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2985 News Found

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine
Drug Approval | February 25, 2023

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.


Pfizer’s Elranatamab receives FDA and EMA filing acceptance
Drug Approval | February 25, 2023

Pfizer’s Elranatamab receives FDA and EMA filing acceptance

Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma


SERDA therapeutics submits IND for wound debridement agent
Drug Approval | February 24, 2023

SERDA therapeutics submits IND for wound debridement agent

Clinical studies are expected to start in Q2 2023.


Moderna and Merck announce investigational personalized cancer vaccine mRNA-4157/V940
Drug Approval | February 23, 2023

Moderna and Merck announce investigational personalized cancer vaccine mRNA-4157/V940

Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial


Research underscores Beyfortus’ potential to prevent RSV disease in infants
News | February 23, 2023

Research underscores Beyfortus’ potential to prevent RSV disease in infants

The new Beyfortus data are consistent with all data accumulated to date and confirm its strong profile


Thyrocare adopts SigTuple’s AI100 to make quality diagnostics accessible
Digitisation | February 22, 2023

Thyrocare adopts SigTuple’s AI100 to make quality diagnostics accessible

In a bid to better leverage its clinical expertise and drive quality reporting across its centres, Thyrocare has added SigTuple’s AI100 to automate the microscopic review in its laboratories


Merck updates on Phase 3 MOVe-AHEAD trial evaluating Lagevrio
News | February 22, 2023

Merck updates on Phase 3 MOVe-AHEAD trial evaluating Lagevrio

The safety profile of LAGEVRIO in this trial was generally consistent with that observed in previously reported clinical studies


USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
Drug Approval | February 22, 2023

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency


Redcliffe Labs launches BD MAX MDR TB test for MDR-TB in a Single test
Clinical Trials | February 21, 2023

Redcliffe Labs launches BD MAX MDR TB test for MDR-TB in a Single test

Becomes the 1st diagnostics company in India to launch BD MAX MDR TB test


Teijin and Axcelead to establish drug discovery research JV
News | February 21, 2023

Teijin and Axcelead to establish drug discovery research JV

The new company will utilize Teijin's drug discovery research technologies, facilities, equipment and personnel.