Dupilumab Gets Priority Review for COPD With Type 2 Inflammation
The application is supported by data from the randomized, double-blind, placebo-controlled phase 3 BOREAS and NOTUS trials.
Source: clinicaladvisor.com
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Top News In Priority Review Today - Breaking & Trending Today
FDA Grants Review Date For Applied Therapeutics' First Commercial Product For Rare Metabolic Disorder
Applied Therapeutics Inc (NASDAQ:APLT) shares are trading higher on Wednesday after the FDA accepted the filing of the New Drug Application (NDA) for govorestat (AT-007) for Classic Galactosemia. The NDA was granted Priority Review status, and the FDA assigned a Prescription Drug User Free Act (PDUFA) target action date of August 28, 2024. The FDA also noted that it plans to hold an advisory committee meeting to discuss the application. Govorestat was previously granted Pediatric Rare Disease de
Source: yahoo.com
Vyvgart Hytrulo Gets Priority Review for Chronic Inflammatory Demyelinating Polyneuropathy
The FDA accepted for Priority Review the sBLA for the SC formulation of efgartigimod alfa plus hyaluronidase-qvfc for the treatment of CIDP.
Source: neurologyadvisor.com
Axatilimab Gets Priority Review for Chronic Graft-vs-Host Disease
The application is supported by data from the phase 2 AGAVE-201 study.
Source: empr.com
FDA approves first medication to treat severe frostbite
Williamsport, Pa. — A new treatment for frostbite has just been approved by the federal Food and Drug Administration , but local doctors say prevention is still the best medicine.
Source: northcentralpa.com