First PARP inhibitor and new hormonal agent combination approved for these patients in Europe
The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022
Omicron BA.5 continues to be the most prevalent sublineage in the United States (nearly 30% of cases) at the time of publication of the data
The European Commission will review the CHMP recommendation and is expected to make a final decision soon.
MoCD Type A is a rapidly progressive autosomal recessive inborn error of metabolism resulting in toxic sulfite levels causing neurologic sequelae
NULIBRY is a first-in-class cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A.
First and only biologic approved in the EU in patients with severe asthma with no phenotype or biomarker limitations
Evusheld significantly reduced risk of severe COVID-19 or death in TACKLE Phase III treatment trial
CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine
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