Managed Healthcare Executive11h
FDA and EMA Accepts Applications for New Nusinersen Regimen
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower ...
Business Wire6d
Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
JD Supra6d
FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
Monthly Prescribing Reference16h
FDA Extends Review of Elamipretide for Barth Syndrome
The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elamipretide for the treatment of Barth syndrome, a rare genetic disorder.
Medscape3d
Introduction to the New Prescription Drug Labeling by the Food and Drug Administration
The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA.
ophthalmologytimes12d
FDA accepts revised supplemental New Drug Application for IZERVAY
The application was refiled following a December 20, 2024, meeting between the US Food and Drug Administration and Astellas.
Yahoo Finance25d
Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients With Hypercortisolism
has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous ...
Healio1d
FDA approves Spravato as monotherapy for adults with major depressive disorder
The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as ...