Federal Register notice: FDA withdraws the approval of Xellia Pharmaceuticals ANDA for bacitracin for injection after the company requested that it be...
Six stakeholders comment on an FDA draft guidance on the CDRH Voluntary Improvement Program for medical device manufacturers.
Intercept Pharmaceuticals says it will resubmit an NDA to FDA for its obeticholic acid to treat patients with liver fibrosis due to nonalcoholic steat...
FDA says a Getinge USA anesthesia system recall due to cracked or broken suction power switches is Class 1.
Mylan recalls one batch of unbranded insulin glargine pens due to the potential for some pens to be missing the label.
FDA publishes two draft guidances revising previous Drug Supply Chain Security Act guidances.
FDA warns five companies that they are illegally distributing kratom products that are unapproved new drugs.
FDA lifts its clinical hold on Vertex Pharmaceuticals VX-880 stem cell therapy for type 1 diabetes.