Browsing: FDA

The FDA has approved Fayuvi, a gene therapy for Sanfilippo syndrome, a rare inherited disease. The treatment costs nearly $4 million per patient.

The FDA granted accelerated approval for Voceryq, the first plasmid DNA-based immunotherapy for adults with recurrent respiratory papillomatosis, a rare condition caused by HPV.

Most FDA scientists opposed the Trump administration’s move to ease access to unproven peptide drugs favored by Health Secretary Robert F Kennedy Jr.

The Department of Health and Human Services will allow small pharmacies to compound six popular peptides, moving them from the gray market to regulated facilities.

The FDA launched the Neuroscience Advancement and Innovation Nexus to accelerate medical product development for brain conditions, starting with Alzheimer’s prevention.

The FDA approved Hibsago, the first antisense oligonucleotide for chronic hepatitis b treatment, allowing some patients to stop therapy while maintaining viral control.

The FDA has approved the first generic version of Climara Pro, a once-weekly transdermal patch designed for menopause treatment in women with an intact uterus.

The FDA announced the Rare Disease Framework Initiative to create a tailored regulatory approach for rare disease drug development, aiming to accelerate treatments for small patient populations.

The FDA has expanded Anktiva approval to treat BCG-unresponsive bladder cancer in adults with high-grade papillary tumors, marking a new evaluation approach.

The American Academy of Pediatrics has called for a ban on unpasteurized milk sales as the industry sees record growth and recent disease outbreaks alarm public health officials.