FDA approves an AstraZeneca NDA for Bydureon (exenatide extended-release) for injectable suspension as an add-on therapy to basal insulin in adults wi...
Industria Farmacutica Andrmaco (Toluca, Mexico) recalls topical drug product Pasta De Lassar Andromaco zinc oxide diaper rash treatment after an FDA l...
Stakeholders ask FDA for changes to a draft guidance on CLIA and 510(k) waivers.
Federal Register notice: FDA issues an order withdrawing approval of ANDAs for certain prescription laxatives with the active ingredient polyethylene ...
FDA and the International Medication Safety Network announce a 6/19-20 international summit on medication safety issues.
FDA approves an Abiomed PMA for its expanded Impella CP heart pump with SmartAssist.
Three U.S. senators send a letter to Tri-Source Pharma CEO Robert DiCrisci, asking for an explanation on why a 40-year-old, off-patent cancer drug, lo...
Promius Pharma files an NDA New for its migraine candidate DFN-02, an intranasal formulation of sumatriptan 10 mg and Aegis Therapeutics permeation-en...