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Public Citizen calls for publication of federal contracts with five leading candidates to manufacture a Covid-19 vaccine, all of w...[ Price : $8.95]
India-based Aurobindo Pharma says that a recent FDA inspection at its Dayton, NH, AuroLife Pharma unit resulted in a Form 483 citi...[ Price : $8.95]
A lengthy Politico article sees the return of CBER director Peter Marks to full-time FDA duty from Operation Warp Speed as one exa...[ Price : $8.95]
FDA issues a compliance guide for inspections of CDER-led and CDRH-led combination products.[ Price : $8.95]
FDA accepts for review a PharmaEssentia BLA for ropeginterferon alfa-2b (P1101), a novel pegylated interferon intended for treatin...[ Price : $8.95]
FDA approves a Merck NDA for Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial ...[ Price : $8.95]
FDA extends by three months its review of a Novartis supplemental BLA for ofatumumab (OMB 157), a self-administered, targeted B-ce...[ Price : $8.95]
Federal Register notice: FDA posts additional draft and revised draft product-specific guidances on bioequivalence study designs t...