Intellia Therapeutics starts a rolling BLA submission for its experimental gene-editing therapy lonvoguran ziclumeran, or lonvo-z, as a one-time treatment for hereditary angioedema.
FDA identifies significant deficiencies at BayCare Integrated Service Center, an outsourcing facility in Temple Terrace, FL, following a March inspection.
Intellia Therapeutics starts a rolling BLA submission for its experimental gene-editing therapy lonvoguran ziclumeran, or lonvo-z, as a one-time treatment for hereditary angioedema.
FDA identifies significant deficiencies at BayCare Integrated Service Center, an outsourcing facility in Temple Terrace, FL, following a March inspection.
FDA accepts for priority review a Jazz Pharmaceuticals supplemental BLA for Ziihera (zanidatamab-hrii) for use in combination regimens for first-line treatment of patients with HER2-positive advanced gastroesophageal cancers.
A federal judge dismisses a lawsuit brought by homeopathy advocates and a product distributor challenging FDA’s decision to tighten oversight of homeopathic drugs.
