Robert Califf’s second tenure as FDA commissioner already feels different from the first, thanks to a national shortage of infant formula – and an abundance of questions about what FDA could have done to prevent it.
US Food & Drug Administration Commissioner Robert Califf’s was sworn in earlier this year with an unsurpassed resume for the job: he had done it before.
That experience from the last year of the Obama Administration meant that Califf had direct, first-hand experience with what it...
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
