FDA approves an Aveo Oncology NDA for Fotivda (tivozanib) for treating adults with relapsed or refractory advanced renal cell carcinoma who have recei...
FDA announces a three-day Oncologic Drugs Advisory Committee meeting to discuss the continued approval of six indications associated with three monocl...
FDA releases revisions to four sections of labeling for ViiVs Triumeq and Dovato.
A Parenteral Drug Association article explores how FDA is supporting advanced drug manufacturing techniques.
Reuters details the story of a Lilly human resources officer at the firms Branchburg, NJ, facility who claims company officials ignored her reports of...
Sagent Pharmaceuticals recalls three lots of phenylephrine hydrochloride injection, USP (10 mg/mL) due to sterility concerns.
FDA clears a Qardio 510(k) for its QardioCore ambulatory electrocardiogram device for holter monitoring applications, including its use with a cloud-b...
Nine FDAers say FDA is doing better accounting for sex and gender differences in drug development.