FDA warns Washington Homeopathic Products about CGMP violations in its manufacturing of unapproved new drugs.
Biogen says it has filed a BLA with FDA for aducanumab to reduce the clinical decline of Alzheimers disease.
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...
FDA warns Indias Vega Life Sciences about CGMP deviations in the production of active pharmaceutical ingredients.