Drug Approval | September 21, 2022
Tezspire approved in the EU for the treatment of severe asthma
First and only biologic approved in the EU in patients with severe asthma with no phenotype or biomarker limitations
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
Findings to be featured in a late-breaking proffered paper session at European Society for Medical Oncology (ESMO) Congress 2022
CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine
The integrated capabilities at Unit 2 offer significant operational flexibility, greater efficiency, and varied scope within the same premise
On the precision oncology front, expanded larotrectinib data will focus on efficacy and safety findings for pediatric and adult patients with NTRK gene fusion-positive solid tumors
First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint of the OlympiA trial, in these patients
Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union
QIAstat-Dx Viral Vesicular Panel tests for six pathogens that produce similar symptoms
This next-generation bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant.
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