[ Price : $8.95]
Novavax says its Covid-19 vaccine BLA is being held up while FDA seeks to conclude a post-marketing commitment from the company.[ Price : $8.95]
FDA grants CereVasc a breakthrough device designation for its investigational eShunt System and its use in treating communicating ...[ Price : $8.95]
FDA says its Electronic Submission Gateway Next Generation is live and ready to receive submissions.[ Price : $8.95]
Vanda Pharmaceuticals criticizes FDA for wrongly claiming that recent staff cuts and a new commissioner causes it to delay a compa...[ Price : $8.95]
Akeso says its ivonescimab met the primary endpoint in a pivotal Phase 3 trial for the first-line treatment of advanced squamous n...[ Price : $8.95]
FDA warns ICU Medical that its Minneapolis, MN-based Smiths Medical ASD unit is illegally marketing adulterated and misbranded inf...[ Price : $8.95]
Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second year of its voluntary Quality Ma...[ Price : $8.95]
FDA Matters founder Steven Grossman says FDA commissioner Martin Makary and the Trump administration are at a crossroads and need ...