FDA warns Ionogen that its Ionopure Skin & Hands product that the company is marketing to treat Covid-19 is a misbranded unapproved new drug that cann...
FDA releases statistics from an Essure follow-up study showing that patients experienced more issues than those who had laparoscopic tubal ligation.
Mylan recalls one lot of daptomycin for injection, 500 mg/vial, due to particulate matter found in one single-dose vial.
Federal Register notice: FDA seeks comments on a proposed information collection entitled Study of Multiple Indications in Direct- to-Consumer Televis...
FDA sends Merck and Eisai a complete response letter on their request for accelerated approval of an NDA for Keytruda (pembrolizumab) plus Lenvima (le...
Federal Register notice: FDA sends to OMB a proposed information collection entitled Healthcare Provider Perception of Boxed Warning Information Surve...
The Microbiome Therapeutics Innovation Group petitions FDA to finalize a 2016 draft guidance to specify that sponsors and manufacturers of commercial-...
Politico reports that many drug companies have been raising prices during the coronavirus pandemic.