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Results For "authorization"

302 News Found

Covovax for teens get DCGI nod
Drug Approval | March 23, 2022

Covovax for teens get DCGI nod

It is the fourth vaccine to get the nod for 12 years and older after Biological E’s Corbevax, Bharat Biotech’s Covaxin and Zydus Lifesciences Zy-CoV-D


Pfizer voluntary recall of drugs in the US
News | March 23, 2022

Pfizer voluntary recall of drugs in the US

Voluntary nationwide recall of lots of Accuretic (quinapril HCl/hydrochlorothiazide), quinapril and hydrochlorothiazide tablets, and quinapril HCl/hydrochlorothiazide tablets due to n-nitroso- quinapril content


Health Canada authorizes Moderna's COVID-19 vaccine in children (6-11 Years)
News | March 18, 2022

Health Canada authorizes Moderna's COVID-19 vaccine in children (6-11 Years)

The announcement follows recent authorization of the Company's mRNA COVID-19 vaccine in Australia and the European Union for children aged 6-11 years


USFDA EUA for point-of-care Covid-19 rapid PCR test
Medical Device | March 17, 2022

USFDA EUA for point-of-care Covid-19 rapid PCR test

DASH enables non-laboratory personnel to insert a nasal swab specimen directly into our test cartridge and then load the cartridge into the DASH instrument, providing an accurate result in about 15 minutes


Ascletis increases ritonavir production capacity to 530 million tablets a year
Biotech | March 14, 2022

Ascletis increases ritonavir production capacity to 530 million tablets a year

Ritonavir oral tablet is a pharmacokinetic booster of multiple oral antiviral drugs targeting viral proteases and a component of the approved oral antiviral drug Paxlovid (Nirmatrelvir 300 mg tablet + ritonavir 100 mg tablet co-administration package)


BioPharma’s Herceptin biosimilar Phase 3 results positive
Biotech | March 12, 2022

BioPharma’s Herceptin biosimilar Phase 3 results positive

The study met its primary endpoint and showed equivalent efficacy and a comparable safety profile


Non-hazardous viral inactivation medium for Covid-19 available in Europe
Medical Device | March 10, 2022

Non-hazardous viral inactivation medium for Covid-19 available in Europe

Breakthrough formulation helps reduce the risk of exposure using a non-hazardous formulation and leakproof format during transport and processing


Jardiance is first and only treatment approved in Europe for chronic heart failure
Drug Approval | March 07, 2022

Jardiance is first and only treatment approved in Europe for chronic heart failure

The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with preserved ejection fraction (HFpEF), an underserved patient population that previously had no approved therapies in Europe


USFDA refuses to grant EUA to Covaxin for padeatric use
News | March 04, 2022

USFDA refuses to grant EUA to Covaxin for padeatric use

Covaxin is not approved in the USA for any age group


Singapore first to top WHO’s classification of medical regulator
News | March 01, 2022

Singapore first to top WHO’s classification of medical regulator

Achieving ML 4 brings Singapore closer to becoming a WHO listed authority, a new scheme that will be operational later this year and will list the world’s regulators of reference