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Indica Labs Digital Pathology Platform Cleared

[ Price : $8.95]

FDA clears an Indica Labs 510(k) for HALO AP Dx, a digital pathology platform that the company says enables slides to be reviewed ...

Animal Drug Regs Amended for Approvals

[ Price : $8.95]

Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for made during January, Fe...

Expiry Dates Extended on CTK Bios Covid Tests

[ Price : $8.95]

FDA says CTK Biotechs ImmuView Covid-19 Antigen Home Test now has a longer shelf life than previously authorized.

Ascendis Pharma NDA Review Extended

[ Price : $8.95]

FDA extends by three months its review of an Ascendis Pharma NDA for TransCon PTH (palopegteriparatide) due to the companys submis...

CGMP Violations in Grupo Contract Test Lab

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FDA warns Uruguays Grupo Quimico SRL about CGMP violations in its work as a contract testing laboratory for drug companies.

Day One Bio Granted Pediatric Voucher

[ Price : $8.95]

Federal Register notice: FDA announces that it issued Day One Biopharmaceuticals a priority review voucher for its recently approv...

FDA Clears Qiagens Respiratory Panel Plus

[ Price : $8.95]

FDA clears a Qiagen 510(k) for the QIAstat-Dx Respiratory Panel Plus syndromic test for clinical use in diagnosing upper respirato...

FDA Warns Westwood Labs on CGMP Violations

[ Price : $8.95]

FDA warns Azusa, CA-based Woodward Laboratories about CGMP violations in its production of finished drugs.

Pull Yutrepia Tentative Approval: Petition

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United Therapeutics asks FDA not to approve a Liquidia NDA for Yutrepia because the sole supplier of active pharmaceutical ingredi...

Federal Court Dismisses AcelRx Pharms Suit

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A California federal court tosses a shareholder class action suit claiming that AcelRx deliberately used marketing materials for i...