FDA Related News

Medtronic Enrolls 1st Embrace TDD Patient

Medtronic enrolls the first patients in its Embrace TDD study of the SynchroMed II intrathecal drug delivery system.

Human Drugs

Bridge Biotherapeutics Given Orphan Designation for BBT-877

FDA grants Bridge Biotherapeutics an orphan drug designation for BBT-877, an autotaxin inhibitor that deregulates ATX, an enzyme found to be associate...

Medical Devices

Edwards, Boston Settle all Patent Disputes for $180 Million

Edwards Lifesciences says it is making a one-time payment of $180 million to Boston Scientific as part of a settlement of all outstanding patent dispu...

Biologics

FDA Approves Expanded Adacel Use

FDA approves an expanded indication for Sanofis Adocel as a repeat vaccination delivered eight or more years after the initial vaccination to help pro...

Human Drugs

Eisai/Purdue NDA Filed for Insomnia

Eisai and Purdue Pharma submit an NDA for lemborexant for treating insomnia.

Human Drugs

Draft ANDA Amendment Submission Guidance

FDA issues a draft guidance on amendments and requests for final approval to tentatively approved ANDAs.

Human Drugs

FDA Approves Tevas Generic Seizure Drug

FDA approves a Teva Pharmaceuticals ANDA for the first generic version of Lundbecks Sabril (vigabatrin) 500 mg tablets for treating complex partial se...

Human Drugs

Rare Diseases Drug Development Draft Guidance

FDA issues a revised draft guidance on common issues in drug development for rare diseases.

Medical Devices

FDA Clears Immuno Concepts LKS Tissue Slides

FDA clears an Immuno Concepts 510(k) for the Histofluor Rodent LKS Tissue Slides for manual and Image Navigator use.

Human Drugs

FDA Final Data Integrity Guidance Reviewed

Duane Morris attorneys review key provisions in the FDA final guidance on data integrity and CGMP compliance.