Journals By Industry - Drug & Medical Devices Approval

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...

For overweight consumers looking to lose weight fast, the use of lap band surgery as a quick and easy way to a new life can be tempting. But in some cases, it's deadly....

An independent watchdog group has asked the Food and Drug Administration to disregard a safety panel's recommendation to keep the popular birth control drugs Yaz and Yasmin on the market, citing evidence that...

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)...

NovaDel Pharma, Inc., a specialty pharmaceutical company, has terminated its license agreements with Talon Therapeutics, Inc. (formerly Hana Biosciences, Inc. ) and Par Pharmaceutical Companies, Inc., for Zensana. Talon is a biopharmaceutical company,...

After a long delay, Roche Diagnostics Corp. this month won approval from the U.S. Food and Drug Administration for its Accu-Chek Nano SmartView blood glucose monitoring system. The approval comes more than two...

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...

The head of the Food and Drug Administration's medical device unit stopped in San Diego last week for a series of one-on-one meetings with some of the area's largest device makers, including ResMed...

PRINCETON, N.J. & WILMINGTON, Del. -- Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the...

-- 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...

--Middle Tennessee's only certified Destination Therapy program offers renewed hope and results for advanced heart failure patients-- NASHVILLE, Tenn. -- Saint Thomas Hospital, a member of Saint Thomas Health and a national leader...

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...