FDA releases the FDA-483 detailing 15 inspection observations from an inspection at Advanced Nutriceuticals, a sterile drug product producer.
EMD Serono suggests ways to improve an FDA discussion paper on communicating cybersecurity vulnerabilities to patients.
Federal officials report to the media that Pfizer is experiencing some vaccine manufacturing issues.
Gilead Sciences and Galapagos abandon the U.S. development of Jyseleca (filgotinib) for Rheumatoid Arthritis after a recent meeting with FDA to discus...
FDA warns Desert Alchemist it is selling misbranded and unapproved new drugs through its Etsy Web site.
FDA issues an emergency use authorization for Ellumes Covid-19 Home Test, the first over-the-counter fully at-home diagnostic test for Covid-19.
FDA advisory committee briefing information confirms that Modernas investigational Covid-19 vaccine (mRNA-1273) efficacy in preventing Covid-19 was 94...
FDA says JC Ayur Life is marketing a misbranded unapproved new drug as an herbal supplement.