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An expert panel of the Centers for Disease Control and Prevention (CDC) is meeting today to review blood-clot incidents reported in a handful of patients who received Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine. Read More
The agency said the sponsors failed to respond to a Sept. 25, 2020, Federal Register notice that offered an opportunity to seek a hearing on the matter. Read More
The institute has invited comments by April 26 and said it may change its recommendations when its appraisal committee meets to consider the responses and prepare the final appraisal document. Read More
Eli Lilly has revised its supply deal with the U.S. government to focus on distributing the company’s COVID-19 antibody bamlanivimab along with another antibody, etesevimab — a combination that has proven to be effective against variant strains of the Sars-CoV-2 virus which causes COVID-19 infections. Read More
The FDA has selected Patrizia Cavazzoni as permanent director of the Center for Drug Evaluation and Research (CDER), a position previously held for many years by Acting Commissioner Janet Woodcock. Read More
The U.K.’s National Institute for Health and Care Excellence (NICE) has issued a preliminary rejection of Bristol-Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab) as a combination treatment for lung cancer in as-yet untreated patients. Read More
Emergent BioSolutions’ beleaguered Baltimore, Md., facility, which Johnson & Johnson has taken over to exclusively produce its vaccine, may be cleared to start shipping out J&J doses before the month is over, according to the White House’s COVID-19 response leader. Read More
The Biden administration has sent a budget proposal to Congress, outlining its spending priorities for fiscal year 2022, but it sheds almost no light on the president’s plans to fund FDA initiatives. Read More
The FDA has released minutes from its meetings in early 2021 with industry on PDUFA reauthorization, discussions that focused on the agency’s Sentinel drug surveillance system and proposed Risk Evaluation and Mitigation Strategies (REMS) assessments. Read More
The commission is inviting comments on the roadmap by April 27, but a public consultation on the strategic plan will continue through the end of this year. Read More
Companies who wish to participate in the ILAP must apply for an “Innovation Passport” and provide details of why their product should be considered for the pathway. Read More