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The European Medicines Agency (EMA) has expanded its recommendations for compassionate use of Gilead Sciences’ remdesivir for patients with severe COVID-19. Read More
HHS has not yet used its new authority under the 21st Century Cures Act to recruit more senior biomedical scientists for the FDA and other agencies, the Government Accountability Office said in a new report released Friday. Read More
Maryland Gov. Larry Hogan last week vetoed legislation that would have funded the state’s Prescription Drug Affordability Board, an independent body established last year to evaluate costly drugs and set price caps. Read More
Following widespread criticism of the federal government’s handling of COVID-19 treatment remdesivir, HHS released details on Saturday of its distribution plan of the drug, and said states will make the final call on which hospitals get the drug. Read More
Three of the nation’s top medical experts heading up the nation’s response to COVID-19 are now in quarantine after being exposed to the coronavirus. Read More
The Office of Special Counsel (OSC) has recommended that Rick Bright be temporarily reinstated to his position as director of HHS’ Biomedical Advanced Research and Development Authority. Read More
Sponsors of drugs to treat or prevent cytomegalovirus (CMV) disease in organ or stem cell transplant patients may use CMV blood levels (CMV viremia) as a validated surrogate endpoint, according to a guidance the FDA finalized last week. Read More
Alexion has agreed in principle to settle with the Securities and Exchange Commission over an investigation into the company’s alleged bribery of foreign governments. Read More
How the federal government is handling the distribution of Gilead’s remdesivir for treatment of COVID-19 patients is sparking outrage and sharp criticism from physicians’ groups and doctors across the nation. Read More
The FDA accepted the BLA for the drug in February for priority review, and the agency was originally expected to approve the drug by Aug. 17, 2020. Read More
The former director of HHS’s Biomedical Advanced Research and Development Authority (BARDA) has filed a whistleblower complaint claiming he was removed from his role as head of the federal vaccine development agency in part for pushing for a more aggressive response to COVID-19. Read More
To keep prescription drugs moving smoothly through the supply chain during the pandemic, the FDA released emergency final guidance exempting certain COVID-19 products from tracing and identification requirements. Read More