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 ...
EU drug regulator approves use of Bavarian Nordic's mpox vaccine, Imvanex for adolescents: Copengagen, Denmark Saturday, September 21, 2024, 10:00 Hrs [IST] Bavarian Nordic A/S, a ...
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 ...
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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