Committeefor MedicinalProductsfor HumanUse (CHMP) has adopted a positive opinion recommending marketing authorization for an updated formulation of the COVID-19 mRNA vaccine Spikevax, ...
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 ...
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 ...
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 (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 ...
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 ...
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