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...
The 10th Circuit Appeals Court tells a Utah federal court to reconsider portions of a case brought by a couple alleging that their son was born with b...
FDA approves a Cardiovascular Systems PMA supplement for a redesigned saline pump used as part of its Diamondback 360 Orbital Atherectomy Systems.
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.