Federal Register notice: FDA seeks comments on an information collection extension for Formal Dispute Resolution: Scientific and Technical Issues Rela...
FDA advisory committee briefing information confirms 95% efficacy with Pfizer-BioNTechs Covid-19 vaccine.
FDA clears a Zebra Medical Vision 510(k) for its artificial intelligence analytics that extract bone measurements from X-ray scans for planning orthop...
FDA publishes the FDA-483 with six inspection observations issued to Juno Therapeutics.
FDA issues guidances with recommended best practices to use in developing proprietary names for human prescription and non-prescription drugs.
The ACLU says federal courts should continue to block an FDA policy requiring patients seeking mifepristone to appear in person at a health center to ...
FDA says the Oncology Center of Excellences Project Orbis received 60 applications in its first full year of existence and approved 38 new drugs and n...
FDA grants Turning Point Therapeutics a breakthrough therapy designation for repotrectinib and its use in treating certain patients with gene ROS1-pos...