The expiration of the FDA’s paediatric priority review voucher programme is creating uncertainty for rare disease drug ...

On a recent call with analysts at BMO Capital Markets, a “former director” at the FDA’s Center for Biologics Evaluation and ...

Novavax’s closely watched COVID-19 vaccine is on track for full approval after additional discussions with the Food and Drug ...

Formulated, Science-Backed Supplements Trusted by Thousands-And See Why Advanced BioNutritionals Sets the Gold Standard in ...

Mursla Bio, a leader in Extracellular Vesicle (EV) science on a mission to significantly improve cancer outcomes for at-risk ...

Significant proposed regulatory changes within the U.S. Food and Drug Administration (FDA), along with large layoffs that ...

Medical device maker ICU Medical changed the designs of infusion pumps made in Minnesota without properly clearing important ...

The potential dangers of these food dyes have been spoken about for years. Here's everything parents need to know.

Key steps for pharmaceutical companies to meet FDA’s upcoming nitrosamine testing requirements and ensure product safety.

Mursla Bio, a Cambridge UK and Boston US leader in Extracellular Vesicle (EV) science, has received FDA approval for its lead ...

The FDA cleared the launch of a Phase 1 clinical trial to test cell therapy XS-228 in people with amyotrophic lateral ...