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Results For "EMA"

2403 News Found

NATCO launches generic Pomalidomide Capsules in Canada
News | March 01, 2023

NATCO launches generic Pomalidomide Capsules in Canada

Natco launched pomalidomide under their brand NAT-POMALIDOMIDE in strengths of 1 mg, 2 mg, 3 mg and 4 mg capsules


Venus Remedies awarded Saudi GMP approval for all its production facilities in Baddi
Drug Approval | February 28, 2023

Venus Remedies awarded Saudi GMP approval for all its production facilities in Baddi

The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region


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


India hospital network launched to initiate life-saving colon cancer trial
News | February 28, 2023

India hospital network launched to initiate life-saving colon cancer trial

Twelve hospitals across India will be part of the network which will support the trial in India


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.


MEI Pharma and Infinity Pharmaceuticals inks merger agreement to advance three promising clinical oncology candidates
Diagnostic Center | February 24, 2023

MEI Pharma and Infinity Pharmaceuticals inks merger agreement to advance three promising clinical oncology candidates

Projected ~US$100 million cash balance of combined company expected to fund operations through mid-2025 and to clinical data over the next 12 to 24 months


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


Genomics, big data among key themes driving M&A activity in medical devices, says GlobalData
News | February 22, 2023

Genomics, big data among key themes driving M&A activity in medical devices, says GlobalData

A total of 889 M&A deals were announced in the medical devices sector in 2022 worth $93 billion


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


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