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New guidance from the FDA that would set tougher conditions for COVID-19 vaccine Emergency Use Authorizations (EUAs) remains under White House review, and it is unclear when — or if — it may be released. Read More
Gilead Sciences has resumed direct distribution to hospitals of its antiviral drug remdesivir, after HHS decided that the federal government no longer has to control the process because there is a sufficient supply to treat COVID-19 patients. Read More
Pending FDA approval or authorization, the HHS Secretary said Friday he anticipates having enough vaccine manufactured by the end of 2020 to vaccinate certain priority populations and enough to vaccinate all Americans by March to April 2021. Read More
Catalyst Pharmaceuticals saw its lawsuit against the FDA and competitor Jacobus Pharmaceutical dismissed this week by a federal court in Florida. Read More
In recent years, the FDA has tended to approve new opioid drugs “on the basis of pivotal trials of short or intermediate duration, often in narrowly defined pain populations of patients who could tolerate the drug,” according to a new study led by researchers at the Johns Hopkins School of Public Health. Read More
President Trump has signed a short-term funding bill that keeps the government up and running through Dec. 11. The continuing resolution does not contain any new FDA funding and means the agency will operate using fiscal 2020 funding levels through that date. Read More
Former FDA Commissioner Scott Gottlieb strongly defended the agency’s approach to getting a vaccine out to the public in the shortest amount of time, criticizing the Trump administration’s apparent attempt to derail a planned guidance the president believes could reduce the chance of having a proven vaccine before the November election. Read More