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A detailed Washington Post story explores the pressures on FDA to authorize or approve a Covid-19 vaccine within the next few week...[ Price : $8.95]
CDER says its more extensive testing found NDMA in only eight of 16 metformin samples in which it was found by a private laborator...[ Price : $8.95]
FDA clears a SoftWave Tissue Regeneration Technologies 510(k) for using its SoftWave technology for treating superficial, partial-...[ Price : $8.95]
FDA issues a revised and updated draft guidance on pharmacokinetic study design and analysis for patients with impaired renal func...[ Price : $8.95]
Sen. Ted Cruz and 19 other senators call on FDA to order the abortion drug Mifeprex off the U.S. market.[ Price : $8.95]
FDA accepts for priority review an Athenex NDA for oral paclitaxel and encequidar for treating metastatic breast cancer.[ Price : $8.95]
FDA grants Alphamab Oncology an orphan drug designation for KN046, a recombinant humanized antibody for treating thymic epithelial...[ Price : $8.95]
Three stakeholders say FDA should provide additional clarification on the rules for listing patents in the Orange Book.