FDA/CDC
FDA/CDC
CDC: Vaccinated? You don’t need a mask indoors
FDA/CDC
CDC recommends use of Pfizer’s COVID vaccine in 12- to 15-year-olds
ACIP voted 14-0 in favor of the safety and effectiveness of the vaccine in younger teens.
FDA/CDC
FDA clears cap device for ‘smart’ insulin pens for diabetes
The Bigfoot Unity System comprises a cap that attaches to insulin pens to provide CGM readings and dose recommendations for people with type 1 or...
FDA/CDC
FDA blazes path for ‘real-world’ evidence as proof of efficacy
FDA leaders must finalize guidance this year on submitting real-world observational evidence for regulatory decisions on drug and device efficacy...
News
FDA authorizes Pfizer COVID vaccine for teens 12-15
News
FDA panel narrowly backs avacopan approval
The FDA is mulling whether to approve avacopan for ANCA-associated vasculitis based largely on a single trial about which the agency staff has...
FDA/CDC
FDA okays upfront pembro for advanced HER2+ gastric cancer
The accelerated approval is for first-line use in combination with other agents for locally advanced unresectable or metastatic HER2-positive...
FDA/CDC
FDA set to okay Pfizer vaccine in younger teens
FDA/CDC
FDA approves dapagliflozin (Farxiga) for chronic kidney disease
Based on results of the DAPA-CKD trial, the FDA has granted approval for the diabetes drug in patients with CKD at risk for disease progression....
FDA/CDC
FDA OKs higher-dose naloxone nasal spray for opioid overdose
Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan.