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 – ...
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Bavarian Nordic Receives EMA Approval of Mpox Vaccine for Adolescents
COPENHAGEN, Denmark I 19, 2024 I Bavarian Nordic A/S (OMX: BAVA) announced today that the European Commission has adopted the Committee for ...
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 ...
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.
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 ...
Medindia9h
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 ...
AbbVie Receives Positive CHMP Opinion for Mirvetuximab Soravtansine (ELAHERE®) for the Treatment of Certain Adult Ovarian Cancer
AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing ...
Medscape22h
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: CHMP Once Again Recommends Against Syfovre
The CHMP's final opinion follows two earlier negative votes this year on the drug, which is marketed as Syfovre in the U.S. and generated $154.6 million in U.S. net product revenue for Apellis in the ...