“There’s a difference in knowing something and realizing something. We’ve known for quite a while now that we’re too dependent on other countries for our medical supplies. But during this pandemic, I think we’ve realized it,” U.S. Rep. Buddy Carter (R-Ga.) said at a recent congressional hearing on the progress being made in developing COVID-19 vaccines.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Helix, Nanotronics Health.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Appili, Aquestive, Chi-Med, Diurnal, Gilead, Mallinckrodt, Ocugen, Pluristem, Reata, Seelos, Trevena, Vaxart.
More than two weeks ahead of its expected PDUFA date, PTC Therapeutics Inc.’s spinal muscular atrophy (SM) drug, risdiplam, gained FDA approval, making it the first at-home, oral treatment intended for use in adults and children 2 months and older.
HONG KONG – A Chinese med-tech company plans to take to market what it claims is the first electrocardiography (ECG) diagnostic machine powered by AI, but as it moves to markets beyond China, it could face significant competition.