NuVasive Pulse Receives CE Mark, Begins Clinical Evaluations
With an aim to transform disruptive spine surgery, NuVasive (NASDAQ: NUVA), a leader in spine technology innovation, announced that clinical evaluations have started for its Pulse® platform which recently received CE Mark (Conformitè Europëenne) approval. The Pulse...
Yiling Pharmaceutical Gains Market Access in the Ukraine
Yiling Pharmaceutical has received medicine registration document from the Ministry of Health of Ukraine for its drug therapy Lianhua Qingwen Capsules. Lianhua Qingwen Capsules are designed to treat COVID-19, as well as other viruses like the flu or cold. The medicine...
FDA Grants Fast Track Designation to Syndax Pharmaceuticals
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...
PMDA Grants Regulatory Approval for Leukemia Drug Therapy
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 referred to...
NMPA Grants First Approval to CAR T-Cell Therapy
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...
FDA Accepts Fennec Pharmaceutical’s NDA Resubmission for PEDMARK™
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...