FDA grants Altor BioScience a fast track designation for its investigational interleukin-15 agonist complex, ALT-803, in combination with bacillus Cal...
The Biosimilars Forum urges FDA to be more flexible with its approach in determining a proposed biosimilar products interchangeability with an innovat...
Wockhardt says expenses to correct issues raised by FDA at several of its facilities adversely affected company profitability in the first quarter.
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...