Operation Warp Speeds Janet Woodcock says a lesson learned from the Covid-19 experience is the need to establish infectious disease networks that can ...
Huron Therapeutics says it has resubmitted to FDA its NDA for HTX-011, an investigational non-opioid analgesic indicated for treating postoperative pa...
FDA clears the Lantheus automated bone scan index to be used on the GE Healthcare Xeleris platform.
Attorney James Beck says a California federal court dismissed two Nexus Pharmaceutical suits against drug compounders due to implied preemption.
FDA grants an additional orphan drug designation for Agios mitapavit for treating sickle cell disease.
The Justice Department says Indivior Solutions was sentenced to pay $289 million under a plea agreement for criminal charges involving unlawful Suboxo...
The Alliance for a Stronger FDA lists six programs likely to get additional funding from the FY 21 agency budget.
Federal Register notice: FDA contemplates the grant of an exclusive patent license to Advion, Inc. (Ithaca, NY) for a government-owned patent for Dire...