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September 12, 2019
Time is running out on Ned Sharpless’ term as FDA acting commissioner, generating much talk as the administration shows interest in naming a new head for the agency.
September 11, 2019
FDA issued a statement about the importance of reporting adverse events resulting from the use of compounded drugs.
The agency has approved Boehringer Ingelheim’s Ofev (nintedanib), its lung disease drug, for the treatment of patients with systemic sclerosis associated with lung disease.
Xeris Pharmaceuticals has received FDA approval for GVOKE (glucagon), a liquid glucagon for treating hypoglycemia.
September 06, 2019
FDA sent a warning letter to Stemell, Inc. for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice and current good manufacturing practices.
FDA announced it is developing a series of guidance documents to promote methodological patient-focused drug development.
A US District Court judge in Tennessee entered a consent decree of permanent injunction against Basic Reset and Biogenyx after multiple FDA inspections of the companies’ facility found violations of the Federal Food, Drug, and Cosmetic Act.
September 04, 2019
The company has received breakthrough therapy designation for its prophylactic respiratory syncytial virus vaccine candidate for treating adults aged 60 years or older.
September 03, 2019
The multitude of health reform measures emerging on Capitol Hill has accelerated lobbying action across the board, along with campaign donations to candidates from all sides.
September 02, 2019
Industry and regulators seek global system that reduces regional differences.