Henlius and Intas receive Positive CHMP Opinion for HETRONIFLY® (approved as HANSIZHUANG in China) in European markets as First-Line Treatment for adult pati…
HANSIZHUANG ® (serplulimab) was the first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC – ...
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 ...
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 ...
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 ...
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.
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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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 ...
Pharmaceutical Technology on MSN1d
EMA approves Bavarian Nordic’s mpox vaccine for teenagers
Bavarian Nordic’s MVA-BN vaccine is called Imvanex in Europe but is known as Jynneos in countries such as the US and ...
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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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] ...
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EU Approves Use of Bavarian Nordic's Mpox Vaccine for Adolescents
Bavarian Nordic's mpox vaccine has gained approval for use in adolescents by the EU's drug regulator. This move is seen as ...
Medscape1d
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 ...