Regulatory rejection flurry does not make a storm
Fears of heightened scrutiny by the FDA will be calmed by a look at historic rates of complete response letters.
Shedding light on Intercept’s opaque disclosure
Intercept’s woes have continued as a possible new liver toxicity signal was buried in a regulatory filing. What could this mean?
Has 2020 been a big year for regulatory knockbacks?
An analysis of FDA complete response letters does not reveal a big uptick – but the year is not over yet.
Internal FDA documents reveal a familiar story for Sarepta
The unexpected approval of Vyondys 53 followed an FDA power struggle, and turned on a vague commitment from Sarepta, it has emerged.
US regulator wipes the smile off Immunomedics’ face
Issues with manufacturing, not exactly a new problem for Immunomedics, derail the company’s bid for glory.
