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Regeneron, SNY's Dupixent Get CHMP Recommendation for Label Expansion
Regeneron Pharmaceuticals, Inc. REGN announced that the blockbuster asthma drug Dupixent (dupilumab) has been recommended by ...
MRK Gets Positive CHMP Nod for Keytruda in Two Gynecologic Cancers
The Committee for Medicinal Products for Human Use recommends marketing approval for Merck's Keytruda for treating two types ...
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 ...
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 ...
Pharmabiz17h
Samsung Bioepis, Biogen receive positive CHMP opinion for aflibercept biosimilar, Opuviz
Samsung Bioepis, Biogen receive positive CHMP opinion for aflibercept biosimilar, Opuviz: Incheon, Korea Monday, September 23, 2024, 12:00 Hrs [IST] Samsung Bioepis Co., Ltd., a b ...
Daily1d
Dupixent recommended for EU approval by CHMP to treat eosinophilic esophagitis in children as young as 1 year old: Sanofi
Paris: Sanofi has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has ...
AbbVie: CHMP Adopts Positive Opinion For Mirvetuximab Soravtansine - Quick Facts
AbbVie (ABBV) announced the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion ...
Pharmabiz19h
EMA’s human medicines committee recommends marketing approval for Pfizer & BioNTech’s Omicron KP.2-adapted Covid-19 vaccine
EMA’s human medicines committee recommends marketing approval for Pfizer & BioNTech’s Omicron KP.2-adapted Covid-19 vaccine: New York Monday, September 23, 2024, 10:00 Hrs [IS ...
Yahoo Finance18h
European Commission Approves LEO Pharma’s Anzupgo® (delgocitinib) Cream for Adults with Moderate to Severe Chronic Hand Eczema (CHE)
The approval follows the recent positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal ...
Medscape3d
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.
Medindia2d
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 ...