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.
Regeneron says it will submit an odronexamab trial protocol amendment to FDA in hopes of resuming trial enrollments in 2021.
Attorneys Dick Dean and Emmanuel Sanders see the possibility that five Supreme Court justices would vote to overturn Wyeth v. Levine.
FDA approves an Athenex NDA for Klisyri (tirbanibulin) for the topical treatment of actinic keratosis on the face or scalp.