Browsing Tag
European Medicines Agency
81 posts
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…
OneSource Specialty Pharma reports stellar Q3FY25 earnings with 85% EBITDA growth, setting stage for expansion
OneSource Specialty Pharma Limited, formerly Stelis Biopharma Limited, has delivered a strong financial performance in its first full…
Sanofi strengthens cardiovascular portfolio with Aficamten rights in Greater China
Cytokinetics, Incorporated (NASDAQ: CYTK) saw its shares climb by 4.8% after announcing a landmark agreement with Sanofi (NASDAQ:…
Three biosimilars by Celltrion near EU approval following CHMP endorsement
Celltrion, a leading South Korean biopharmaceutical company, has received positive opinions from the European Medicines Agency’s (EMA) Committee…
Breakthrough EU approval for Dupixent offers new hope for children with eosinophilic esophagitis
The European Medicines Agency (EMA) has granted approval for Dupixent, a therapy developed by Sanofi and Regeneron, to…
Ionis Pharmaceuticals moves forward with FDA review of donidalorsen for HAE
In a significant development for hereditary angioedema (HAE) patients, Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S.…