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Results For "regulatory-approval"

316 News Found

Morpen Laboratories to transfer its medical devices business to a wholly owned subsidiary
News | September 02, 2021

Morpen Laboratories to transfer its medical devices business to a wholly owned subsidiary

The revenues and profits derived from the new subsidiary will be consolidated in the parent company


WHO releases compendium of innovative health technologies
Policy | September 01, 2021

WHO releases compendium of innovative health technologies

The Covid-19 pandemic has exposed the divide that exists between rich and developing nations and to address these challenges the World Health Organisation (WHO), has compiled a list of innovative health technologies that aim to bridge the gap


SK Bioscience and GSK start Phase 3 trial of an adjuvanted COVID-19 vaccine candidate
Drug Approval | September 01, 2021

SK Bioscience and GSK start Phase 3 trial of an adjuvanted COVID-19 vaccine candidate

Advance to Phase 3 follows positive interim Phase 1/2 immunogenicity and safety data. The global clinical trial will evaluate vaccine candidate GBP510 against the AZ/Oxford COVID-19 vaccine


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


Pfizer receives EC approval for XEIJANZ
Biotech | August 23, 2021

Pfizer receives EC approval for XEIJANZ

XELJANZ is the first and only Janus kinase (JAK) inhibitor approved in Europe for the treatment of polyarticular JIA and juvenile PsA and has received regulatory approval in four indications in the European Union, the most of any JAK inhibitor


Aurobindo Pharma calls off its acquisition of Cronus Pharma
News | August 21, 2021

Aurobindo Pharma calls off its acquisition of Cronus Pharma

The acquisition was expected to be completed in eight weeks, and it would have provided it with a foothold in the US $ 48 billion global animal health market


AstraZeneca-Sputnik V combination demonstrates high immunogenicity profile: RDIF
Biotech | August 20, 2021

AstraZeneca-Sputnik V combination demonstrates high immunogenicity profile: RDIF

Preliminary data from the first 20 participants in Azerbaijan show antibodies to the SARS-CoV-2 virus spike protein (S-protein) elicited in 100% of cases


Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19
Biotech | August 17, 2021

Pfizer & BioNTech submits Phase 1 data to US FDA for booster dose Covid-19

The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.


Manjushree Technopack set to acquire Classy Kontainers
Packaging | August 17, 2021

Manjushree Technopack set to acquire Classy Kontainers

MTL, with over 40 years of experience in packaging, caters to the requirements of the FMCG, F&B, homecare, personal care, agrochemicals, pharmaceutical, and liquor industries


Bharat Biotech’s first nasal vaccine gets approval for Phase 2 trials
Biotech | August 14, 2021

Bharat Biotech’s first nasal vaccine gets approval for Phase 2 trials

This is the first of its kind vaccine for Covid 19 to get the go-ahead