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Results For "marketing-authorization"

183 News Found

Qvella FAST System and FAST-PBC get CE marked and USFDA listed
Biotech | April 22, 2022

Qvella FAST System and FAST-PBC get CE marked and USFDA listed

With the commercialization of Qvella technology for Positive Blood Culture (PBC) processing, healthcare facilities can now get results up to 24 hours faster than current methods


Switzerland grants conditional marketing authorisation for Novavax Covid-19 vaccine
Biotech | April 13, 2022

Switzerland grants conditional marketing authorisation for Novavax Covid-19 vaccine

Nuvaxovid is the first protein-based Covid-19 vaccine authorized for use in Switzerland


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


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


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


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


VBI’s 3-antigen Hepatitis B vaccine gets CHMP nod
Biotech | February 27, 2022

VBI’s 3-antigen Hepatitis B vaccine gets CHMP nod

If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.