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FDA Approvals - euro adhoc: Intercell AG / other / Positive results for


euro adhoc: Intercell AG / other / Positive results for Intercell s Japanese Encephalitis virus vaccine in pivotal (vwd.de)
-------------------------------------------------------------------------------- Disclosure announcement transmitted by euro adhoc. The issuer is responsible for the content of this announcement.

Chembio Receives FDA Approval for Its Rapid HIV Tests (Business Wire via Yahoo! Finance)
MEDFORD, N.Y.----May 30, 2006--Chembio Diagnostics, Inc. has received approval from the U.S. Food and Drug Administration for its SURE CHECK HIV 1/2 and HIV 1/2 STAT-PAK rapid test Pre-Market Applications .

Smith & Nephew Announces FDA Approval of Burn Indication for VERSAJET(TM) in the USA (PR Newswire via Yahoo! Finance)
Smith & Nephew's Advanced Wound Management division, announced today that the U.S. Food and Drug Administration approved a label amendment for its advanced surgical wound management product, VERSAJET.

FDA Statement on European Aspartame Study The U.S. Food and


FDA Statement on European Aspartame Study
The U.S. Food and Drug Administration is reviewing data from a long-term carcinogenicity study of aspartame conducted by the European Ramazzini Foundation (ERF) in response to a European Food Safety Authority (EFSA) press release on its review of the study.

Novelos Therapeutics Finalizes SPA with FDA for Phase 3 Trial


Novelos Therapeutics Finalizes SPA with FDA for Phase 3 Trial in Lung Cancer (Business Wire via Yahoo! Finance)
NEWTON, Mass.----May 30, 2006--Novelos Therapeutics, Inc. , a biotechnology company focused on the development of therapeutics to treat cancer and hepatitis, today announced that it has finalized a Special Protocol Assessment with the Food and Drug Administration for a single pivotal Phase 3 trial in advanced non-small cell lung cancer for its lead product NOV-002 in combination with first-line

WRAP 100 Receives US FDA Approval (PackagingNetwork)
Stanelco is pleased to announce that FDA compliance for its new material, Wrap 100, has now been confirmed by Pira International (the UK approved testing house for the FDA) for food contact approval

Stanelco plc (``Stanelco'' or ``the Company'') - WRAP 100 Receives US FDA Approval (Business Wire via Yahoo! Finance)
ORLANDO, Fla.----May 25, 2006--Stanelco is pleased to announce that FDA compliance for its new material, WRAP 100, made principally from sustainable resources, has now been confirmed by Pira International for food contact approval.

FDA Approvals - Sonus Pharmaceuticals to Present at Bear Stearns Biotech Boston Confab


Sonus Pharmaceuticals to Present at Bear Stearns Biotech Boston Confab on May 31 (Business Wire via Yahoo! Finance)
BOTHELL, Wash.----May 30, 2006--Sonus Pharmaceuticals, Inc. today announced that Michael A. Martino, President and CEO, will present at the Bear Stearns Biotech Boston Confab on Wednesday, May 31, at 12:00 P.M.

AFP Imaging Negotiating to Acquire Leading Edge Imaging Technology (Business Wire via Yahoo! Finance)
ELMSFORD, N.Y.----May 30, 2006--AFP Imaging Corporation AFP Imaging Corporation announced that it has entered into negotiations to acquire Quantitative Radiology, srl. of Verona, Italy.

FDA Approvals - India's Cipla, Sun get tentative FDA approvals (Reuters via Yahoo!


India's Cipla, Sun get tentative FDA approvals (Reuters via Yahoo! Asia News)
MUMBAI, May 23 (Reuters) - Indian drug maker Cipla Ltd. has received tentative approval from the U.S. Food and Drug Administration for generic AIDS drug nevirapine in the tablet form, according to an FDA statement.

Teva to launch generic Zocor in June (Globes Online)
Leader: Revenue from the product will be $250 million in six months, and Teva will continue to fight the FDA over exclusivity.

Birmingham Hip Resurfacing (BHR) System The Birmingham Hip Resurfacing (BHR)


Birmingham Hip Resurfacing (BHR) System
The Birmingham Hip Resurfacing (BHR) System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The BHR is called a resurfacing prosthesis because only the surface of the femoral head (ball) is.. (Approved: 5/9/2006)

Rajbhog Foods Inc Issues Allergy Alert on Undeclared Milk Allergens


Rajbhog Foods Inc Issues Allergy Alert on Undeclared Milk Allergens in Exotic Sweets Brand Kaju Katli
The recalled "Exotic Sweets Brand Kaju Katli" sweets were distributed by Exotic Foods Inc. throughout NY, NJ and PA in retail stores. The product comes in a 14 ounce clear plastic package coded 79.06.

Jumbo Foods Recalls Smoked Turkey on Sourdough Triple Decker Sandwich Because of Possible Health Risk
The product was packaged in clear plastic with a label bearing its name, Smoked Turkey on Sourdough, 6.6oz, coded 051906 16D.

FDA Approves Remicade for Children with Crohn s Disease Remicade is


FDA Approves Remicade for Children with Crohn s Disease
Remicade is a genetically engineered monoclonal antibody, which reduces inflammation (swelling/redness) by blocking the action of tumor necrosis factor-alpha (TNF- ), that was initially approved in 1998 to treat Crohn's disease in adults.

FDA Approvals - ABIOMED Receives FDA Approval to Commence IMPELLA 2.5 U.S. Trial;


ABIOMED Receives FDA Approval to Commence IMPELLA 2.5 U.S. Trial; Indication for Use is Support During High-Risk (FinanzNachrichten)
ABIOMED, Inc. (NASDAQ: ABMD) today announced that the U.S. Food and Drug Administration (FDA) granted approval for the Company to commence its pilot clinical trial immediately in the United States for the IMPELLA(R) 2.5 minimally invasive ventricular assist device (VAD). The approval is conditioned upon the Company's submission of additional information to the FDA over the next 45 days.

Teva to launch generic Zocor in June (Globes Online)
Leader: Revenue from the product will be $250 million in six months, and Teva will continue to fight the FDA over exclusivity.

Pivotal Phase III Studies Presented During Digestive Disease Week (DDW)


Pivotal Phase III Studies Presented During Digestive Disease Week (DDW) Show MMX Mesalamine (Mesavance(TM)) Induced (Medical News Today)
Combined results of two pivotalphase III clinical studies (301 and 302) of a novel formulation ofMulti-Matrix System(TM) (MMX) mesalamine, a medication currently underreview by the FDA, Canadian, and EU regulatory agencies, were presentedtoday during DDW at the Los Angeles Convention Center. [click link for full article]

MedSpa Solutions Awarded Contract by Irvine Plastic Surgeon (SYS-CON Media)
MedSpa Solutions Inc., a wholly owned subsidiaryof Winsted Holdings Inc. (OTCBB: WNSH), today announced that it was awardeda comprehensive consultancy contract by a physician in Irvine, California.This Contract covers Business Development, Core Site Design, VendorRelationships, Licensing & Compliance Assistance and Custom MarketingDevelopment.

Corautus Genetics warned of delisting (Atlanta Business Chronicle)
Corautus Genetics Inc. faces delisting from NASDAQ if it cannot get its trading price back above $1 a share for a minimum of 10 business days.

FDA Approvals - Lupin Announces Final FDA Approval of Cefdinir Capsules (PR Newswire


Lupin Announces Final FDA Approval of Cefdinir Capsules (PR Newswire via Yahoo! Finance)
Lupin Pharmaceuticals, Inc. announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Cefdinir Capsules, 300 mg.

ABIOMED Receives FDA Approval to Commence IMPELLA 2.5 U.S. Trial; Indication for Use is Support During High-Risk (FinanzNachrichten)
ABIOMED, Inc. (NASDAQ: ABMD) today announced that the U.S. Food and Drug Administration (FDA) granted approval for the Company to commence its pilot clinical trial immediately in the United States for the IMPELLA(R) 2.5 minimally invasive ventricular assist device (VAD). The approval is conditioned upon the Company's submission of additional information to the FDA over the next 45 days.

US FDA approves Lupin's Cefdinir (PharmaBiz)
The US FDA has approved Lupin's Abbreviated New Drug Application (ANDA) for Cefdinir capsules 300mg.

FDA Approvals - US FDA approves Lupin's Cefdinir (PharmaBiz) The US FDA has


US FDA approves Lupin's Cefdinir (PharmaBiz)
The US FDA has approved Lupin's Abbreviated New Drug Application (ANDA) for Cefdinir capsules 300mg.

FDA Approves Expanded Label for IV Antibiotic CUBICIN(R) to Add Bloodstream Infections Including Right-Sided Infective (Business Wire via Yahoo! Finance)
LEXINGTON, Mass.----May 25, 2006--Cubist Pharmaceuticals, Inc. today announced that the U.S. Food & Drug Administration has approved the supplemental new drug application for CUBICIN as once-a-day therapy at 6 mg/kg for the treatment of Staphylococcus aureus bloodstream infections including right-sided endocarditis caused by MSSA and MRSA .

ABIOMED Receives FDA Approval to Commence IMPELLA 2.5 U.S. Trial (Business Wire via Yahoo! Finance)
DANVERS, Mass.----May 25, 2006--ABIOMED, Inc. today announced that the U.S. Food and Drug Administration granted approval for the Company to commence its pilot clinical trial immediately in the United States for the IMPELLA 2.5 minimally invasive ventricular assist device .

Bausch and Lomb Global Recall of ReNu with MoistureLoc Contact


Bausch and Lomb Global Recall of ReNu with MoistureLoc Contact Lens Cleaning Solution
On Thursday, May 11, 2006 a team from Bausch and Lomb met with Food and Drug Administration (FDA) officials to share information resulting from the company's internal investigation into cases of Fusarium keratitis associated with ReNu with MoistureLoc.

Stelex University Provides Computer Systems Validation and Quality Auditor Training


Stelex University Provides Computer Systems Validation and Quality Auditor Training to the FDA's National Center for (PR Newswire via Yahoo! Finance)
Stelex University , the professional education and technical training arm of Stelex - The Validation Group, Inc. , presented a training session entitled "Computer Systems Validation in a Good Laboratory Practice Environment" for the FDA's NCTR group located in Jefferson, Arkansas.

MedSpa Solutions Awarded Contract by Irvine Plastic Surgeon (SYS-CON Media)
MedSpa Solutions Inc., a wholly owned subsidiaryof Winsted Holdings Inc. (OTCBB: WNSH), today announced that it was awardeda comprehensive consultancy contract by a physician in Irvine, California.This Contract covers Business Development, Core Site Design, VendorRelationships, Licensing & Compliance Assistance and Custom MarketingDevelopment.

FDA Approvals - Cipla, Sun get tentative FDA approvals (NDTV Profit) MUMBAI (Reuters)


Cipla, Sun get tentative FDA approvals (NDTV Profit)
MUMBAI (Reuters) - Cipla Ltd. has received tentative approval from the U.S. Food and Drug Administration for generic AIDS drug nevirapine in the tablet form, according to an FDA statement.

FDA Approves Duramed's SEASONIQUE(TM) Extended-Cycle Oral Contraceptive Company's Second Proprietary Extended-Cycle OC (PR Newswire via Yahoo! Finance)
Barr Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved its Duramed Pharmaceuticals, Inc.'s New Drug Application for SEASONIQUE extended-cycle oral contraceptive for the prevention of pregnancy.

VISTAKON (senofilcon A) Contact Lens VISTAKON (senofilcon A) is a


VISTAKON (senofilcon A) Contact Lens
VISTAKON (senofilcon A) is a soft contact lens made of approximately 38% water and 62% senofilcon A (a silicone-containing hydrogel). It is available in spherical, toric, multifocal, and multifocal-toric designs. (Approved: 12/20/2005)

Jai Bhavani Fruits and Vegetables Inc. Issues Allergy Alert on


Jai Bhavani Fruits and Vegetables Inc. Issues Allergy Alert on Undeclared Sulfites in Bhavani Golden Raisins
The recalled BHAVANI GOLDEN RAISINS packed in 7 oz. uncoded plastic bags, were sold to Akota Meat Market located in New York City.

Bausch and Lomb Global Recall of ReNu with MoistureLoc Contact Lens Cleaning Solution
Bausch and Lomb has decided to permanently remove the ReNu with MoistureLoc product worldwide. FDA supports this decision.

IVAX Pharmaceuticals Issues a Nationwide Recall of Goldline Brand Extra Strength Genapap and Extra Strength Genebs
IVAX Pharmaceuticals, Inc. is initiating a recall of Goldline brand Extra Strength Genapap 500mg (Acetaminophen) Caplets and Tablets and Extra Strength Genebs 500mg (Acetaminophen) Caplets and Tablets. The product lots are being recalled due to a labeling error.

FDA Approvals - J&J wins FDA OK for skin-patch drug (The Star-Ledger) Johnson


J&J wins FDA OK for skin-patch drug (The Star-Ledger)
Johnson & Johnson has won regulatory clearance to begin selling a skin patch that allows post-surgery patients to give themselves a painkiller without a needle stick.

Amarillo Biosciences Announces Phase II Study of Orally Administered Interferon Alpha in the Treatment of Oral Warts in (SYS-CON Media)
Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR)today announced submission to the FDA of a protocol for a Phase II study totest low-dose interferon alpha lozenges administered orally to humanimmunodeficiency virus (HIV)-positive subjects with oral warts. Virallesions of the mouth in patients infected with HIV are common and may beindicative of disease progression. One of the causes of oral lesions

FDA Clearance Under A Special Protocol Assessment To Initiate CoFactor Phase III Clinical Trial (Medical News Today)
ADVENTRX Pharmaceuticals,Inc. (Amex: ANX) announced today that it reached an agreement under aspecial protocol assessment (SPA) with the US Food and Drug Administration(FDA) on the design of the Company's CoFactor(R) Phase III clinical trialprotocol. The Company also announced it remains on track to initiate thePhase III clinical trial in Q2 2006. [click link for full article]

FDA Finalizes Health Claim Associating Consumption of Barley Products with


FDA Finalizes Health Claim Associating Consumption of Barley Products with Reduction of Risk of Coronary Heart Disease
Today the Food and Drug Administration announced that it has finalized a rule that allows foods containing barley to claim that they reduce the risk of coronary heart disease.

Dyax Announces the Appointment of Peggy Berry as Senior Vice


Dyax Announces the Appointment of Peggy Berry as Senior Vice President of Quality and Regulatory Affairs (Business Wire via Yahoo! Finance)
CAMBRIDGE, Mass.----May 24, 2006--Dyax Corp. today announced that Peggy Berry has joined the Company as Senior Vice President, Quality and Regulatory Affairs. Ms. Berry joins Dyax's senior management team where she will be responsible for overseeing the Company's quality and regulatory departments.

Stelex University Provides Computer Systems Validation and Quality Auditor Training to the FDA's National Center for (PR Newswire via Yahoo! Finance)
Stelex University , the professional education and technical training arm of Stelex - The Validation Group, Inc. , presented a training session entitled "Computer Systems Validation in a Good Laboratory Practice Environment" for the FDA's NCTR group located in Jefferson, Arkansas.

FDA Grants Fast Track Designation to Nektar's Amphotericin B Inhalation Powder (ABIP) for Prevention of Pulmonary (Business Wire via Yahoo! Finance)
SAN CARLOS, Calif.----May 22, 2006--Nektar Therapeutics announced today the U.S. Food and Drug Administration has granted Fast Track designation to Amphotericin B Inhalation Powder for prevention of pulmonary fungal infections in patients at risk for aspergillosis due to immunosuppressive therapy, including those receiving organ or stem cell transplants, or treated with chemotherapy or radiation
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