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FDA in Biological Technology

Cell Therapeutics Second Quarter Net Loss Decreases 54%; Pixantrone NDA Submitted to the FDA for Approval

SEATTLE, Aug. 6 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today reported recent achievements and financial results for the second quarter and six months ended June 30, 2009. "The second quarter of 2009 was a transforming quarter for the Co...

Exciton Technologies receives FDA approval to market exSALT(TM)

EDMONTON, Aug. 5 /PRNewswire/ - Exciton Technologies Inc. today announced that the Company has received approval from the United States Food and Drug Administration (FDA) to market exSALT(TM) SD7 Wound Dressing, a product incorporating Exciton's patented platform coating technology utilizing silve...

DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointestinal GVHD

PRINCETON, N.J., Aug. 4 /PRNewswire-FirstCall/ -- DOR BioPharma, Inc., (OTC Bulletin Board: DORB) (DOR or the Company), a late-stage biopharmaceutical company, announced today that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted Or...

AEterna Zentaris Partner, Keryx, Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial with Perifosine (KRX-0401) for the Treatment of Multiple Myeloma

QUEBEC CITY, Aug. 3 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: AEZS , TSX: AEZ), ("the Company") a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX ), its partner and licensee for perifosi...

Advanced Life Sciences Receives Complete Response Letter From FDA for Restanza(TM) (Cethromycin) in Community Acquired Pneumonia

CHICAGO, July 31 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS) announced that it received a complete response letter today from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Restanza(TM) (cethrom...

Anadys Pharmaceuticals Receives FDA Clearance of Phase II Protocol to Study ANA598 in Combination With Interferon-Alpha and Ribavirin in HCV Patients

SAN DIEGO, July 30 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS ) today announced finalization of the protocol for the Company's Phase II trial of ANA598 in combination with pegylated interferon-alpha and ribavirin in hepatitis C patients. Allowance o...

United States FDA Clears the REGEN Trial to Test Bioheart's Combination Gene and Stem Cell Therapy in Heart Failure Patients

SUNRISE, Fla., July 28 /PRNewswire-FirstCall/ -- Bioheart, Inc., (OTC Bulletin Board: BHRT) a company committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases announced today that the US FDA cleared a p...

Angiotech Pharmaceuticals announces FDA approval of TAXUS(R) Liberte(R) Long Stent

VANCOUVER, July 16 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI , TSX: ANP) today announced that its corporate partner, Boston Scientific Corporation (NYSE: BSX ) has received approval from the U.S. Food and Drug Administration (FDA) to market its TAXUS(R) Liberte(R) ...

Sumavel(TM) DosePro(TM) (sumatriptan injection) Approved by FDA for Acute Migraine and Cluster Headache: First Product Featuring Novel DosePro Needle-Free Delivery System

SAN DIEGO, July 16 /PRNewswire/ -- Zogenix, Inc. ("Zogenix"), a privately held pharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Sumavel DosePro (sumatriptan injection) needle...

ParagonRx Files with FDA REMS Panel Interim Analysis for Opioid Drugs Study

WILMINGTON, Del., July 15 /PRNewswire/ -- ParagonRx, a healthcare consulting leader in risk management and the appropriate use of drugs, has filed its interim analysis of a study that shows how its proprietary approach to risk management can help manufacturers of opioid drugs meet FDA standar...

Jesup & Lamont Announces Presenting LifeTech Companies and Former FDA Commissioner at Annual Growth Stock & National Sales Conference

NEW YORK, July 13 /PRNewswire-FirstCall/ -- Jesup & Lamont, Inc., (Amex: JLI ), a full-service boutique brokerage and investment banking firm serving retail and institutional clients, today announced the LifeTech Capital Group companies presenting at its 2009 Growth Stock & National Sale...

PharmAthene's 2nd Generation rPA Anthrax Vaccine, SparVax(TM), Completes FDA Regulatory Strategy Review

ANNAPOLIS, Md., July 9 /PRNewswire-FirstCall/ -- PharmAthene, Inc. (NYSE Amex: PIP ), a biodefense company developing medical countermeasures against biological and chemical threats, today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company's propos...

Mylan Receives FDA Approval for Generic Version of Prostate Cancer Treatment Casodex(R)

PITTSBURGH, July 7 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL ) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Bicalutamide Tablets, 50 mg. Bical...

Immucor Responds To FDA Notice

NORCROSS, Ga., June 26 /PRNewswire-FirstCall/ -- Immucor, Inc., (Nasdaq/NM: BLUD), a global leader in providing automated instrument-reagent systems to the blood transfusion industry, announced that yesterday the Food and Drug Administration ("FDA"), in an administrative action based on ...

Berlin Heart Inc. Receives FDA Orphan Product Development Grant

THE WOODLANDS, Texas, June 17 /PRNewswire/ -- Berlin Heart Inc. today announced it has been awarded an Orphan Product Development Grant by the FDA, to support the ongoing Investigational Device Exemption (IDE) study of the EXCOR(R) Pediatric Ventricular Assist Device (VAD). Dr. Christopher Alm...

Cumberland Pharmaceuticals Announces FDA Approval of Caldolor(TM)

New drug is first injectable product approved for sale in the United Statesfor treatment of pain and fever NASHVILLE, Tenn., June 11 /PRNewswire/ -- Cumberland Pharmaceuticals ( www.cumberlandpharma.com ) today announced the U.S. Food and Drug Administration (FDA) has approved Caldolor(T...

STAAR Surgical Receives FDA Clearance for the Epiphany(TM) Injector System

MONROVIA, Calif., June 11 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA ), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced that the FDA has granted 510(k) clearance for its Epiphany Injector System for use with the Affini...

EyeIC Receives FDA 510(k) Clearance for MatchedFlicker(TM) Retinal Aid Detection Technology

New technology to address issue of interpretation, storage and documentation of photograph files focused on progression of glaucoma NARBERTH, Pa., June 10 /PRNewswire/ -- EyeIC, an innovator of eye care solutions for ophthalmologists and optometrists, announced today that its MatchedFlicker(...

Angiotech Pharmaceuticals announces FDA 510(k) clearance of the Option(TM) Inferior Vena Cava Filter

VANCOUVER, June 8 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI , TSX: ANP) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Option(TM) Inferior Vena Cava (IVC) Filter in the United States, for use in both permanent an...

D-Pharm Receives FDA Clearance to Commence a Phase III Trial of DP-b99 in Acute Stroke Patients

REHOVOT, Israel, June 8 /PRNewswire/ -- D-Pharm announced today that its Investigational New Drug (IND) application for a pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients has been approved by the US Food and Drug Administration (FDA). D-Pharm plans to initiate the t...

Photos: FDA Approves 12-Month Labeling Update for EVOLENCE(R) Collagen-Based Facial Filler

First and Only Collagen-Based Filler Proven To Last Through One Year HERZLIYA, Israel and SKILLMAN, N.J., June 8 /PRNewswire/ -- Ortho Dermatologics today announced that the U.S. Food and Drug Administration (FDA) approved a labeling supplement which includes efficacy and safety data through ...

EarlySense's EverOn(TM) System Receives FDA Clearance and CE Mark Certification

RAMAT GAN, Israel, June 8 /PRNewswire/ -- EarlySense announced today that its EverOn contact-free patient supervision system has been cleared for marketing by the U.S. Food and Drug Administration and has received a CE Mark certification from KEMA, a Dutch notified body, in accordance with the...

Mylan Receives Tentative FDA Approval for Generic Version of Singulair(R)

PITTSBURGH, May 29 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL ) today announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Montelukast Sodium Tablets, 10 mg (base). Montelukast Sodium Ta...

Astellas Receives FDA Approval for Use of Prograf(R) (Tacrolimus) in Conjunction With Mycophenolate Mofetil (MMF) in Kidney Transplant Recipients

DEERFIELD, Ill., May 28 /PRNewswire/ -- The Food and Drug Administration (FDA) has granted Astellas Pharma US, Inc. approval for the use of Prograf(R) (tacrolimus) in conjunction with mycophenolate mofetil (MMF) for the prevention of organ rejection in kidney transplant recipients. Prograf is a c...

Agendia Supports Genentech's Citizen's Petition Urging FDA to Hold In-Vitro Diagnostic Tests to One Set of Scientific and Regulatory Standards

HUNTINGTON BEACH, California, and AMSTERDAM, May 28 /PRNewswire/ -- Agendia, a world leader in molecular cancer diagnostics, today announced its strong support of Genentech's Citizen's Petition. Filed on December 5, 2008, Docket No. FDA-2008-P-0638-0001/CP petitions that all in vitro diagnosti...

Angiotech Pharmaceuticals announces FDA approval of next-generation TAXUS(R) Liberte(R) Atom(TM) Stent system

VANCOUVER, May 27 /PRNewswire-FirstCall/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI , TSX: ANP) today announced that its corporate partner, Boston Scientific Corporation (NYSE: BSX ) has received approval from the U.S. Food and Drug Administration (FDA) to market its TAXUS(R) Liberte(R) A...

Signostics Receives FDA Clearance for World's Smallest Ultrasound Product

PALO ALTO, Calif., May 19 /PRNewswire/ -- Pioneering medical device company Signostics announced today it has secured clearance from the U.S. Food and Drug Administration (FDA) for its palm-sized personal ultrasound device, the 'Signos'. (Photo: http://www.newscom.com/cgi-bin/prnh/20090519/S...

U.S. FDA Accepts Aridol(TM) New Drug Application for Review

SYDNEY, Australia, May 13 /PRNewswire-Asia/ -- Pharmaxis (ASX: PXS; Nasdaq: PXSL ) today announced it had received notification from the United States Food and Drug Administration (FDA) that the New Drug Application (NDA) for its mannitol bronchial challenge test Aridol(TM) has been accepted...

Nerviano Medical Sciences Receives Approval From the FDA to Enter Phase I Clinical Trials for Their Polo Like Kinase (PLK) Inhibitor

NERVIANO, Italy, May 13 /PRNewswire/ -- The FDA has approved an Investigational New Drug (IND) application by Nerviano Medical Sciences to begin a phase I clinical study with its selective PLK-1 small molecule inhibitor for the treatment of cancer. PLK-1 is a mitotic kinase required for the pr...

Savient Announces New Date for FDA Arthritis Advisory Panel Review of KRYSTEXXA(TM) for Treatment Failure Gout

EAST BRUNSWICK, N.J., May 7 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT ) today announced that its biologics license application (BLA) for KRYSTEXXA (TM) (pegloticase), a novel biological drug for treatment failure gout (TFG) patients, will be reviewed by the Arthritis...

Novagali Pharma Announces FDA Clearance of IND for Phase III of Catioprost(R), its Cationic Emulsion of Latanoprost in Patients With Glaucoma

EVRY, France, May 5 /PRNewswire/ -- Novagali Pharma, a French pharmaceutical ophthalmic company, announces today that the Company's Investigational New Drug Application (IND) to conduct a Phase III clinical trial of Catioprost(R) (Nova21027), for the treatment of glaucoma has been granted by t...

Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes

SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., May 5 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN ), Eli Lilly and Company (NYSE: LLY ) and Alkermes, Inc. (Nasdaq: ALKS ) today announced that a New Drug Application (NDA) for exenatide once weekly has been submitted...

BioSpecifics Technologies Corp. Announces FDA Acceptance of Biologics License Application With Priority Review for XIAFLEX(TM) for the Treatment of Dupuytren's Disease

LYNBROOK, N.Y., April 28 /PRNewswire-FirstCall/ -- BioSpecifics Technologies Corp. (Nasdaq: BSTC ), a biopharmaceutical company developing first in class collagenase-based products, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (B...

OncoGenex Receives Confirmation from FDA on the Design of a Second Phase 3 Trial Evaluating OGX-011 for the Treatment of Advanced Prostate Cancer

FDA confirms durable pain palliation as an acceptable primary endpoint for a regulatory submission in support of market approval BOTHELL, WA, April 28 /PRNewswire-FirstCall/ - OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI ) announced today that the company has reached an agreement...

ETEX Corporation Announces FDA Clearance of Small Size Beta-bsm(TM) Injectable Paste and Gamma-bsm(TM) Moldable Putty

CAMBRIDGE, Mass., April 27 /PRNewswire/ -- ETEX Corporation, a leading orthopaedic biomaterials company, announced today FDA 510k clearance of 1cc and 2.5cc sizes of Beta-bsm(TM) Injectable Paste and Gamma-bsm(TM) Moldable Putty to complement the existing 5cc and 10cc sizes. Both products are bone...

Intercell to Host Conference Call and Webcast Today on FDA Approval of IXIARO(R) Japanese Encephalitis Vaccine

VIENNA, March 31 /PRNewswire/ -- Intercell AG (VSE: ICLL) today announced that it will host a conference call today to discuss the U.S. Food and Drug Administration's (FDA) approval of IXIARO(R), a new vaccine for the prevention of Japanese Encephalitis (JE). The initial target for use of Intercel...

Intercell Announces FDA Approval of IXIARO(R), a Novel Vaccine to Prevent Japanese Encephalitis

- U.S. FDA approves Intercell's first marketed product, a new vaccine against Japanese Encephalitis for travelers and military personnel - Commercial product launch in the U.S. planned for Q2 2009 VIENNA, March 30 /PRNewswire/ -- Intercell AG (VSE: ICLL) today announced that the U.S. Fo...

Mylan's Matrix Receives First Tentative FDA Approval Under PEPFAR for Generic Truvada(R)

PITTSBURGH, March 30 /PRNewswire-FirstCall/ -- Mylan Inc. (Nasdaq: MYL ) today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.2% controlling interest, has received the first tentative approval from the U.S. Food and Drug Administration (FDA) under t...

Bavarian Nordic Has Essentially Agreed a Pathway for the Licensure of IMVAMUNE(R) With the FDA After Successful End of Phase II Meeting

KVISTGAARD, Denmark, March 3 /PRNewswire-FirstCall/ -- Following the completion of the Phase II clinical development of IMVAMUNE(R), a third-generation smallpox vaccine, Bavarian Nordic has held an end of Phase II meeting with the FDA to discuss the Phase III development. The meeting was a suc...

Advanced Life Sciences Receives Notice of Planned Cethromycin Review by FDA Advisory Committee

CHICAGO, Feb. 27 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS ), announced today that it has received notice from the U.S. Food and Drug Administration (FDA) that the agency's Anti-Infective Drugs Advisory Committee (AIDAC) is tentatively scheduled to meet on Jun...
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