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The FDA issued a complete response letter (CRL) to Sanofi for sutimlimab, an investigational monoclonal antibody for treating hemolysis in adults with the rare autoimmune condition, cold agglutinin disease. Read More
The FDA published final guidance designed to help drug compounders recognize, prevent and respond to insanitary conditions at their facilities. Read More
The FDA’s Office of Regulatory Affairs (ORA) has determined that general and prioritized inspections will remain preannounced for the foreseeable future in order to ensure the safety of those involved during the pandemic, according to a regulatory official. Read More
The FDA is very likely to grant Emergency Use Authorization (EUA) for Pfizer’s COVID-19 vaccine following a 17-4 advisory committee vote (with one abstention) Thursday in support of emergency clearance, meaning vaccinations of high-risk patients could start as soon as this weekend. Read More
The advocacy group Public Citizen said Wednesday that it had written to the HHS’ Office of Inspector General urging it to “investigate the unprecedented and inappropriate close collaboration” between the FDA and Biogen over the company’s biologics license application (BLA) for approval of the potential blockbuster Alzheimer’s drug aducanumab. Read More
Azurity Pharmaceuticals downplayed the serious risks and overstated the benefits of its leukemia drug Xatmep (methotrexate) oral solution in the text of a promotional email sent to healthcare professionals, according to a Nov. 24 “untitled letter” from the agency’s Office of Prescription Drug Promotion (OPDP). Read More
The FDA is working on a report tied to a two-day meeting this week to discuss its pilot program on pharmaceutical supply chain interoperability, as well as other efforts to modernize the drug supply chain in the U.S. It has not set a release date for the report. Read More
A cystic fibrosis (CF) advocacy group has levied a formal complaint with the United Nations (UN), charging that Vertex Pharmaceuticals is violating the world body’s guidelines by unfairly pricing its CF drugs and not ensuring widespread equitable access. Read More
FDA today said it is publishing two guidances focused on maintaining compliance with the agency’s mislabeling regulations as well as how best to name new drugs so that consumers can avoid medication errors. Read More
An FDA Emergency Use Authorization (EUA) could come as soon as this weekend for Pfizer/BioNTech’s COVID-19 vaccine, with the vaccine advisory committee set to meet tomorrow to discuss the agency’s 53-page analysis concluding that the two-dose regimen met its strict EUA requirements. Read More