Orphazyme Receives Priority Review by FDA for Treatment of Niemann-Pick Disease Type C
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...
NICE Reverses Disapproval of AstraZeneca’s Lung Cancer Therapy Tagrisso
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...
FDA Approves Edwards’ Sapien 3 for Cardiac Treatment
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...
FDA and NMPA Grant BeyondSpring Breakthrough Therapy Designations for Chemotherapy-Induced Neutropenia Indication
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...
FDA Approves Liquid Biopsy Tests
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....
NMPA Approves Adalimumab Injection SULINNO® for Arthritis Treatment
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....