FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

LENZ Therapeutics Get OK for Presbyopia Eye Drops

FDA approves LENZ Therapeutics Vizz (aceclidine ophthalmic solution) 1.44% for treating presbyopia, a common age-related condition that causes blurry ...

latest-news-card-1
Medical Devices

Illumina to Pay $9.8 Million in Cybersecurity Case

Illumina agrees to pay $9.8 million to settle allegations that it violated the False Claims Act by selling genomic sequencing systems with known cyber...

latest-news-card-1
Medical Devices

Draeger Recalls SafeStar 90 Plus Ventilator Filters

Draeger recalls (Class 1) its SafeStar 90 Plus bidirectional breathing system filter after receiving reports of slow increase of CO2-curve when a gas ...

latest-news-card-1
Medical Devices

Hamilton Recalls Ventilatory Breathing Circuit Sets

Hamilton Medical recalls (Class 1) its coaxial (1.8 m) breathing circuit set with flow sensor and expiratory valve that are used with HAMILTON-C1, HAM...

latest-news-card-1
Human Drugs

Lilly Reports Favorable Data in Mounjaro CV Trial

Eli Lilly reports favorable data from the SURPASS-CVOT trial that showed its diabetes drug Mounjaro (tirzepatide) matched the cardiovascular benefits ...

Medical Devices

FDA Approves SetPoint Medical Arthritis Device

FDA approves SetPoint Medicals SetPoint System, a novel neurostimulation device to treat some rheumatoid arthritis patients.

latest-news-card-1
Biologics

Makary Blames NIH for Covid Virus

FDA commissioner Martin Makary pushes the idea that the National Institutes of Health funded the Wuhan, China, lab from which the Covid-19 virus escap...

latest-news-card-1
Human Drugs

15 Observations in Jubilant HollisterStier FDA-483

FDA has released the form FDA-483 issued with 15 observations from an inspection at the Jubilant HollisterStier drug manufacturing facility in Kirland...

latest-news-card-1
Medical Devices

Cardiosense Wearable Cleared as Heart Function Monitor

FDA clears a Cardiosense 510(k) for its CardioTag device, a wearable device capable of simultaneously capturing electrocardiogram, photoplethysmogram,...

Human Drugs

FDA Makes ISTAND Pilot Permanent

FDA says the Innovative Science and Technology Approaches for New Drugs pilot is transitioning into a permanent drug development tool qualification pr...