FDA - Food and Drug Administration
FDA clears AI model to triage urgent CT findings, Israeli firm says
Aidoc won FDA clearance for a 'foundation model' clinical AI that triages 14 abdomen-CT indications in one workflow, aiming to surface urgent findings faster amid ED crowding and imaging backlogs.
FDA clears first US trial of Israel’s EndoArt synthetic corneal implant
Arizona couple admits in court to faking cancer-curing 'smart chip' device
Forget the injections: The FDA has approved a daily weight-loss pill for the first time
Biogen pulls application for Alzheimer's drug in Europe
The drugmaker said the move follows interactions with the European Medicines Agency that suggested data provided so far would not be enough to support an approval.
Japan's Kowa says Ivermectin showed 'antiviral effect' against Omicron
Clinical trials are ongoing, but promotion of ivermectin as a COVID-19 treatment has generated controversy.
Biogen shares slide as Medicare restricts cover of Alzheimer's treatments
The coverage decision by US Centers for Medicare and Medicaid Services (CMS), the health agency that runs Medicare, crushes any hopes of the drug Aduhelm gaining traction.
Wait 3 days, then swab throat and nose when using antigen test, Health Ministry says
The Health Ministry published new recommendations on how to use the at-home kits, amid criticism for their lack of accuracy.
Controversial Alzheimer's drug administered for first time in Israel
This marks the first time that the drug has been used outside of the United States.
Israeli firm SpliSense moves to clinical trials for cystic fibrosis treatment
"It will improve patients' lung function, reduce lung inflammation, enable them to breathe better, and go back to normal life."
US FDA clears Pfizer's COVID-19 booster shot for 12- to 15-year-olds
The FDA said it reviewed published data and real-world evidence on the safety of booster doses provided by the Israeli Ministry of Health.
US authorizes German Firm's at-home COVID-19 test
The approval comes at a time when companies such as Walmart Inc, Walgreens Boots Alliance and CVS Health Corp have limited sales of at-home COVID-19 testing kits as demand surged.
Roche's at home covid test kit gets emergency FDA approval
The test, which uses a anterior nasal swab sample, is 'able to produce accurate, reliable and quick results in as few as 20 minutes' for SARS-CoV-2 and all variants of concern.
US FDA authorizes Pfizer/BioNTech booster for 16- and 17-year-olds
All US adults are currently eligible for booster shots of the three authorized COVID-19 vaccines.
