FDA approves combination therapy for blurry vision
The FDA has approved Yuvezzi (carbachol and brimonidine tartrate), a once-daily eye drop to treat presbyopia in adults. Presbyopia is...
FDA
FDA approves $2.59 million gene therapy for SMA
The FDA has approved Itvisma (onasemnogene abeparvovec-brve) to treat children two years and older, teens, and adults living with spinal...
FDA Removes Black Box Label for Menopause Hormone Replacement Therapy
The FDA has removed the black box label for hormone replacement therapy (HRT) used to address menopause symptoms, according to...
FDA Reviewing New Combination Therapy for Patients with MIBC
Muscle-invasive bladder cancer, representing approximately 25% of all bladder cancer cases, is typically managed with radical cystectomy combined with cisplatin-based...
FDA Delays Approval of Replimune’s Melanoma Therapy Despite Promising Trial Results
For now, the FDA has denied approval today of a new melanoma treatment developed by Replimune. The company’s lead drug...
Capricor’s DMD Cell Therapy Faces FDA Setback
The developer of a new cell therapy for Duchenne muscular dystrophy (DMD) says it will continue to push for FDA...
Lykos CEO steps down following FDA rejection of MDMA therapy
Navigate the healthcare industryHealthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers...
Congressmembers urge FDA to approve Lykos’s MDMA therapy
Congress rarely agrees on anything, but one issue they recently seemed to align on is MDMA.Eighty members of Congress wrote...
FDA approves two gene therapies for sickle cell, bringing hope to thousands with the disease
CNN — The US Food and Drug Administration approved two gene-based treatments for sickle cell disease Friday, including the first...
