Gordon Gund, Gund Investment Corp. chairman & CEO, who lost his sight 40 years ago, discusses the promising work being done to find a cure for blindness.» Read More
The FDA said it imposed the new requirements after deciding that tanning beds and booths that use ultraviolet lamps pose a moderate risk of causing skin cancer, up from the previous classification of low-risk.
May 28- Acura Pharmaceuticals Inc's shares fell as much as 21 percent to a life low on Wednesday, a day after the U.S. health regulator said data on its experimental painkiller was insufficient to support its claim that the drug could not be abused by snorting.
*Exec says FDA issued observations on its US unit's production process. The United States is Wockhardt's biggest market and the FDA has already banned the import of generic drugs from its two plants in India, citing quality lapses in the manufacturing process.
Two companies issued voluntary recalls of hummus dips and walnuts sold at major retailers after listeria was detected in samplings of the products.
May 20- U.S. health regulators on Tuesday approved a drug from Japan's Takeda Pharmaceutical Co Ltd to treat the chronic debilitating inflammatory diseases ulcerative colitis and Crohn's disease.
The FDA banned imports from Sun Pharma's Karkhadi plant in Gujarat state in March, but the reason for the ban was not clear at that time. In the warning letter dated May 7 and posted on the FDA website on Tuesday, the regulator said Sun Pharma failed to ensure laboratory records had complete data and that manufacturing staff had inadequate training and experience.
May 19- U.S. regulators have approved a new non-caloric sweetener from Japan's Ajinomoto Co that can be used as a substitute for sugar or high fructose corn syrup in foods and beverages. FDA said the product can be used as a tabletop sweetener or in baked goods, non-alcoholic beverages, frozen desserts, jams and jellies, chewing gum and other foods.
May 15- Mylan Inc said a U.S. district court dismissed a case by Israeli drugmaker Teva Pharmaceutical Industries Ltd intended to block the U.S. health regulator from approving generic versions of Teva's multiple sclerosis drug Copaxone. U.S. generic drugmaker Mylan said it had intervened in the lawsuit in support of the U.S. Food and Drug Administration.
Unlike prescription drugs the FDA does not inspect vitamins before they hit the market. Neil Thanedar, LabDoor CEO, provides independent product safety research and grading to help consumers learn what's really inside their vitamins.
WASHINGTON, May 9- The U.S. Food and Drug Administration has approved a robotic arm for amputees that is named for the "Star Wars" character Luke Skywalker and can perform multiple, simultaneous movements, a huge advance over the metal hook currently in use.
WASHINGTON, May 9- The U.S. Food and Drug Administration has approved the use of a robotic arm for amputees that is named for the "Star Wars" character Luke Skywalker and can perform multiple, simultaneous movements.
Lawmakers in four states are considering changing the rules to allow terminally ill people access to experimental drugs before they have FDA approval. Kenneth Goodman, University of Miami, thinks this would be a bad bet for patients. Miles Nadal, MDC Partners Chairman & CEO, weighs in.
Robert Temple, the agency's deputy director for clinical science, said in an FDA "consumer update" that people should use daily aspirin therapy only after talking to a healthcare professional who can assess the benefits and risks.
The FDA said that people should use daily aspirin therapy only after assessing the benefits and risks.
May 2- Acorda Therapeutics Inc said the U.S. Food and Drug Administration rejected its nasal form of the current standard therapy for epilepsy patients who experience repetitive seizures.
May 2- Acorda Therapeutics Inc said the U.S. Food and Drug Administration rejected its nasal spray to treat epilepsy patients who experience repetitive seizures. The drugmaker did not disclose the reason for the rejection, but said it planned to resubmit the application for the treatment.
April 28- Actavis Plc said on Monday it has sued the U.S. Food and Drug Administration, challenging its decision to award exclusive rights to Teva Pharmaceutical Industries Ltd to sell a generic version of Pfizer Inc's blockbuster painkiller Celebrex. A similar lawsuit was announced Friday by Mylan Inc over generic drug marketing exclusivity for Celebrex.
April 28- Actavis Plc on Monday said it has sued the U.S. Food and Drug Administration, challenging its decision to award exclusive rights to Teva Pharmaceutical Industries Ltd to sell a generic version of Pfizer Inc's blockbuster painkiller Celebrex.
CNBC's Seema Mody, Bob Pisani and Tyler Mathisen looks at today's "Power Lunch" stories, including news the FDA is proposing the first regulations on electronic cigarettes.
WASHINGTON, April 24- The U.S. Food and Drug Administration proposed rules on Thursday that would ban the sale of e-cigarettes to anyone under 18, but would not restrict flavored products, online sales or advertising, which public health advocates say attract children.