FDA Related News

Medical Devices

FDA Clears Sonic Incytes Velacur Device

FDA clears Sonic Incytes Velacur Determined Fat Fraction measuring tool.

Federal Register

Priority Voucher Used on Incytes Opzelura

Federal Register notice: FDA announces that it approved Incytes Opzelura (ruxolitinib) using a rare pediatric disease priority review voucher.

Human Drugs

FDA Mulls More Post-Inspection Feedback: Cavazzoni

CDER director Patrizia Cavazzoni tells a drug regulatory conference that FDA is considering more opportunities for sponsors to learn about inspection ...

Follow FDA Online Misinformation Guidance: Attorneys

Two Cooley attorneys urge companies regulated by FDA to follow the guidelines in a 7/8 draft guidance on responding to misinformation carried on the I...

Medical Devices

DeepWell Digital Software Cleared for Stress Relief

FDA clears a DeepWell Digital Therapeutics 510(k) for its biofeedback software development kit for use in over-the-counter treatments to relieve stres...

Federal Register

Whole Exome Sequencing Devices are Class 2

Federal Register notice: FDA classifies whole exome sequencing devices into Class 2 (special controls).

Federal Register

Aisa Pharma Orphan Status for Cilnidipine

Aisa Pharma wins an FDA orphan drug designation for its investigational drug AISA-021 (cilnidipine) and its use in treating systemic sclerosis.

Federal Register

Cell-Free Nucleic Acid Collector is Class 2

Federal Register notice: FDA classifies blood collection devices for cell-free nucleic acids into Class 2.

Human Drugs

GSK Highlights Depemokimab Asthma Data

GSK says data from two clinical trials showed that depemokimab significantly reduces asthma exacerbations in patients with severe Type 2 inflammation.

Human Drugs

Hold Removed on Rezolute Hypoglycemia Drug

FDA removes a partial clinical hold against Rezolutes RZ358 (ersodetug), an investigational drug for treating hypoglycemia caused by congenital hyperi...