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...
The National Institute for Health and Care Excellence (NICE) originally rejected global biopharmaceutical company AstraZeneca’s lung cancer therapy Tagrisso (Osimertinib), but has since decided to reverse its initial decision. NICE initially did not recommend Tagrisso...
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...
The U.S. Food and Drug Administration (FDA) has approved the usage of the Guardant360 CDx and FoundationOne Liquid CDx liquid biopsy tests for a number of solid tumors. The biopsies will be conducted via the blood, hence making them less painful, and more accessible....
Biopharmaceutical company Innovnet Biologics, Inc. announced today (9/3) that the National Medical Products Administration (NMPA) has approved SULINNO®, an adalimumab injection, for rheumatoid arthritis, ankylosing spondylitis and psoriasis treatment in China....
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