News from the FDA/CDC
News
CDC adds new medical conditions to COVID-19 high-risk list
...
Feature
FDA scrutinizes cancer therapies granted accelerated approval
News from the FDA/CDC
CDC data strengthen link between obesity and severe COVID
Progressively intensive management of COVID-19 might be needed for patients with more severe obesity.
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
Pembrolizumab SCLC indication withdrawn in U.S.
The small cell lung cancer indication had been granted an accelerated approval, but a subsequent confirmatory study showed no survival benefit.
News from the FDA/CDC
Bladder cancer indication withdrawn for durvalumab
AstraZeneca has withdrawn durvalumab’s indication for the treatment of metastatic bladder cancer after a phase 3 trial showed no survival benefit...
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
FDA approves cemiplimab-rwlc for NSCLC with PD-L1 expression
This approval “means physicians and patients have a potent new treatment option against this deadly disease.”
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 from the FDA/CDC
FDA approves first drug that protects against chemo-induced myelosuppression