The FDA is implementing a body of accredited testing facilities to streamline the medical device testing process internationally. The agency has released final guidelines for the program today (9/25) outlining the steps medical device companies must take in order to...
A study participant participates in a clinical trial, contributing invaluable data to understanding the safety and efficacy profile of a drug. Yet, patients, despite risking their lives by participating in a clinical trial, don’t usually get to know the outcome of the...
Orphazyme, a biotech company based in Denmark, announced today (9/16) that the FDA has accepted its New Drug Application (NDA) for treatment of Niemann-Pick disease Type C. The genetic disease is both rare as well as fatal, with no currently approved...
Edwards Lifesciences has developed the Sapien 3 transcatheter heart valve for cardiac treatment which was approved yesterday (9/8) by the U.S. Food and Drug Administration (FDA) for pediatric and adult patients. Transcatheter heart valves is an option for the new...
BeyondSpring, a global biopharmaceutical company focusing on immune-oncology therapy treatments for cancer patients, received today (9/8) breakthrough therapy designations (BTD) from the U.S. Food and Drug Administration (FDA) as well as the China National Medical...
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