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Results For "marketing-authorization"

155 News Found

Pharming gets positive review from UK MHRA for leniolisib
Biotech | April 26, 2022

Pharming gets positive review from UK MHRA for leniolisib

A Promising Innovative Medicine (PIM) designation is an early indication that leniolisib is a candidate for the MHRA's Early Access to Medicines Scheme


CHMP adopts positive opinion on Tabrecta for advanced non-small cell lung cancer
Biotech | April 23, 2022

CHMP adopts positive opinion on Tabrecta for advanced non-small cell lung cancer

With one of the most diverse lung cancer development programs, Novartis is focused on investments to advance the science, drive treatment and make an impact on patients


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