Browsing Tag
European Medicines Agency
66 posts
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.
Vertex Pharmaceuticals bags UK approval for ALYFTREK, a next-generation cystic fibrosis treatment
The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for ALYFTREK (deutivacaftor/tezacaftor/vanzacaftor), a next-generation…
Lilly’s Jaypirca moves closer to European approval for relapsed chronic lymphocytic leukemia
Eli Lilly and Company (Lilly) has moved one step closer to securing European approval for its targeted blood…
CHMP backs Lecanemab again for early Alzheimer’s as EC reviews approval
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reaffirmed its positive opinion on…
Janssen’s subcutaneous amivantamab gains CHMP backing for EGFR-mutated lung cancer
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a…