FDA Review posts product approval for the week ending 9/24/2021.
Armstrong Medical recalls its Amsorb Plus Prefilled G-Can 1.0L due to reports that some canisters have difficulties with gas flow that may cause a red...
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...