NVO Gets Positive CHMP Opinion for Wegovy's Label Update in EU
Novo Nordisk receives a positive opinion from the CHMP for a label update of Wegovy to reflect reduced heart failure symptoms ...
Apellis Says CHMP Confirms Negative Opinion For Pegcetacoplan In Geographic Atrophy, Stock Down
Apellis Pharmaceuticals, Inc. (APLS) announced on Friday that the Committee for Medicinal Products for Human Use or CHMP of the ...
manilatimes5h
Henlius Receives Positive CHMP Opinion for HANSIZHUANG as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval ...
AbbVie Gets CHMP Backing for Elahere in Ovarian Cancer
Elahere, which won initial U.S. Food and Drug Administration approval in 2022 for platinum-resistant ovarian cancer, was the key asset in AbbVie's $10.1 billion acquisition of biotech ImmunoGen that ...
European Drug Agency Supports Novo Nordisk's Blockbuster Weight-Loss Drug Wegovy For Obesity-Related Heart Failure
Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of Novo Nordisk A/S’ (NYSE ...
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron KP.2-adapted COVID-19 Vaccine in the European Union
Upon authorization by the European Commission, the Omicron KP.2-adapted COVID-19 vaccine will be available for individuals 6 months of age and ...
Medscape1d
EMA Broadens Imvanex Vaccine Use to Teens as Mpox Cases Rise
With more than 200 mpox-related deaths reported globally, the EMA has approved Imvanex for adolescents aged 12-17 years.
Medscape18h
Hympavzi Approved in Europe for Severe Hemophilia A and B
The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) recommended the granting of ...
Apellis Pharmaceuticals, Inc.: Apellis Receives Negative CHMP Opinion for Pegcetacoplan for Geographic Atrophy (GA) in the EU Following Re-Examination
Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
Pharmabiz2h
EMA committee recommends Novo Nordisk’s Wegovy label update to reflect reduced heart failure symptoms and improved physical function
Bagsværd, Denmark Saturday, September 21, 2024, 15:00 Hrs [IST] ...
Pharmabiz1d
EMA’s human medicines committee elects Bruno Sepodes as new chair
EMA’s human medicines committee elects Bruno Sepodes as new chair: Amsterdam, The Netherlands Friday, September 20, 2024, ...
Sanofi: Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old
Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old Recommendation based on a phase 3 study showing a significantly greater proportion ...