December 20, 2022
The US Food and Drug Administration (FDA) has requested that Oncopeptides AB withdraw the US marketing authorization for its multiple myeloma drug Pepaxto (melphalan flufenamide), the […]
December 19, 2022
The US Food and Drug Administration (FDA) has approved pafolacianine (Cytalux) for use as an injectable imaging agent for adults with lung cancer. The new approval, […]
December 16, 2022
The US Food and Drug Administration has approved nadofaragene firadenovec-vncg (Adstiladrin), the first gene therapy for adults with bladder cancer. The adenovirus vector based gene therapy […]
December 15, 2022
Today, the US Food and Drug Administration approved several indications and other updates to the label of capecitabine tablets (Xeloda) under the agency’s Project Renewal initiative. […]
December 15, 2022
A biosimilar drug to the tumor necrosis factor inhibitor adalimumab, marketed as Idacio (adalimumab-aacf), has been approved by the Food and Drug Administration for use in […]
December 13, 2022
New more aggressive targets for blood pressure and lipids are among the changes to the annual American Diabetes Association (ADA) Standards of Care in Diabetes — […]
December 13, 2022
The US Food and Drug Administration (FDA) has granted accelerated approval to adagrasib (Krazati) for use in adults with KRAS G12C-mutated locally advanced or metastatic non–small […]
December 9, 2022
The US Food and Drug Administration (FDA) has approved two assays that reliably measure two biomarkers of Alzheimer’s disease (AD) in cerebrospinal fluid (CSF) — beta-amyloid […]
December 8, 2022
The FDA on Thursday authorized bivalent COVID-19 vaccines for children as young as 6 months old who previously received the Moderna vaccine or who have not […]