News FDA eyes shake-up of swift approval pathway in cancer Regulator wants more use of randomised controlled trials rather than open-label studies.
Oncology Optimised cancer drug dosing - FDA guidelines’ quantum leap Dose optimisation guidance for clinical trials was released by the FDA this January.
News Gilead claims first FDA nod for a hepatitis D therapy At its second attempt, Gilead has won FDA approval for chronic hepatitis D virus drug Hepcludex, four years after it was cleared in the EU.
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