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Results For "regulatory"

1533 News Found

Sonowal inaugurates SCO’s first international conference on traditional medicine
News | March 04, 2023

Sonowal inaugurates SCO’s first international conference on traditional medicine

The WHO - Global Center for Traditional Medicine will help member countries in taking enabling steps in their countries for strengthen education and practices of traditional mdicine


AstraZeneca expands its portfolio by bringing rare disease therapy for patients in India
News | March 01, 2023

AstraZeneca expands its portfolio by bringing rare disease therapy for patients in India

Receives regulatory approval for its molecule ‘Selumetinib’ in India


Sanofi reaffirms commitment to rare diseases in India
News | February 28, 2023

Sanofi reaffirms commitment to rare diseases in India

Receives Subject Expert Committee recommendation to bring new therapies of Pompe, ASMD to India


AlloVir appoints Derek Adams to Board of Directors
People | February 27, 2023

AlloVir appoints Derek Adams to Board of Directors

Dr. Adams brings more than two decades of experience leading the manufacturing of biologic and gene therapies at all stages of development.


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


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


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


Dalton ramp ups sterile manufacturing capacity
News | February 20, 2023

Dalton ramp ups sterile manufacturing capacity

The new sterile filling line meets cGMP aseptic filling regulatory requirements


Merck and AstraZeneca present final results from Phase 3 PROpel Trial
Drug Approval | February 18, 2023

Merck and AstraZeneca present final results from Phase 3 PROpel Trial

Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival