FDA accepts for review a Phathom Pharmaceuticals NDA for vonoprazan as a treatment for adults in healing all grades of erosive esophagitis and relief ...
FDA publishes a question-and-answer guidance for small entities on the provisions in the 2020 final rule on prescription drug importation.
Federal Register notice: FDA extends the comment period on a proposed rule on national standards for licensure for wholesale drug distributors that pu...
Federal Register notice: FDA revokes the Emergency Use Authorization (EUA) issued to Clinical Research Sequencing Platform LLC at the Broad Institute ...
FDA sends Nymox Pharmaceutical a Refusal to File letter for its NDA for fexapotide triflutate for treating benign prostatic hyperplasia, requesting lo...
FDA accepts for priority review a CSL Behring BLA for etranacogene dezaparvovec, an investigational gene therapy for treating adults with hemophilia B...
The Informed Consent Action Network says FDA should revoke the EUA for Pfizers Covid vaccine in children ages 12-15 and not approve an EUA for Moderna...
FDA cautions Santhigram Kerala Ayurvedic Co. of U.S. that it is marketing unapproved new drugs, including two it says will treat Covid-19.