The U.S. Food and Drug Administration (FDA) has granted full approval to Pfizer-BioNTech’s COVID-19 vaccine, making it the first vaccine to achieve that status. The mRNA-based vaccine has been available since late last year through an Emergency Use Authorization (EUA), and will continue to be offered under that designation for those aged 12 to 15 […]
FDA approves Pfizer’s COVID-19 vaccine, now called Comirnaty
The full approval applies to a two-dose regimen for those ages 16 and up.
Report: Pfizer’s COVID-19 vaccine may get full FDA approval Monday
Regulators are reportedly working to finish approval Friday, but timeline could slip.
What to know about the US COVID booster plan—and why WHO hates it
US officials make judgment call on boosters as WHO worries about global supply, variants.
BrainQ raises $40M to transform stroke patient rehabilitation with its home therapy device
If you injure your elbow, surgery can help. If you lose a leg, prostheses are available. But problems within the brain are more difficult to treat, and for stroke victims rehabilitation is largely left to the body’s own repair mechanisms. BrainQ aims to change that with a device that stimulates the damaged part of the […]
FDA authorizes 3rd COVID vaccine dose for immunocompromised [Updated]
CDC advisers plan to meet Friday to set official guidance.
a heart pump is a life-sustaining medical device
Thousands of Patients Were Implanted With Heart Pumps That the FDA Knew Could Be Dangerous. (ProPublica, Aug. 5, 2021) As HeartWare and Medtronic [which acquired HeartWare in 2016] failed inspection after inspection and reports of device-related deaths…
Aduhelm approval sparks HHS watchdog review of FDA’s accelerated approval pathway
The Department of Health and Human Services (HHS) Office of the Inspector General will review the FDA’s accelerated approval pathway, the office announced Wednesday. This sweeping review comes just two months after the controversial approval of Biogen’s Alzheimer’s drug Aduhelm. The review will focus on the FDA’s accelerated approval pathway — a route that allows […]
costs $56,000 per year
A few weeks ago, the FDA approved a costly Alzheimer’s drug developed by Biogen, but for what benefit?1. There is not strong evidence that Amyloid beta plaques causes Alzheimer’s disease, even if aducanumab showed a reduction in those plaques.2. Aducan…
Maker of dubious $56K Alzheimer’s drug offers cognitive test no one can pass
After facing intense criticism, Biogen goes on defense, blames “misinformation.”