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The Microbiome Therapeutics Innovation Group petitions FDA to finalize a 2016 draft guidance to specify that sponsors and manufacturers of commercial-...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.
Federal Register notice: FDA determines that Mylans Zovirax (acyclovir) oral capsule, 200 mg, was not withdrawn from sale for reasons of safety or eff...
FDA says it wants to hear from stakeholders who intend to participate in monthly online consultation meetings during reauthorization negotiations for ...