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Pull Yutrepia Tentative Approval: Petition

[ Price : $8.95]

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

[ Price : $8.95]

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

Complete Response Letter for 4-Dose Heplisav-B

[ Price : $8.95]

FDA issues a complete response letter for a Dynavax sBLA for a new indication for its Heplisav-B hepatitis vaccine.

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

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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

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

FDA OKs Expanded Clinolipid Use

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FDA approves Baxters expanded indication for parenteral (intravenous) nutritient Clinolipid (lipid injectable emulsion) for use in...

Respironics Recall of Trilogy Evo Ventilators

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Philips Respironics recalls (Class 1) its Trilogy Evo continuous ventilator devices due to a software issue that may cause a power...

Novo Nordisk Filing BLA for Hemophilia A Drug

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Novo Nordisk says it will seek FDA approval by the end of the year for Mim8, its next-generation Factor 8a mimetic bispecific anti...