Ionis receives U.S. FDA Breakthrough Therapy designation for zilganersen for Alexander disease (AxD)
CARLSBAD, Calif.--(BUSINESS WIRE)--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ...
CARLSBAD, Calif.--(BUSINESS WIRE)-- Ionis Pharmaceuticals, Inc. (IONS) (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug ...
CARLSBAD, Calif.--(BUSINESS WIRE)-- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive topline results from the pivotal study of zilganersen in children and adults living with ...
Ionis Pharmaceuticals is eyeing a new rare disease approval after its antisense oligonucleotide zilganersen successfully improved mobility in patients with the neurological condition Alexander disease ...
A Prescription Drug User Fee Act target date of September 22, 2026 has been set for the application. The Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA ...
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Mutant GFAP disrupts mitochondrial fission in astrocytes, offering insight into Alexander disease
Some brain disorders are straightforward, such as the direct frontal lobe assault of a concussion or traumatic brain injury. Others, like Alexander disease, are akin to guerrilla warfare. Patients ...
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for zilganersen, an ...
– First and only investigational medicine to demonstrate a clinically meaningful and disease-modifying impact on this rare, often fatal neurological condition – – NDA submission planned in Q1 2026 – ...
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