FDA approves an expanded indication for Sanofis Adocel as a repeat vaccination delivered eight or more years after the initial vaccination to help pro...
Eisai and Purdue Pharma submit an NDA for lemborexant for treating insomnia.
FDA issues a draft guidance on amendments and requests for final approval to tentatively approved ANDAs.
FDA approves a Teva Pharmaceuticals ANDA for the first generic version of Lundbecks Sabril (vigabatrin) 500 mg tablets for treating complex partial se...
FDA issues a revised draft guidance on common issues in drug development for rare diseases.
FDA clears an Immuno Concepts 510(k) for the Histofluor Rodent LKS Tissue Slides for manual and Image Navigator use.
Duane Morris attorneys review key provisions in the FDA final guidance on data integrity and CGMP compliance.
FDA clears an MIM Software Inc. 510(k) for its molecular radiotherapy dosimetry.