was declined and what it means for the company’s growth strategy and competitive standing.
Johnson & Johnson’s AKEEGA clears major EU hurdle with CHMP nod for mHSPC BRCA mutation indication
Johnson & Johnson’s EU backing for AKEEGA’s expanded prostate cancer label could reshape its oncology strategy and precision medicine footprint in 2026.
EMA moves Protalix (PLX) closer to extended dosing approval for Elfabrio in Fabry disease
Protalix BioTherapeutics secures EMA panel backing for monthly Elfabrio dosing in Fabry disease, unlocking a $25M milestone. See what it means for PLX.
Incyte breaks new ground in EU cancer care with first PD‑1 drug for tough gastrointestinal tumors
Discover how Incyte’s EU backing for its MacroGenics‑partnered cancer drug Zynyz could shift immunotherapy competition in gastrointestinal cancers.
Bracco Imaging gains regulatory momentum as CHMP supports gadopiclenol for patients under two
Find out how Bracco Imaging S.p.A.’s Vueway gadopiclenol won CHMP backing for infants under two and what it means for pediatric MRI safety in Europe.
The inside story behind Samsung Bioepis’ European biosimilar takeover
Samsung Bioepis reclaims control of BYOOVIZ in Europe from Biogen, launching its own brand with a PFS version due in 2026. Read what this means for biosimilars.
Moleculin hits key inflection point as pivotal MIRACLE Phase 3 AML trial completes treatment for first 45 patients
Find out how Moleculin Biotech’s pivotal MIRACLE Phase 3 milestone for Annamycin could reshape treatment for relapsed AML as Q1 2026 data approaches.
Zoetis (NYSE: ZTS) gains EMA panel endorsement for Lenivia — Could this reshape the €10bn companion-animal market?
Zoetis (NYSE: ZTS) earns EMA panel endorsement for Lenivia, a long-acting antibody injection for canine osteoarthritis pain. Find out what this means for investors and the veterinary industry.
From Phase 3 data to Wall Street panic: Why MoonLake Immunotherapeutics lost 89% overnight
MoonLake’s VELA Phase 3 update rattled investors as MLTX crashed about 89%. Find out what the data really says and how week-52 could change the outlook.
Clinuvel Pharmaceuticals (ASX: CUV) share price gains after EMA approves year-round SCENESSE dosing
Clinuvel Pharmaceuticals (ASX: CUV) gains EMA approval for year-round SCENESSE dosing, boosting patient access, revenues, and investor sentiment.