pSivida (NSDQ:PSDV) started recruiting patients in a Phase III U.S. trial for its eyelash-sized drug/device combination, an implant designed to treat ocular swelling that can lead to blindness.
Ocular Therapeutix closes enrollment in Phase II study of tear duct plug
Ocular Therapeutix wrapped up patient enrollment for a Phase II trial evaluating the company’s OTX-DP tear duct plug, the company announced this week.
pSivida wins approval for Iluvien in Germany
Theravance/Glaxo's Breo Ellipta wins FDA go-ahead
pSivida's new Iluvien approval attempt focuses on safety
pSivida takes another stab at FDA approval for Iluvien
FDA issues final rule on device, drug, biologic combinations
Federal regulators this week published a final rule governing Current Good Manufacturing Practice requirements for products made up of a combination of devices, drugs and/or biologics, categories which are usually regulated by separate FDA divisions.
The long-awaited rule is meant to provide clarification on CGMP requirements for products that include any fusion of the medical products either as packaged together or as a "single-entity" combination.
FDA clears Ikaria's upgraded neonate drug delivery system
Hampton, N.J.-based healthcare company Ikaria won FDA clearances for an upgraded software package and 3 non-invasive respiratory care devices for use with its Inomax DSIR drug delivery system.
The Inomax DS and DSIR deliver the company’s proprietary Inomax vasodilator solution, which the company calls the only FDA-approved drug for treatment of infant hypoxic respiratory failure, associated with pulmonary hypertension.
Delcath's cancer-treating system lands U.S., Australian regulatory wins
Medical device company Delcath Systems (NSDQ:DCTH) is on a roll, notching a couple new regulatory milestones this month for its organ-isolating ChemoSat chemotherapy treatment systems.
Cancer: Delcath lands expanded CE Mark for organ-isolating chemo treatment
Delcath Systems (NSDQ:DCTH) won expanded CE Mark approval in the European Union for its ChemoSat organ-isolating cancer treatment system, landing indication for a new drug used to target liver tumors.
