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Results For "EMA"

2385 News Found

Amaris Clinicals clears U.S. FDA audit
News | September 24, 2021

Amaris Clinicals clears U.S. FDA audit

The company is the Clinical Research Organisation of Caplin Point Laboratories


Aurobindo subsidiary submits MAA for oncology biosimilar
Biotech | September 23, 2021

Aurobindo subsidiary submits MAA for oncology biosimilar

CuraTeQ Biologics is on track for filing a second oncology biosimilar


Roche launches three respiratory test panels on Cobas 6800/8800 Systems in CE markets
Medical Device | September 23, 2021

Roche launches three respiratory test panels on Cobas 6800/8800 Systems in CE markets

Three new molecular diagnostic test panels for influenza and other common respiratory illnesses can be run together or alone using one patient sample


Lonza to expand its drug manufacturing network in Switzerland
Biotech | September 23, 2021

Lonza to expand its drug manufacturing network in Switzerland

Lonza, a global manufacturing partner to the pharma, biotech and nutrition industries, has announced it will invest in additional drug product manufacturing capabilities in Switzerland


UFlex joins Alliance in its mission to end plastic waste
Sustainability | September 23, 2021

UFlex joins Alliance in its mission to end plastic waste

UFlex has committed close to US $ 10 million towards various initiatives at its overseas and Indian plants to repurpose plastic waste


U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar
Drug Approval | September 21, 2021

U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar

It becomes the first ophthalmology biosimilar to gain FDA approval in the United States


HUTCHMED initiates a Japan bridging study to Support Surufatinib
Biotech | September 21, 2021

HUTCHMED initiates a Japan bridging study to Support Surufatinib

Surufatinib is the third potential new medicine discovered by the company to enter into clinical development in Japan


Pfizer and BioNTech’s Covid-19 vaccine safe for children aged 5 to 11: study
Biotech | September 21, 2021

Pfizer and BioNTech’s Covid-19 vaccine safe for children aged 5 to 11: study

In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralising antibody responses. Results in children under 5 years of age are expected as soon as later this year


AAV Production system enables scalable gene therapy workflows
Medical Device | September 21, 2021

AAV Production system enables scalable gene therapy workflows

New Gibco AAV-MAX Helper Free AAV Production System helps reduce production costs and streamline the transition from research to clinical environments


RxDx Healthcare receives NABL accreditation
Diagnostic Center | September 20, 2021

RxDx Healthcare receives NABL accreditation

RxDx is a chain of primary care driven multispecialty healthcare clinics with two main branches situated in Whitefield and Malleswaram in Bengaluru