Federal Register notice: FDA makes availability of an over-the-counter monograph proposed order entitled Amending Over-the-Counter (OTC) Monograph M02...
Federal Register notice: FDA revokes the emergency use authorizations for three Covid-19 tests after the companies requested such because the tests ar...
The CDER Office of Generic Drugs revises its scientific priorities as part of its user fee performance goals through 2022.
FDA approves an Amgen supplemental BLA for Repatha (evolocumab) injection as an add-on treatment to diet alone or together with certain other therapie...
FDA grants Genmab and Seagen accelerated approval for their BLA for Tivdak (tisotumab vedotin-tftv), an antibody-drug conjugate for treating certain a...
FDA requires additional conditions of authorization for many molecular, antigen, and serology Covid tests to keep up with emerging mutations.
Federal Register notice: FDA announces a 12/2 Oncologic Drugs Advisory Committee meeting that will panel hear certain updates on NDAs approved under a...
Cordis recalls its Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands due to the potential for the bands to move or dislodge.