Drug Approval | November 14, 2022
Stelis receives recommendation from EMA granting market authorization for Kauliv
Kauliv provides reusable and disposable pen2 device options to cater to the global market demand.
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
CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine
First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients
First and only PARP inhibitor to improve invasive disease-free survival in patients
Tabrecta is the number one prescribed targeted therapy for advanced NSCLC with alterations leading to METex14 skipping globally
Approval follows CHMP recommendation for use in patients previously vaccinated with Vaxzevria or an EU-approved mRNA Covid-19 vaccine
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