Journals By Industry - FDA Review

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...

Both pivotal Phase III studies are fully recruited, and all patients have been treated, reached the primary endpoint and are in long-term follow-up. The study met all primary, secondary and tertiary efficacy endpoints....

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...

GS-7340 is a novel prodrug of tenofovir, the active agent in Viread, or tenofovir disoproxil fumarate. In previous studies, GS-7340 has demonstrated the ability to provide greater antiviral efficacy at a dose that...

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...

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,...

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...

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...

BOULDER, Colo. -- On November 8, 2011, Covidien initiated a voluntary recall of certain lots of its BIS[TM] Bilateral Sensors, due to a modification which inadvertently reversed the reference and left eye electrode....

MALVERN, Pa. -- Ceptaris Therapeutics, Inc., a privately held specialty pharmaceutical company, announced today that the European Medicines Agency (EMA) has granted Orphan Drug Designation to Ceptaris' investigational drug, chlormethine gel (also known...

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,...

- Additional End-of-Phase 2 Meeting Not Required- -Company to Submit for Special Protocol Assessment- KNOXVILLE, Tenn. -- Provectus Pharmaceuticals, Inc. (OTCBB: PVCT, http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, has received guidance...

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...

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...

RENO, Nev. -- SonoCine, Inc., the leading innovator of automated whole breast ultrasound (AWBU) screening systems for early detection of breast cancer, announced today that it has been granted a Class 2 Medical...

Research to Provide Foundation for Use of Biocompatible Hydrogel Therapies Beyond Spinal Cord Injury Treatment CAMBRIDGE, Mass. & DANVILLE, Pa. -- InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for...

EWING, N.J. -- Antares Pharma, Inc. (NYSE Amex: AIS) today announced that it has licensed exclusively its Oxybutynin Gel 3% to Daewoong Pharmaceuticals Co. Ltd.,for marketing in South Korea. Antares will receive undisclosed...