FDA Approvals - FDA Grants Fast Track Designation For Boehringer Ingelheim's BIBW 2992
FDA Grants Fast Track Designation For Boehringer Ingelheim's BIBW 2992 For The Treatment Of Late Stage Non Small Cell ... (Medical News Today)
Boehringer Ingelheim's investigational cancer treatment BIBW 2992 has recently received a Fast Track Designation status by the FDA. Under this designation, Boehringer Ingelheim will conduct a pivotal trial programme studying BIBW 2992 in a non-small cell lung cancer (NSCLC) patient group where prior treatment with reversible EGFR inhibitors has failed.
St Jude gets FDA and CE Mark approvals for neurostimulator longevity claim (Pharmaceutical Business Review)
St Jude Medical has received FDA and European CE Mark approvals of a 10-year battery longevity claim for the Eon neurostimulator, a rechargeable device used to treat chronic pain.