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FDA Clears Sonic Incytes Velacur Device

[ Price : $8.95]

FDA clears Sonic Incytes Velacur Determined Fat Fraction measuring tool.

Priority Voucher Used on Incytes Opzelura

[ Price : $8.95]

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

FDA Mulls More Post-Inspection Feedback: Cavazzoni

[ Price : $8.95]

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

Class 2 for Endoscopic Pancreatic Debridement Devices

[ Price : $8.95]

Federal Register notice: FDA classifies endoscopic pancreatic debridement devices into Class 2 (special controls).

CBER Updates Refusal-to-File Procedure

[ Price : $8.95]

CBER posts an updated standard operating policy and procedure (SOPP) manual entitled SOPP 8404: Refusal to File (RTF) Procedures. ...

Cell-Free Nucleic Acid Collector is Class 2

[ Price : $8.95]

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

GSK Highlights Depemokimab Asthma Data

[ Price : $8.95]

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

Hold Removed on Rezolute Hypoglycemia Drug

[ Price : $8.95]

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

Femasys Fallopian Tube Diagnostic Cleared

[ Price : $8.95]

FDA clears a Femasys 510(k) for its diagnostic device for checking the fallopian tubes to confirm permanent birth control placemen...

Lab Group Seeks Congress Help on LDT Rule

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The Association for Diagnostics and Laboratory Medicine raises significant concerns regarding the recent FDA final rule on laborat...