FDA Webview
X
about-us-banner

FDA Related News

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

Cassava Stops Controversial Alzheimers Drug Developoment

Cassava Sciences discontinues the development of its Alzheimers disease drug simufilam after announcing disappointing topline data from the Phase 3 Re...

latest-news-card-1
Human Drugs

Winrevair Study Stopped on Positive Data: Merck

Merck stops early its Phase 3 ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension due to positive stud...

latest-news-card-1
Biologics

Neurogene Gene Therapy Patient Dies After Dosing

Neurogene says a patient dosed in an ongoing Phase 1/2 gene therapy clinical trial for Rett syndrome has died.

latest-news-card-1
Human Drugs

Endo Recalls Clonazepam Due to Mislabeling

Endo recalls (Class 1) clonazepam orally disintegrating tablets due to a potential mislabeling of the product strength.

latest-news-card-1
Human Drugs

FDA Research Links Montelukast to Mental Issues

FDA researchers find potential links between the widely prescribed asthma drug montelukast (Organons Singulair) and serious mental health issues, Reut...

latest-news-card-1
Medical Devices

Counterfeit Batteries Leads to Infusion Pump Recall

ICU Medical recalls its Plum Infusion Systems after receiving reports of allegedly counterfeit batteries being used with the devices.

latest-news-card-1
Biologics

Jazz Biliary Tract Cancer BLA Approved

FDA grants Jazz Pharmaceuticals accelerated approval for a BLA for Ziihera (zanidatamab-hrii) for treating unresectable or metastatic HER2-positive bi...

latest-news-card-1
Medical Devices

2 Orthopedic Non-Spinal Bone Guidances Posted

FDA posts two medical device guidances on orthopedic non-spinal bone plates and non-spinal metallic bone screws and washers.

Medical Devices

Philips Radiology Remote Scanning Features Cleared

FDA clears a Royal Philips 510(k) for remote scanning and remote protocol adjustment features on Philips Radiology Operations Command Center.