Lexeo's Friedreich Ataxia Treatment Accelerates FDA Review
Lexeo Therapeutics' gene therapy, LX2006, is moving faster toward FDA approval for Friedreich's ataxia cardiomyopathy.
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Arcus Biosciences’ Casdatifan Drug Scores a 'Home Run'!
Casdatifan data is a "home run"! Survival without disease worsening hit 12 months, which is double the competitor's time.
Skye Bioscience Nimacimab Study Fails Primary Endpoint
Skye Bioscience reports mixed results for its weight-loss drug nimacimab: it failed alone due to suboptimal dosing, but adding it to semaglutide (Wegovy/Ozempic) resulted in significant extra weight loss without increasing common stomach or mental side effects.
Gilead's Biktarvy Patent Extended to 2036
Gilead Sciences settled lawsuits with generic manufacturers, securing market exclusivity for Biktarvy until April 2036.
Spruce Biosciences Stock Soars after Receiving FDA Breakthrough Therapy Status
FDA gave a new drug Breakthrough status to treat fatal Sanfilippo Syndrome B (MPS IIIB), potentially stopping brain damage in kids.
Arcutis New Steroid-Free Eczema Cream Approved for Young Children (Ages 2–5)
The FDA approved ZORYVE (roflumilast) cream 0.05% for kids aged 2 to 5 with mild to moderate atopic dermatitis (eczema).