News from the FDA/CDC
News
FDA authorizes first molecular at-home, OTC COVID-19 test
The Cue OTC Test is the first molecular diagnostic test available to consumers without a prescription.
News from the FDA/CDC
J&J COVID-19 vaccine wins unanimous backing of FDA panel
The Johnson & Johnson vaccine is expected to offer more convenient dosing and be easier to distribute than the two rival products already...
News from the FDA/CDC
Variants spur new FDA guidance on COVID vaccines, tests, drugs
The FDA has already been communicating with individual manufacturers as they assess the variants’ effect on their products.
News from the FDA/CDC
CDC chief lays out attack plan for COVID variants
Public health leaders are ramping up genome sequencing of the SARS-CoV-2 virus and ensuring that sampling is geographically representative.
News
Some COVID-19 vaccine reactions could be pseudoallergic, experts say
News from the FDA/CDC
Cemiplimab approved for locally advanced, metastatic basal cell carcinoma
The approval is based on phase 2 trial results.
News from the FDA/CDC
FDA alert confirms heart and cancer risks with tofacitinib (Xeljanz)
Completed safety clinical trial shows occurrence of heart-related events and cancer in RA patients taking the Janus kinase inhibitor is higher...
News from the FDA/CDC
CDC panel: No COVID-19 vaccine safety surprises
News
Anaphylaxis cases after COVID-19 vaccine rising but still rare: CDC
News from the FDA/CDC
CDC issues COVID-19 vaccine guidance for underlying conditions
The CDC guidance had specific information for people with ...
News from the FDA/CDC
Moderna’s COVID-19 vaccine deemed ‘highly effective,’ but further studies needed
The primary safety endpoint was to characterize the safety of the vaccine following one or two doses.