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Mineralys Nets Positive Data in Hypertension Drug Studies

[ Price : $8.95]

Mineralys Therapeutics reports positive topline data from its pivotal Launch-HTN Phase 3 and pivotal Advance-HTN Phase 2 trials as...

FDA Clarifies Compounding Policy for GLP-1 Products

[ Price : $8.95]

FDA clarifies its policies for compounders of GLP-1 products for weight-loss and treating diabetes following a court ruling in Tex...

Dexcom Hit With Warning After 2 Inspection

[ Price : $8.95]

Dexcom says it received an FDA Warning Letter following inspections at the companys facilities in San Diego, CA and Mesa, AZ.

FDA Staff Given $25,000 Buyout Offers

[ Price : $8.95]

HHS offers its 80,000 federal employees, including FDA, up to a $25,000 buyout to retire or leave their government employment as p...

FDA Clears Zimmer Persona Knee Implant

[ Price : $8.95]

FDA clears a Zimmer Biomet 510(k) for its Persona Revision SoluTion Femur, a revision knee implant for patients who have sensitivi...

Fresenius Kabi Recalls Ivenix Infusion Software

[ Price : $8.95]

Fresenius Kabi recalls its Ivenix LVP software that is embedded in its Ivenix Infusion System due to reports about certain anomali...

Plus Therapeutics Gets Orphan Statis for Radiotherapy

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FDA grants Plus Therapeutics an orphan drug designation for Rhenium (186Re) Obisbemeda, a radiotherapy for treating leptomeningeal...

FDA Denys Hearing on Vanda Hetlioz Rejection

[ Price : $8.95]

Federal Register notice: FDA makes available its decision to deny a request for a hearing on a CDER recent refusal to approve a Va...

J&J Stops Phase 3 Depression Drug Program

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Johnson & Johnson stops its Phase 3 VENTURA development program evaluating aticaprant as an adjunctive treatment for major depress...

FDA Domestic Inspections Fall, Foreign Rise: Study

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Consultants from Eliquent Life Sciences say most of FDAs drug inspection-based Warning Letters issued in fiscal year 2024 went to ...