Pandemic Perspectives: US FDA ACTT’s On Its Faith In Randomized Trials With Veklury Approval Despite WHO Study
US FDA has not deviated from its bedrock trust in the value of ‘statistically reliable’ endpoints amidst the COVID-19 pandemic, the Pink Sheet’s Drug Review Profile of Gilead’s Veklury shows.
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Keeping Track: First COVID Vaccine BLA Kicks Off; Oncology Submissions From Hutchmed, Takeda And Shorla
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
India stops remdesivir exports amid steep surge in COVID-19 cases, while licensees of Gilead’s antiviral take multiple measures to ramp up production to meet local demand. One badly affected state stresses the need to stem panic given the limitations of the treatment, even as some non-licensees of the drug apparently seek to contribute to supplies.