FDA says its Electronic Submission Gateway Next Generation is live and ready to receive submissions.
Vanda Pharmaceuticals criticizes FDA for wrongly claiming that recent staff cuts and a new commissioner causes it to delay a company request for a hea...
Akeso says its ivonescimab met the primary endpoint in a pivotal Phase 3 trial for the first-line treatment of advanced squamous non-small cell lung c...
FDA warns San Jose, CA-based Noah Medical about Quality System violations in its manufacturing of the Galaxy System bronchoscopes and accessories.
AstraZeneca and Daiichi Sankyo report interim data from a Phase 3 trial that showed Enhertu (trastuzumab deruxtecan), in combination with Perjeta pert...
The Democratic Lieutenant Governors Association writes president Donald Trump urging him to support and safeguard the integrity of key federal science...
FDA warns ICU Medical that its Minneapolis, MN-based Smiths Medical ASD unit is illegally marketing adulterated and misbranded infusion pumps.
Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second year of its voluntary Quality Management Maturity Pr...
