Pharmaceutical Technology11m
EMA CHMP recommends MSD’s KEYTRUDA for gynaecological cancers
The EMA CHMP has recommended approval of MSD’s KEYTRUDA for two gynaecological cancers: endometrial and cervical.
Hosted on MSN2d
NVO Gets Positive CHMP Opinion for Wegovy's Label Update in EU
Novo Nordisk A/S NVO announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) ...
Yahoo Finance4h
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 Products ...
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 – ...
Pharmabiz5h
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 ...
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 ...
Pharmabiz2h
EMA committee recommends marketing approval for AbbVie’s mirvetuximab soravtansine for the treatment of certain adult ovarian cancer
North Chicago, Illinois Monday, September 23, 2024, 13:00 Hrs [IST] ...
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 ...
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 ...
Apellis Receives Negative CHMP Opinion for Pegcetacoplan for Geographic Atrophy (GA) in the EU Following Re-Examination
This CHMP opinion was made despite broad support for pegcetacoplan from the European retina community and multiple dissenting votes by CHMP members who supported a path to approval.” “We have seen the ...
Medscape2d
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 ...
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 ...