Nov 20- The U.S. Food and Drug Administration said it has approved HeartWare International Inc's heart pump that supports blood flow in people with failing hearts who are awaiting a transplant. HeartWare's left ventricular assist device, or LVAD, is designed to be implanted in the chest near the heart and used inside or outside the hospital.
*Republicans give FDA until Nov. 30 to produce documents. "We need these documents to identify any possible weaknesses in FDA's regulatory system that can be immediately corrected administratively or legislatively," said the letter, dated Nov. 16 and addressed to FDA Commissioner Margaret Hamburg by four Republicans, including committee chairman Fred Upton.
Nov 19- GlaxoSmithKline Plc said U.S. health regulators had approved its drug Promacta for the additional use of treating hepatitis C patients with a low platelet count who are unable to undergo standard hepatitis C therapy.
ZURICH, Nov 16- The European Medicines Agency has thrown Novartis' loss-making vaccines business a lifeline by recommending its meningitis B shot for approval, which means the pressure is on to make the product a commercial success.
*Deal will give Allergan prescription, non-prescription products. *Allergan shares rise 1 percent. Nov 16- Allergan Inc, maker of anti-wrinkle drug Botox, on Friday said it would pay $350 million to acquire privately held SkinMedica Inc and its array of topical products to improve the appearance of the skin.
Nov 14- An advisory panel to the U.S. Food and Drug Administration on Wednesday voted unanimously that a GlaxoSmithKline Plc prototype vaccine against bird flu appears to be safe and produces the desired immune-system response against the highly fatal virus.
NEW YORK, Nov 14- European regulators have approved the first in a new class of diabetes medicines that work independently of insulin to control blood sugar, the drug's developers Bristol-Myers Squibb Co and AstraZeneca Plc said on Wednesday.
*Panel questions FDA authority, actions. *FDA chief seeks clear authority over big compounders. WASHINGTON/ NEW YORK, Nov 14- Members of a congressional committee investigating the deadly U.S. meningitis outbreak accused the Food and Drug Administration on Wednesday of failing to prevent the crisis by moving too slowly against a Massachusetts pharmacy.
*Panel chairman said FDA has a lot to answer for. WASHINGTON/ NEW YORK, Nov 14- Members of a congressional committee investigating the deadly U.S. meningitis outbreak on Wednesday accused the Food and Drug Administration of failing to prevent the crisis by moving too slowly against a Massachusetts pharmacy.
*Panel chairman said FDA has a lot to answer for. WASHINGTON, Nov 14- The top official at the U.S. Food and Drug Administration has asked Congress to strengthen federal authority over drug compounders that are not currently subject to the stringent FDA safety and efficacy standards imposed on drug manufacturers.
*Regulators seek stronger FDA role following meningitis outbreak. *Watchdog executives convicted of crimes related to FDA fraud.
WASHINGTON, Nov 13- The U.S. Food and Drug Administration called for congressional action to strengthen the agency's authority over compounding pharmacies, as lawmakers prepared for two days of hearings on a deadly fungal meningitis outbreak linked to compounded steroids.