Health Archive

CSOFT’s health sciences blog aims to provide a better understanding of complex diseases, and regulatory polices from conducting experiments to introducing new type of drugs into the market.

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The European Medicines Agency (EMA) Suffers Cyber Attack

The European Medicines Agency (EMA) Suffers Cyber Attack

BioNTech released a statement on December 9, 2020 that Pfizer and their COVID-19 vaccine documents was “unlawfully accessed” in a breach on the European Medical Agency's (EMA) system. The severity of the attack was not divulged, however the EMA disclosed that they...

FDA Breakthrough Designation Given to ReGelTec

FDA Breakthrough Designation Given to ReGelTec

ReGelTec, a medical device company out of Baltimore’s leading medical device HYDRAFIL, has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA). The Breakthrough Device Program was created with intentions to expedite the...

B-Cell Lymphoma Drug Receives FDA Priority Review

B-Cell Lymphoma Drug Receives FDA Priority Review

ADC Therapeutic’s Biologics License was approved by the U.S. Food and Drug Administration (FDA) for their relapsed/refractory diffuse large B-cell Lymphoma drug candidate. The antibody conjugate drug, that catalyzes cancer cell death is being investigated in a...