Journals By Industry - FDA Approvals

KALYDECO is approved for people with CF ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. KALYDECO was granted...

In SHARP, VYTORIN 10/20 mg lowered LDL cholesterol in patients with moderate to severe chronic kidney disease, or CKD, and major vascular events were reduced in the treatment group compared to placebo. The...

The company has also announced the assignment of US co-promotion rights to AQUORAL, an FDA-cleared, prescription-only spray for the treatment of Xerostomia, or the medical term for dry mouth due to a lack...

Keppra was previously approved in the US as adjunctive therapy for partial onset seizures in adults and children four years of age and older with epilepsy. The approval was based on data from...

Results from the trial, expected in 2014, could potentially impact atrial fibrillation treatment guidelines by providing further clinical evidence regarding the benefits of the Arctic Front system in treating a largely underserved patient...

The Medicines Company (MDCO) has settled the lawsuits filed in the US district court for the district of Delaware relating to the Abbreviated New Drug Application (ANDA) filed by APP Pharmaceuticals, LLC (APP)...

Acne is the most common skin disorder in the United States, affecting up to 50 million people, according to the American Academy of Dermatology. It's so widespread that by their mid-teens, more than...

-- Test Associated with Changes in Treatment Management in 65% of Patients with Difficult-to-Diagnose Cancers -- REDWOOD CITY, Calif. -- Pathwork Diagnostics, Inc., a pioneer in creating genomics-based diagnostics in oncology utilizing their...

Conformable GORE[R] TAG[R] Thoracic Endoprosthesis Designed for Endovascular Repair of the Descending Thoracic Aorta Provides Conformability without Compromise FLAGSTAFF, Ariz. -- W. L. Gore & Associates, Inc. (Gore) announced that the US Food...

DUBLIN -- Research and Markets (http://www.researchandmarkets.com/research/1864b5/key_companies_neu) has announced the addition of the "Key Companies: Neuropathic Pain - In-house to in-license as Big Pharma cuts down on early-stage research" report to their offering. Pfizer...

BALERNA, Switzerland -- APR Applied Pharma Research s.a. ("APR"), Labtec GmbH ("Labtec") and Norgine BV ("Norgine") announce the signature of an exclusive licensing agreement under which Norgine will market and distribute Setofilm[TM] Ondansetron...

KIRKLAND, Wash. -- Vioguard[TM] LLC (www.vioguard.com) today announced it has signed a sales and distribution agreement with HP to market and sell the Vioguard self-sanitizing computer keyboard. The product was recently cleared by...

BRIDGEWATER, N.J. -- NovaDel Pharma Inc. (OTCBB: NVDL), a specialty pharmaceutical company that develops oral spray formulations of marketed pharmaceutical products, today announced that, as previously disclosed, it is continuing to explore various...

AMITYVILLE, N.Y. -- Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK), a specialty pharmaceuticals company, announced today that it has acquired marketing and distribution rights to a topical wound gel product from Glycobiosciences , Inc. The...

Despite Downward Pressure on Average Selling Prices, Procedural Growth Will Drive Revenues, According to Millennium Research Group TORONTO -- According to Millennium Research Group (MRG), the global authority on medical technology market intelligence,...

BURLINGTON, N.C. -- Laboratory Corporation of America([R])Holdings (LabCorp([R])) (NYSE: LH) announced today the nationwide availability of a new FDA cleared risk stratification tool (ROMA([R]), Risk of Ovarian Malignancy Algorithm) that combines the results...

CAMBRIDGE, Mass. -- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the European Medicines Agency (EMA) has approved its manufacturing plant in Framingham, Mass., for the production of Fabrazyme([R])...

NEW YORK -- Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer, today announced that reported earnings per share were $1.04 in the third quarter of fiscal 2012. Reported earnings per...

SALT LAKE CITY -- BSD Medical Corporation (NASDAQ:BSDM) (Company or BSD) (www.bsdmedical.com), a leading provider of medical systems that utilize heat therapy to treat cancer, today announced the purchase, installation and acceptance of...