Former FDA Commissioner David Kessler is set to become Operation Warp Speed’s new chief science officer as just a single day remains until the Biden presidency takes up the mantle…
Participants who received a full two-shot regimen in Moderna’s phase 1 vaccine trial are being given the option to receive a third booster shot through a new clinical trial in…
Another last-minute Trump administration policy was issued at the end of last week by HHS that requires five-year, renewable term limits for directors of all agencies under the department, including…
AstraZeneca (AZ), Sanofi and Eli Lilly have each filed lawsuits against HHS, arguing the federal government can’t force them to provide 340B drug discounts to contract pharmacies. Source: Drug Industry…
Most of the 53 novel drugs approved by the FDA in 2020 were reviewed through at least one expedited approval process, the agency said in a report on the year.…
Medicare Part D pays twice as much on average for hundreds of drugs as the Department of Veterans Affairs (VA), mostly because VA negotiates prices directly with drugmakers, the Government…
The COVID-19 pandemic has brought out many of the FDA’s strengths, including its commitment to science-based decisionmaking, according to a new report on the agency’s Pandemic Recovery and Preparedness Plan…
FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving…
Internal European Medicines Agency (EMA) documents on pending approvals of COVID-19 vaccines were hacked and leaked online, the agency said last week. Source: Drug Industry Daily
The FDA has issued a final guidance recommending that devicemakers include more specific information in the labeling of laparoscopic power morcellators (LPMs) on the risk of spreading benign uterine tissue…