Browsing Tag
European Medicines Agency
70 posts
Savara Inc. (NASDAQ: SVRA) moves closer to first approval as FDA files MOLBREEVI BLA with priority review
Savara Inc. has secured FDA priority review for MOLBREEVI in autoimmune PAP. Find out what this means for approval odds, investors, and rare lung care.
EC backs higher-dose Wegovy as obesity competition intensifies
Novo Nordisk A/S wins EU approval for 7.2 mg Wegovy. Discover how this shifts obesity competition, reimbursement, and long-term strategy.
AKEEGA moves upstream as CHMP backs PARP inhibition in metastatic hormone-sensitive prostate cancer
Find out how CHMP support for AKEEGA could shift PARP inhibitors into earlier prostate cancer treatment and reshape precision oncology strategy.
Sanofi’s second chance: Why Europe is warming up to Rezurock after initial CHMP rejection
Sanofi’s Rezurock secures EU conditional approval recommendation for chronic GVHD. Find out what changed and how this could reshape rare disease care.
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.