Four drug companies offer general and specific comments on the FDA framework for assessing drug-drug interactions for therapeutic proteins.
FDA accepts for review a Genentech BLA for a subcutaneous formulation of Herceptin (trastuzumab) and its use in FDA-approved breast cancer indications...
Analysts review judge Brett Kavanaughs Appeals Court decisions involving FDA issues.
An FDA study indicates that addition of cyclin-dependent kinases 4/6 to endocrine therapy helps all patients with estrogen receptor-positive HER2-nega...
A Nikansen Center white paper calls on FDA and Congress to refocus the agencys drug approval process to use tiered categories of approval of products ...
FDA orders safety labeling changes to fluoroquinolone antibiotics to highlight potential mental health side effects.
FDA commissioner Scott Gottlieb describes the benefits of a new medical data system FDA is proposing in its FY 2019 budget request.
Federal Register notice: FDA seeks comments on an information collection extension for Postmarketing Adverse Drug and Biological Product Experience Re...