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FDA approves Allecra's combination antibiotic Exblifep for complicated UTIs

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

Allecra Therapeutics receives FDA approval for treatment targeting severe UTIs

Allecra Therapeutics, a biopharma company developing novel therapies to combat antibiotic resistance, has received FDA approval for its treatment tackling ‘complicated’ urinary tract infections (UTIs).

Vertex's Kalydeco Gets CHMP Positive Opinion For Label Expansion To Cystic Fibrosis In Infants

CSL Vifor: Sparsentan Receives Positive CHMP Opinion For Treatment Of IgA Nephropathy