A Florida federal judge sentences the founder of Blackstone Labs to 54 months in prison and orders him to forfeit $2.9 million for his role in a consp...
Bloomberg News reports that Pfizer/BioNTech are submitting rolling data for an EUA for Covid-19 vaccinations for kids between six months and four year...
Novavax has submitted an emergency use authorization for NVX-CoV2373, its protein-based Covid-19 vaccine candidate for adults 18 years of age and olde...
FDA issues sterile drug product maker Johnson Memorial Cancer Center a Form FDA-483 after a 10/2021 inspection cited GMP deficiencies.
A just-released CDRH annual report says it was able to grant marketing authorizations for 103 novel devices last year, despite being one of the busies...
FDA commissioner nominee Robert Califf agrees to significant ethics commitments in a move to secure Senate support for his nomination.
FDA grants full approval to Modernas Covid-19 vaccine under the name Spikevax for use in individuals 18 years of age and older.
FDA posts four draft guidances on the use of real-world data and real-world evidence in regulatory decision-making, covering topics related to data so...