Johnson & Johnson Pharmaceutical Research & Development, LLC, has received a Complete Response letter regarding its New Drug Application for ceftobiprole medocaril to treat complicated skin and skin structure infections, including diabetic foot infections.
The New Drug Application (NDA) by Watson Pharmaceuticals, Inc., for a six-month formulation of Trelstar (triptorelin pamoate) has been accepted for filing.
PLC Medical Systems, Inc., of Franklin, Mass., has received full approval for a U.S. pivotal trial to study the effectiveness of its RenalGuard System and associated therapy in the prevention of contrast-induced nephropathy (CIN).
FlowMedica, Inc., of Fremont, Calif., announced that it has received clearance for a new labeling indication for its Benephit Infusion Systems, which can now facilitate targeted renal therapy (TRT) in patients who have demonstrated symptoms of or are at risk of developing acute kidney injury (AKI).
Toviaz (fesoterodine fumarate), manufactured by Schwarz Pharma of Zwickau, Germany, and distributed by Pfizer, has been approved to help patients suffering from overactive bladder (OAB).
The FDA has issued an alert to health-care professionals and the public after receiving reports of complications from the use of surgical mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Sanofi-aventis has received approval for Apidra (insulin glulisine [rDNA origin] injection) to improve glycemic control in children aged four years and older with diabetes mellitus.
Vaprisol (conivaptan hydrochloride injection) Premixed in 5% Dextrose, a new formulation of Vaprisol developed by Astellas Pharma US, Inc., has been approved for the treatment of both euvolemic and hypervolemic hyponatremia in hospitalized patients.
An FDA analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), the neurodegenerative disorder commonly called “Lou Gehrig’s disease.”
Oxford BioMedica, a leading gene therapy company in the United Kingdom, has announced an agreement with the FDA concerning a series of amendments to its phase 3 study of TroVax, a novel therapeutic vaccine for renal cancer.
