The Government Accountability Office reports on regenerative medicine and advanced therapies workforce and education/training needs.
A new White House Office of Science and Technology Policy (OSTP) report lists 10 bold goals for the U.S. biotechnology and biomanufacturing.
CDRH director Jeff Shuren tells an Alliance for Stronger FDA Webinar that cybersecurity is one of the biggest concerns that keeps him up at night.
FDA approves a Cidara Therapeutics and Melinta Therapeutics NDA for Rezzayo (rezafungin for injection) for treating candidemia and invasive candidiasi...
FDA issues AbbVie a complete response letter for ABBV-951 (foscarbidopa/foslevodopa) for treating motor fluctuations in adults with advanced Parkinson...
FDA says events involving squamous cell carcinoma in the scar tissue (capsule) that forms around breast implants should be reported to a registry deve...
FDA warns Procter & Gamble (P&G) about unresolved contradictory information in the electronic listing for one of its Nyquil products and the product l...
FDA grants Incyte accelerated approval of its BLA for Zynyz (retifanlimab-dlwr) for treating adults with metastatic or recurrent locally advanced Merk...
