Stelis's small-scale cGMP manufacturing facility is designed to support smallscale commercial and cGMP clinical trial material generation
TAK-003 is currently undergoing regulatory review for potential licensure in both the European Union
68% of patients receiving Kymriah in the ELARA trial experienced a complete response, with an 86% overall response rate, along with a remarkable safety profile
Data from the three studies formed the basis of the company's application for approval by regulatory agencies
This Keytruda combination is the first immunotherapy option approved in the EU for high-risk early-stage TNBC
Pfizer calls upon global health leaders and organizations to join the Accord, bringing their expertise and resources to close the health equity gap
Approval follows CHMP recommendation for use in patients previously vaccinated with Vaxzevria or an EU-approved mRNA Covid-19 vaccine
The European Commission granted CMA in December 2021 for use of Nuvaxovid in individuals aged 18 and over, and Novavax filed for expanded CMA for use in adolescents aged 12 through 17 in March 2022
Bempedoic Acid administered as a 180-mg dose, is approved by the USFDA and European Union for the treatment of hypercholesterolemia
Children 5 through 11 years of age are now authorized to receive a booster dose at least five months after the second dose of the two-dose primary series
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