Approved
Soleno breaks through with FDA nod for Prader-Willi syndrome treatment Vykat XR
FDA approval, Vykat XR, Prader-Willi syndrome, hyperphagia, Soleno Therapeutics, diazoxide choline
FDA clears Exelixis’ TKI for neuroendocrine tumours
CABOMETYX, cabozantinib, neuroendocrine tumors, FDA approval, Exelixis, tyrosine kinase inhibitor
Wave Life Sciences’ WVE-N531 Shows Promise in Duchenne Muscular Dystrophy Treatment
Duchenne muscular dystrophy (DMD), WVE-N531, exon 53 skipping, Phase II trial, dystrophin expression, muscle health improvement, FDA approval
FDA Approves Blujepa: First New Oral Antibiotic for Uncomplicated UTIs in Nearly 30 Years
Gepotidacin, Blujepa, GSK, uncomplicated urinary tract infections (uUTIs), FDA approval, first-in-class antibiotic
Novartis snags FDA nod for Fabhalta in another kidney disease but leaves room for rival Apellis
Fabhalta, United States Food and Drug Administration, Apellis, Novartis, Approved, C3 G, Proteinuria, pegcetacoplan, Kidney Diseases
J&J advances Stelara succession scheme with FDA nod for Tremfya in Crohn’s disease
Tremfya, United States Food and Drug Administration, Crohn ‘s disease, Approved, CD, J&J ‘s
Alnylam’s Amvuttra Approved for ATTR Cardiomyopathy, Challenging Pfizer and BridgeBio
Amvuttra, vutrisiran, ATTR-CM, FDA approval, RNAi therapeutic, cardiomyopathy
Mineralys Phase 3 blood pressure pill data support potential FDA approval
United States Food and Drug Administration, Launch-HTN, Uncontrolled, Hypertensive disease, Approved
FDA Approves First Treatment for Macular Telangiectasia Type 2 (MacTel)
ENCELTO, revakinagene taroretcel-lwey, MacTel, FDA approval, encapsulated cell therapy, ciliary neurotrophic factor (CNTF)
Jazz Pharmaceuticals to Acquire Chimerix for $935 Million, Gaining Promising Brain Tumor Drug Dordaviprone
Jazz Pharmaceuticals, Chimerix, Acquisition, Dordaviprone, Brain tumor, H3 K27M-mutant diffuse glioma, FDA approval, Oncology pipeline