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Federal Register notice: FDA makes available a draft guidance entitled Incorporating Voluntary Patient Preference Information over...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

Eye Product Manufacturer Hit with Warning Letter

[ Price : $8.95]

FDA issues Regenerative Processing Plant a Warning Letter based on a 2023 inspection of the firms Palm Harbor, FL, manufacturing p...

Taenaka Kogyo Inspection Cites 4 Observations

[ Price : $8.95]

An April inspection of Japans Taenaka Kogyo ends in a four-observation Form FDA-483 that cites significant GMP violations.

Biocon Biologics Gets 10-item FDA-483

[ Price : $8.95]

FDA posts a Form FDA-483 issued to Biocon Biologics at the end of a July inspection at the firms Bengaluru, India manufacturing fa...

Patient Preference Info in Product Life Cycle

[ Price : $8.95]

FDA publishes a draft guidance on incorporating voluntary patient preference information in medical device total life cycle regula...