FDA approves Armis Biopharmas VeriFixx Small Bone Implant for the fixation of osteotomies and reconstruction of the lesser toes following correction p...
FDA says Regenerative Cell Institute in Las Vegas is illegally providing cellular products to treat many diseases and conditions.
FDA clears an Andersen Sterilizer 510(k) for its EOGas 4 Ethylene Oxide Gas Sterilizer and associated accessories for sterilizing duodenoscopes and co...
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...