Drug Approval | December 20, 2022
Imfinzi plus Imjudo recommended for approval in the EU by CHMP for advanced liver and lung cancers
Positive opinions based on significant survival benefit
Positive opinions based on significant survival benefit
The approval follows the positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October 2022
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations
Kauliv provides reusable and disposable pen2 device options to cater to the global market demand.
First and only next-generation protein-based adjuvanted COVID-19 booster approved in Europe
The European Commission will review the CHMP recommendation and is expected to make a final decision soon.
CHMP positive opinion is based on evidence from the EFFISAYIL trial, the largest clinical trial in
First and only biologic approved in the EU in patients with severe asthma with no phenotype or biomarker limitations
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