BioSpace13h
FDA Presses Pause on Atara’s Programs, Play on Amylyx’s ALS Assets
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a ...
Atara's New Drug Applications Placed on Hold by FDA
Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its ...
Healio10h
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 ...
Business Wire5d
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 ...
Healio7d
FDA clears investigational new drug application for lorundrostat in OSA, hypertension
The FDA approved the phase 2 Explore-OSA trial set to assess the highly selective aldosterone synthase inhibitor, ...
ophthalmologytimes11d
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.
Targeted Oncology7d
FDA Considers TAR-200 in BCG-Unresponsive High-Risk NMIBC
An FDA application for TAR-200 to treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer is under real-time ...
FDA Accepts Arrowhead Pharmaceuticals' Drug Application for Genetic Disease Treatment
Arrowhead Pharmaceuticals said Friday that the Food and Drug Administration accepted the company's new drug application for its treatment of familial chylomicronemia syndrome, a severe and rare ...
JD Supra5d
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 ...
Zacks.com on MSN10h
J&J's Depression Drug Spravato Gets FDA Nod for Monotherapy Use
Johnson & Johnson JNJ announced that the FDA has approved its supplemental new drug application (sNDA), seeking approval for ...
Medscape5d
FDA Approves New ADC for HR+, HER2- Breast Cancer
The US Food and Drug Administration (FDA) has approved datopotamab deruxtecan for the treatment of certain patients with ...
Cure Today8d
FDA Grants Priority Review to Sunvozertinib for EGFR Exon20+ NSCLC
The Food and Drug Administration has accepted and granted priority review to a new drug application for sunvozertinib.