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Results For "authorization"

309 News Found

Proof Diagnostics seeks EUA for CRISPR-based molecular point-of-care Covid-19 test
Biotech | April 08, 2022

Proof Diagnostics seeks EUA for CRISPR-based molecular point-of-care Covid-19 test

If authorized by the USFDA, the Proof Lab Test System may be used to deliver accurate, actionable, lab-quality results for Covid-19 in as little as 18 minutes


Covestro and PharmaJet work to take the sting out of vaccinations
Biotech | April 07, 2022

Covestro and PharmaJet work to take the sting out of vaccinations

Makrolon polycarbonate is key to needle-free injections that can stand up to sterilization


USFDA grants priority review to Roche’s Actemra/RoActemra to treat Covid-19
News | April 04, 2022

USFDA grants priority review to Roche’s Actemra/RoActemra to treat Covid-19

If approved, it will be the first USFDA-approved immunomodulator for the treatment of Covid-19 in hospitalised patients


Intas and Axantia sign an exclusive agreement for Ranibizumab biosimilar
Biotech | April 04, 2022

Intas and Axantia sign an exclusive agreement for Ranibizumab biosimilar

Intas has developed a biosimilar of Lucentis, which is currently under Phase III global trial for submission in major countries including EMA & the US


USFDA approves EUA for second booster dose of Moderna
News | March 29, 2022

USFDA approves EUA for second booster dose of Moderna

50 µg dose approved for all adults over 50 years of age and immunocompromised adults over 18 years of age


New spesolimab data show promising results in patients with generalised pustular psoriasis flares
Biotech | March 28, 2022

New spesolimab data show promising results in patients with generalised pustular psoriasis flares

Clinical improvements were consistent across patient subgroups including age, gender, ethnicity, and IL-36 gene mutation status


Novavax to participate in two booster studies using its COVID-19 vaccine
Biotech | March 26, 2022

Novavax to participate in two booster studies using its COVID-19 vaccine

U.S. NIAID-sponsored trial will evaluate heterologous booster regimens, including NVX-CoV2373, after primary series with current USFDA approved or emergency use authorized-vaccines


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