Zydus Pharmaceuticals asks FDA to ensure that Indocin suppositories and their generics meet ICH guidelines and established impurity acceptance criteri...
Rocket Pharmaceuticals says it has reached an agreement with FDA on a pivotal Phase 2 trial of an investigational gene therapy for Dannon Disease.
Eiger Pharmaceuticals says it is shutting down the Phase 3 LIMT-2 trial of peginterferon lambda in patients with chronic hepatitis delta for safety re...
Two Knobbe Martens attorneys say the Supreme Court could clarify the bounds of federal preemption of state tort claims based on drug labels if it take...
The International Society for Pharmaceutical Engineering says FDA should incorporate provisions in an ICH product lifecycle management guideline in an...
FDA clears the Samsung Wellysis units wearable electrocardiography patch, S-Patch Ex.
The White House credits FDA actions in helping to reduce cancer drug shortages.
Abbott recalls its Proclaim and Infinity implantable pulse generators due to complaints from patients who are unable to exit MRI mode.
