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111 News Found

Orgenics to conduct toxicology study on its intransal COVID-19 vaccine candidate
Biotech | March 23, 2022

Orgenics to conduct toxicology study on its intransal COVID-19 vaccine candidate

Data to establish the safety profile and human dose of vaccine candidate


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


Study shows Pfizer vaccine moderately effective against Omicron for children 5-15
News | March 12, 2022

Study shows Pfizer vaccine moderately effective against Omicron for children 5-15

The study looked at 1,364 children in Arizona, Florida, Texas, and Utah who submitted weekly nasal swabs and surveys from July 2021 through February 2022, regardless of whether they had symptoms


China approves BeiGene’s tislelizumab
Drug Approval | March 12, 2022

China approves BeiGene’s tislelizumab

Tislelizumab is now approved for seven indications in China


Sense receives CE marking for Veros Covid-19 instrument-free molecular test
Medical Device | March 08, 2022

Sense receives CE marking for Veros Covid-19 instrument-free molecular test

Sense anticipates launching Veros Covid-19 in Europe this quarter, initially in Ireland, Benelux and the Nordic regions


Mylab launches CoviSwift for Covid-19 Point of Care testing
Medical Device | February 03, 2022

Mylab launches CoviSwift for Covid-19 Point of Care testing

Unlike “Fast PCR” platforms - which uses LAMP/Isothermal technology and not gold standard RT-PCR - CoviSwift has high accuracy and sensitivity and is suitable for airports and hospitals


Glenmark Specialty S.A. partners with Lotus to commercialise Ryaltris in key Asian markets
News | January 20, 2022

Glenmark Specialty S.A. partners with Lotus to commercialise Ryaltris in key Asian markets

The company will receive an upfront payment as well as regulatory and sales based milestone payments from Lotus


BiologyWorks k(now) handheld molecular device 99.1 % accurate to RT-PCR test
Medical Device | January 18, 2022

BiologyWorks k(now) handheld molecular device 99.1 % accurate to RT-PCR test

Results from the BiologyWorks k(now) molecular test were 99.1% in overall percent agreement with the results of the RT-PCR lab tests


Glenmark receives U.S. FDA approval for Ryaltris
Drug Approval | January 14, 2022

Glenmark receives U.S. FDA approval for Ryaltris

The recommended daily dose for Ryaltris is 2 sprays in each nostril twice daily


Marksons Pharma receive final US. FDA approval for Cetirizine Hydrochloride tablets
Drug Approval | January 12, 2022

Marksons Pharma receive final US. FDA approval for Cetirizine Hydrochloride tablets

The product will be marketed under store brand labels and is comparable to the brand Zyrtec