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1276 News Found

US FDA grants Emergency Use Authorisation for Covid-19 pooled samples
Biotech | September 14, 2021

US FDA grants Emergency Use Authorisation for Covid-19 pooled samples

Visby Medical’s instrument-free PCR test to detect the SARS-CoV-2 virus can now be used to pool up to five patient samples using a single test


European Commission grants market authorisation for BioMarin’s Voxzogo
Biotech | August 28, 2021

European Commission grants market authorisation for BioMarin’s Voxzogo

It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo


Zydus Cadila receives Emergency Use Authorisation for 3-dose ZyCoV-D vaccine
Biotech | August 20, 2021

Zydus Cadila receives Emergency Use Authorisation for 3-dose ZyCoV-D vaccine

This is the world’s first Covid=19 DNA vaccine developed in partnership with DBT-BIRAC


Caplin Point Lab's subsidiary receives nod from Brazil's ANVISA for sterile injectable manufacturing site
Drug Approval | August 17, 2021

Caplin Point Lab's subsidiary receives nod from Brazil's ANVISA for sterile injectable manufacturing site

The approval allows it to market its products in the country


Roche receives emergency use authorisation of COVID-19 drug
News | May 07, 2021

Roche receives emergency use authorisation of COVID-19 drug

This Emergency Use Authorisation will now enable Roche to import the globally manufactured product batches to India


ImmunityBio scores first Asian approval for ANKTIVA in Macau
News | March 25, 2026

ImmunityBio scores first Asian approval for ANKTIVA in Macau

The Macau authorization followed a regulatory review that considered prior decisions by both the US FDA) and the European Medicines Agency


Rhythm Pharmaceuticals’ Phase 3 EMANATE trial falls short of primary goals
Clinical Trials | March 20, 2026

Rhythm Pharmaceuticals’ Phase 3 EMANATE trial falls short of primary goals

The study included four independent genetic substudies targeting obesity caused by heterozygous variants in the POMC/PCSK1, LEPR, SRC1 (NCOA1), and SH2B1 genes