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FDA approves a Sunovion Pharmaceuticals NDA for Lonhala Magnair (glycopyrrolate) inhalation solution (25 mcg twice daily) for the ...[ Price : $8.95]
Senator Joe Manchin (D-WV) calls on FDA to adopt three policy changes through its Opioid Policy Steering Committee to reduce unnec...[ Price : $8.95]
A CVM report shows a decrease in antimicrobials sales from 2015 through 2016.[ Price : $8.95]
FDA issues a draft guidance to help sponsors use a possible new approach to developing drugs to treat pediatric rare diseases.[ Price : $8.95]
FDA releases a FDA-483 with seven observations from an inspection at Indias Glenmark Pharmaceuticals.[ Price : $8.95]
FDA approves a Novo Nordisk NDA for Ozempic (semaglutide) injection 0.5 mg and 1 mg, a once-weekly glucagon-like peptide receptor ...[ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled Use of Serological Tests to Reduce the Risk of Transmission of Tr...[ Price : $8.95]
CDRH UDI regulatory policy analyst Christina Savasaar says two key changes were made between draft and final guidances on UDI dire...