FDA says Medtronics recall of a HeartWare driveline splice kit due to a design defect that could lead to an interrupted electrical connection to a ven...
FDA grants special regulatory designations to three additional Sangamo Therapeutics products.
Apotex asks FDA to set specific requirements for biosimilar applicants referencing Amgens Neulasta.
FDA clears an Interscope 510(k) for the EndoRotor System for use in gastroenterology and colorectal surgery.
FDA gives Soligenix the green light to advance a pivotal Phase 3 clinical trial evaluating SGX942 (dusquetide) for treating oral mucositis in head and...
FDA approves an investigator-initiated IND to begin a Phase 1 trial involving ZioPharm Oncologys CD33-specific CAR-T therapy for relapsed or refractor...
Seven patient advocacy groups issue principles they want to see followed in any changes to the compassionate use process.
FDA releases an FDA-483 with six observations from an agency inspection at Indias Aurobindo Pharma.