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United Therapeutics asks FDA not to approve a Liquidia NDA for Yutrepia because the sole supplier of active pharmaceutical ingredi...[ Price : $8.95]
A California federal court tosses a shareholder class action suit claiming that AcelRx deliberately used marketing materials for i...[ Price : $8.95]
FDA issues a complete response letter for a Dynavax sBLA for a new indication for its Heplisav-B hepatitis vaccine.[ 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 ...[ Price : $8.95]
Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for made during January, Fe...[ Price : $8.95]
FDA says CTK Biotechs ImmuView Covid-19 Antigen Home Test now has a longer shelf life than previously authorized.[ Price : $8.95]
FDA extends by three months its review of an Ascendis Pharma NDA for TransCon PTH (palopegteriparatide) due to the companys submis...[ Price : $8.95]
FDA approves Baxters expanded indication for parenteral (intravenous) nutritient Clinolipid (lipid injectable emulsion) for use in...