Fears of heightened scrutiny by the FDA will be calmed by a look at historic rates of complete response letters.
Intercept’s woes have continued as a possible new liver toxicity signal was buried in a regulatory filing. What could this mean?
An analysis of FDA complete response letters does not reveal a big uptick – but the year is not over yet.
The unexpected approval of Vyondys 53 followed an FDA power struggle, and turned on a vague commitment from Sarepta, it has emerged.
Issues with manufacturing, not exactly a new problem for Immunomedics, derail the company’s bid for glory.