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Intellia Therapeutics starts a rolling BLA submission for its experimental gene-editing therapy lonvoguran ziclumeran, or lonvo-z,...[ Price : $8.95]
FDA identifies significant deficiencies at BayCare Integrated Service Center, an outsourcing facility in Temple Terrace, FL, follo...[ Price : $8.95]
FDA accepts for priority review a Jazz Pharmaceuticals supplemental BLA for Ziihera (zanidatamab-hrii) for use in combination regi...[ Price : $8.95]
A federal judge dismisses a lawsuit brought by homeopathy advocates and a product distributor challenging FDAs decision to tighten...[ Price : $8.95]
Concerns that political pressure could undermine the U.S. drug approval system intensify this week after a new White House directi...[ Price : $8.95]
FDA plans to unveil a significant shift in how clinical trials are conducted and regulated, announcing major steps to implement re...[ Price : $8.95]
Galaxy Therapeutics has submitted the final module of a PMA for its SEAL device, a treatment designed for patients with wide-neck ...[ Price : $8.95]
CDER's Office of Compliance releases a new annual report showing that it expanded enforcement and oversight activities in 2025.