FDA approves a Lantheus Holdings/Progenics Pharmaceuticals supplemental NDA for Definity Room Temperature (perflutren lipid microsphere) injectable su...
Pfizer and BioNTech plan to submit within days an Emergency Use Authorization request for their Covid-19 vaccine candidate BNT162b2 after a final anal...
Federal Register notice: FDA seeks comments on an information collection extension entitled Expedited Programs for Serious Conditions Drugs and Biolo...
Federal Register notice: FDA sends to OMB an information collection revision related to the registration of human drug compounding outsourcing facilit...
The HHS Inspector General says drug and device companies and healthcare professionals should weigh the risks when considering whether to participate i...
Federal Register notice: FDA corrects a notice that appeared in the 1/8 Federal Register announcing the approval withdrawals for 19 NDAs from multiple...
Sens. Grassley and Warren ask FDA to promptly issue its proposed rule on OTC hearing aids.
A petition submitted for an unnamed client asks FDA not to approve roxadustat for treating anemia in patients with chronic kidney disease unless the a...