HansGarrincha schreef op 5 april 2019 17:22:
Iemand een mening over het feit dat Gilead een PRV heeft gebruikt voor Descovy...Hebben ze NOG een PRV op de plank liggen???
OSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 5, 2019-- Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV. A Priority Review voucher was submitted with the filing, leading to an anticipated review time of six months.