Braeburn says its Brixadi treatment for opioid use disorder is available to be marketed 12/1/20 after FDA revoked the orphan drug designation for Indi...
FDA issues a guidance explaining the process to seek review of a Certificate to Foreign Government denial.
Ropes & Gray says the Supreme Court will consider whether the SEC has the legal authority to seek disgorgement as an enforcement tool in a case that c...
GlaxoSmithKline says it will seek approval for Nucala (mepolizumab) for treating patients living with Hypereosinophilic Syndrome based on just-announc...
Federal Register notice: FDA announces a 12/6 public workshop on incorporating clinical outcome assessments into endpoints for regulatory decision mak...
FDA releases an FDA-483 with four inspection observations on an inspection at Isorx Corp.
FDA clears a NantHealth 510(k) for its Omics Core, a whole exome tumor-normal in vitro diagnostic that measures overall tumor mutational burden in can...