Browsing Tag
European Medicines Agency
70 posts
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.
Johnson & Johnson (NYSE: JNJ) wins key CHMP backing for nipocalimab in gMG—could this reshape Europe’s autoimmune treatment market?
Johnson & Johnson’s nipocalimab wins CHMP backing for gMG, setting stage for potential EU approval in adults and adolescents. Learn what this means for patients.
Bio-Thera extends partnership with STADA to bring tocilizumab biosimilar across Europe
Bio-Thera and STADA extend alliance to bring tocilizumab biosimilar across Europe, expanding immunology access and reshaping the biosimilars market.
IntraBio’s AQNEURSA earns positive CHMP opinion, bringing Niemann-Pick disease type C therapy closer to EU approval
IntraBio’s AQNEURSA earns positive CHMP opinion for Niemann-Pick disease type C, moving closer to EU approval after strong Phase III data and U.S. FDA nod.
Johnson & Johnson seeks EMA approval to expand AKEEGA use for HRR-altered prostate cancer patients
Johnson & Johnson files for EMA approval to extend AKEEGA use in high-risk prostate cancer. Find out how this combo may redefine standard of care.
NB.1.8.1 variant triggers global COVID-19 surge amid endemic transition
NB.1.8.1 variant drives global COVID-19 surge; China, Australia report highest transmission. WHO classifies risk as low but urges continued vaccine surveillance.
CStone targets European expansion with EMA filing for Sugemalimab in stage III NSCLC
CStone Pharmaceuticals seeks EMA approval for sugemalimab in stage III NSCLC, aiming to expand lung cancer immunotherapy options in Europe.