The latest global regulatory news, changes and updates affecting biopharma, including: Association for Accessible Medicines, Department of Justice, EMA, FDA, Federal Trade Commission, International Coalition of Medicines Regulatory Authorities, SEC, White House, World Health Organization.
The latest global regulatory news, changes and updates affecting biopharma, including: 340B Health, Department of Health and Human Services, FDA, Health Resources and Services Administration, Institute for Clinical and Economic Review, Medicines and Healthcare products Regulatory Agency.
PERTH, Australia – The FDA granted Melbourne-based Neuren Pharmaceuticals Ltd. and San Diego, California-based Acadia Pharmaceuticals Inc. a rare pediatric disease designation for trofinetide for treatment of Rett syndrome, a rare neurodevelopmental congenital central nervous system disorder.
HONG KONG – Cadila Healthcare Ltd. (Zydus Cadila) has won approval for its saroglitazar to be used as the treatment of non-cirrhotic nonalcoholic steatohepatitis (NASH) in India. The green light from the Drug Controller General of India (DCGI) makes saroglitazar the first drug in the world approved for this indication.