Medindia12m
Henlius Receives Positive CHMP Opinion for HANSIZHUANG as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
HANSIZHUANG (serplulimab) is the world's first anti-PD-1 mAb for first-line treatment of ES-  SCLC   - HANSIZHUANG (serplulimab) is expected to become the first and only anti-PD-1 ...
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EMA approves Bavarian Nordic’s mpox vaccine for teenagers
The European Medicines Agency (EMA) has approved the use of Bavarian Nordic’s mpox vaccine in adolescents, increasing the ...
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 ...
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Pfizer/BioNTech Get CHMP Nod for Omicron KP.2 EU Vaccine
Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use ...
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 ...
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 ...
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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.
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EU drug regulator approves use of Bavarian Nordic's mpox vaccine, Imvanex for adolescents
EU drug regulator approves use of Bavarian Nordic's mpox vaccine, Imvanex for adolescents: Copengagen, Denmark Saturday, September 21, 2024, 10:00 Hrs [IST] Bavarian Nordic A/S, a ...