Pharmacy News EU

Catheter Connections, Inc., a manufacturer of innovative vascular access and infection control products, announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its DualCap? product. DualCap is the only device that nests two disinfecting caps together – for both IV access points, the needleless injection site (NIS) [...]

Pharmaceutical company Bionovo Inc (Nasdaq:BNVI) announced today the receipt of final guidance from the European Medicines Agency (EMA) in order to advance Menerba, the company’s lead drug candidate for menopausal symptoms, to Phase 3 clinical trials in Europe.This guidance reportedly defines the clinical and regulatory pathway to a European marketing authorisation for Menerba.The company plans [...]

Health care company Abbott (NYSE:ABT) stated on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for two new dosage strengths of SIMCOR (niacin extended-release / simvastatin), a cholesterol medication.The company claimed the new SIMCOR dosage strengths combine 40 mg of simvastatin, which is the most commonly prescribed dose of simvastatin, [...]

EMERYVILLE, Calif., July 29 /PRNewswire-FirstCall/ Bionovo, Inc. (Nasdaq: BNVI) announced today that it has received final guidance from the European Medicines Agency (EMA) in order to advance Menerba, the company's lead drug candidate for menopausal symptoms, to Phase 3 clinical trials in Europe. The guidance defines the clinical and regulatory pathway to a European [...]

IRVINE, Calif., July 29 /PRNewswire-FirstCall/ Endologix, Inc. (Nasdaq: ELGX), developer of minimally invasive treatments for aortic disorders, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its new PowerFit? Aortic Extensions. The PowerFit extensions are designed to provide physicians with enhanced visibility under fluoroscopy to facilitate precise device placement [...]

A new free, white paper that guides medical device manufacturers in the complicated process of applying new U.S. Food and Drug Administration (FDA) regulations to combination products embedded with pharmaceutical or biologic components is now available from Microtest Laboratories products are a large and growing segment of the medical device market, with some analysts estimating [...]

MARLBOROUGH, Mass.(BUSINESS WIRE) Advanced Cell Technology, Inc. (ACT?; OTCBB:ACTC) announced today that it has submitted documentation and a complete response to substantively address the issues raised by the US Food and Drug Administration (FDA) in [...]

TIME: 8 a.m.EVENT: Health and Human Services Department (HHS); Food and Drug Administration (FDA) (F.R. Page 35496) holds a meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss Revatio (sildenafil) for the treatment of pediatric pulmonary arterial hypertension (PAH) and whether to amend the clinical trials section of the written request, issued by [...]

ABBOTT PARK, Ill., July 28 /PRNewswire-FirstCall/ Abbott (NYSE: ABT) today received U.S. Food and Drug Administration (FDA) approval for two new dosage strengths of SIMCOR, a cholesterol medication. The new SIMCOR dosage strengths combine 40 mg of simvastatin the most commonly prescribed dose of simvastatin with either 500 mg or 1,000 mg [...]

WASHINGTON, July 28 /PRNewswire-USNewswire/ Today FRC Action joined 19 pro-life groups in a letter sent to Food and Drug Administration (FDA) Commissioner Margaret Hamburg requesting that Ella, a drug under consideration for FDA approval that can cause abortions but is misleadingly labeled as an "emergency contraceptive," not be approved. Tom McClusky, FRC Action's Senior [...]