The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Syndax Pharmaceuticals for the treatment of relapsed/refractory acute leukemia with either MLLr or NPM1 mutations called SNDX-5613. Previously, SNDX-5613 was granted Orphan Drug...
Japan’s regulatory body, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), has granted HUYABIO International, Shenzhen Chipscreen Biosciences’ licensing partner, regulatory approval for leukemia drug therapy, Tucidinostat. Tucidinostat, also...
In our last Latin American series blog post, we introduced the diversity and complexity of the life science market in the region, with specific focus on Brazil’s regulatory body and track for medical devices. This week, continuing with our Latin American series, we...
The National Medical Products Administration (NMPA) has approved the first CAR T-cell therapy called Yescarta for China, which has been found to be successful in treating certain kinds of late-stage blood cancer. Fosun Pharma Kite Biotechnology will market Yescarta in...
Following up on their NDA resubmission, Fennec Pharmaceuticals has been granted U.S. Food and Drug Administration (FDA) approval for its unique formulation of sodium thiosulfate called PEDMARK™. PEDMARK™ is meant to prevent ototoxicity in patients between one month...
The U.S. Food and Drug Administration (FDA) has authorized the Hope Biosciences Stem Cell Research Foundation (HBSCRF) to conduct Phase II clinical trial for simultaneous allogeneic adipose-derived mesenchymal stem cells administered intravenously to treat...
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