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October 30, 2020
The Center for Drug Evaluation and Research is studying factors that influence the development of generic versions of brand-name drugs.
The agency published clinical data on remdesivir and information about COVID-19 treatments that have received scientific advice or informal guidance from EMA’s pandemic Task Force.
FDA published guidance for submitting standardized study data in electronic format.
October 29, 2020
The complaint aims to stop the company from manufacturing and distributing animal drugs in conditions unsatisfactory to the minimum regulatory requirements to ensure safety and quality.
FDA has granted priority review for the companies’ sBLA for Enhertu, an ADC for treating gastric cancers.
Pfizer has announced that FDA has accepted for filing and granted priority review designation for a new drug application and EMA has accepted the MAA for abrocitinib.
October 28, 2020
Delivery will commence over the course of two months following the EUA and the government will have the ability to purchase up to 650,000 additional vials of the treatment through June 30, 2021 based on product availability and medical need.
October 23, 2020
Gilead’s antiviral drug Veklury is the first approved treatment in the US for COVID-19.
October 22, 2020
EC has granted orphan drug designation to Pharming Group for its treatment of activated phosphoinositide 3-kinase delta syndrome, leniolisib.
The Swiss marketing and distribution partner of Diurnal Group, EffRx Pharmaceuticals, has submitted a MAA for Alkindi to Swissmedic.