AcuFocus is pleased to announce they received approval from the Korean Food and Drug Administration (KFDA) for the KAMRA inlay, making this revolutionary treatment option for near vision loss available to the Korean population.

(Johns Hopkins Medical Institutions) The Institute of Medicine has released a report recommending that the Food and Drug Administration take proactive steps to continue monitoring drugs' safety after initial approval and throughout their time on the market, as well as form a new body to advise on the ethical challenges ...

(Cedars-Sinai Medical Center) Cedars-Sinai Medical Center has become the first West Coast site -- and one of only three nationwide -- to implant a device that stimulates the respiratory muscle in the chest and draws air into the lungs of patients suffering from amyotrophic lateral sclerosis under recently approved Food ...

The U.S. Food and Drug Administration today approved Stendra (avanafil), a new drug to treat erectile dysfunction.

Cameron Health, Inc., a pioneer in the development, manufacture and distribution of next generation implantable cardioverter defibrillators (ICDs), announced today that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel voted 7-1 that sufficient data exists demonstrating the efficacy and safety of the S-ICD System for the treatment ...

The U.S. Food and Drug Administration today approved Votrient (pazopanib) to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy. Soft tissue sarcoma is a cancer that begins in the muscle, fat, fibrous tissue, and other tissues.

The U.S. Food and Drug Administration today approved Afinitor (everolimus), the first drug approved specifically to treat non-cancerous kidney tumors (renal angiomyolipomas) not requiring immediate surgery in patients with tuberous sclerosis complex.

The United States Food and Drugs Administraton (FDA) has proposed that food companies that want to use tiny engineered particles called nanoparticles in their packaging may have to provide extra testing data to show the products are safe.

A more robust postmarket drug safety program has helped improve the FDA's (Food and Drug Administration) oversight of medications after they have been approved, says a report issued by CDER (Center for Drug Evaluation and Research). CDER is part of the FDA. The authors explained how new scientific tools improved ...

Synthon has announced that its subsidiary Synthon Pharmaceuticals, Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application for tadalafil tablets, 20 mg on April 13, 2012. Synthon's product is a generic and bioequivalent version of Eli Lilly & Co and ...

St. Jude Medical, Inc., a global medical device company, today announced CE Mark Approval of the Ellipse implantable cardioverter defibrillator (ICD). Designed with feedback from more than 200 physicians from around the world, the Ellipse ICD provides the benefits of advanced features and power in the industry's smallest high-energy ICD.

Biovest International, Inc., a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc., today announced that Biovest is seeking marketing approval in Canada for BiovaxID, its personalized cancer vaccine for the treatment of follicular non-Hodgkin's lymphoma, an incurable cancer of the immune system.