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A rare disease advocacy group tells Congress to increase FDA oversight, warning that inconsistent use of regulatory flexibility an...[ Price : $8.95]
The U.S. Senate Special Committee on Aging raises concerns about FDAs handling of foreign drug manufacturing violations and how th...[ Price : $8.95]
FDA accepts for priority review an Ionis Pharmaceuticals supplemental NDA for olezarsen for treating severe hypertriglyceridemia.[ Price : $8.95]
Fresenius Kabi recalls its Ivenix Large Volume Pump due to a software issue.[ Price : $8.95]
FDA approves a Sanofi and Regeneron Pharmaceuticals BLA supplement for Dupixent (dupilumab) and its use for treating adults and ch...[ Price : $8.95]
FDA issues an early alert about a potentially high-risk problem involving certain heart pump components manufactured by Abiomed, w...[ Price : $8.95]
CDER Division of Applied Regulatory Science (DARS) has published its 2025 Annual Report, highlighting significant research advance...[ Price : $8.95]
Rep. Josh Gottheimer introduces several bills to mark Rare Disease Week.