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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

[ Price : $8.95]

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

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. ...

Traveres Filspari Converted to Full Approval

[ Price : $8.95]

FDA grants Travere Therapeutics full approval for Filspari (sparsentan) for slowing kidney function decline in adults with primary...

Info Collection on Drug Supply Security

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection revision entitled Pharmaceutical Distribution Supply Chai...

Guide on Device Patient Preference Information

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Incorporating Voluntary Patient Preference Information over...

Panel to Review Stealth Bio Barth Syndrome NDA

[ Price : $8.95]

Federal Register notice: FDA announces a 10/10 Cardiovascular and Renal Drugs Advisory Committee meeting to review a Stealth BioTh...

GSK Reports Trial Results of Nucala in COPD

[ Price : $8.95]

GSK says data from its Phase 3 MATINEE clinical trial evaluating chronic obstructive pulmonary disease drug Nucala (mepolizumab) m...

Odin Medical AI Colon Polyp Detector

[ Price : $8.95]

FDA clears an Odin Medical (an Olympus subsidiary) 510(k) for what it describes as the first cloud-based artificial intelligence t...