FDA says Anytime Covid Test is marketing and distributing unapproved, adulterated, and misbranded Covid-19 tests for home use.
Penrose TherapeuTx appoints former FDAer Vicki Seyfert-Margolis to its scientific advisory board.
Novo Nordisk recalls 1,468 product samples due to improper storage.
FDA releases for public comment proposed revisions to an International Council for Harmonization guideline on elemental impurities.
FDA grants breakthrough device designation to Avenda Healths prostate cancer artificial intelligence-enabled focal therapy system.
AstraZeneca submits a BLA for tezepelumab, a potential first-in-class medicine for treating severe asthma.
FDA publishes an International Council for Harmonization final guidance on technical and regulatory considerations for postapproval management of drug...
Federal Register notice: FDA seeks comments on an information collection revision entitled Registration of Producers of Drugs and Listing of Drugs in ...