The FDA's vaccines advisors have voted in favour of extending the use of mRNA-based COVID-19 vaccine from Moderna and Pfizer/BioNTech to include children from the ages of six months.
Manufacturing problems wreaked havoc with Mallinckrodt's first attempt to secure FDA approval of its treatment candidate terlipressin for hepatorenal syndrome (HRS), but the drugmaker is ha
There's a growing body of evidence that digital therapeutics (DTx) can complement other therapies for a wide range of health conditions, reducing costs and improving patient engagement, but
bluebird bio started last week on tenterhooks, as FDA advisors cast their eyes over data for two gene therapy candidates that are key to its future as a commercially viable concern.
The FDA may have safety concerns abut bluebird bio's gene therapy for rare, fatal disease cerebral adrenoleukodystrophy (CALD), but its advisors believe its benefits far outweigh the risks.
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.