Bedford Laboratories First to Manufacture FDA Approved Indomethacin for Injection USP
FDA Announces Possible Safety Concern for HIV Drug Combination
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FDA Advisory Committee Recommends Approval of InterMune's Esbriet(R) (pirfenidone) for Idiopathic Pulmonary Fibrosis
BRISBANE, Calif., March 9, 2010 -- InterMune, Inc. (Nasdaq: ITMN) announced today that the U.S. Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 9-3 to recommend approval of...
Agendia Receives New York State Laboratory Permit and Laboratory Accreditation by College of American Pathologists
HUNTINGTON BEACH, CA, and AMSTERDAM, THE NETHERLANDS, February 9, 2010 -Agendia, a world leader in molecular cancer diagnostics, announced today that it has received the Clinical Laboratory Permit from the New York...
ISTA Pharmaceuticals Receives Action Date for FDA Review of Once-Daily XiDay(TM)
IRVINE, Calif., March 8, 2010 -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced the Company's supplemental New Drug Application (sNDA) for once-daily XiDay(TM) (bromfenac ophthalmic solution) has been...
ImmunoGen, Inc. Announces Orphan Drug Designation Granted to IMGN901 for Treatment of Merkel Cell Carcinoma by US FDA and EU COMP
WALTHAM, Mass., Mar 08, 2010 -- ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, today...
Acura Pharmaceuticals and King Pharmaceuticals Announce Positive Top Line Results of a Clinical Study Assessing Relative Abuse Potential
PALATINE, ILLINOIS and BRISTOL, TENNESSEE- March 8, 2010 - Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) and King Pharmaceuticals, Inc. (NYSE: KG) today announced top-line results from Study AP-ADF-114 ("Study 114") titled...
Lilly to Acquire European Rights to Pfizer Animal Health Assets
GREENFIELD, Ind., March 8, 2010 -- Elanco, the animal health division of Eli Lilly and Company (NYSE: LLY), today announced that Lilly has signed an agreement to acquire the European rights to a portfolio of certain...
FDA Approves NerPharMa to Manufacture Cell Therapeutics' Drug Pixantrone
SEATTLE, March 8, 2010 -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced that the U.S. Food and Drug Administration ("FDA") has completed its inspection of the facility at NerPharMa (a...
FDA Update on the Investigation into the Salmonella Montevideo Outbreak
March 5, 2010 - As part of the Salmonella Montevideo investigation, the Food and Drug Administration has been actively investigating the supply chain of black and red pepper supplied to Daniele International Inc.,...
Paradigm Medical (PMED) Announces New Glaucoma Test
SALT LAKE CITY, UT--(March 05, 2010) - Paradigm Medical Industries, Inc. (PINKSHEETS: PDMI) announced today that it has been notified by its Italian partner, Costruzione Strumenti Oftalmici (CSO), that all necessary...
InterMune Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on Pirfenidone
BRISBANE, Calif., March 5, 2010 -- InterMune, Inc. (Nasdaq: ITMN) announced today that the U.S. Food and Drug Administration (FDA) has posted briefing documents for the March 9 Pulmonary-Allergy Drugs Advisory Committee...
Successful Inspection by FDA of Almac Clinical Services North Carolina Facility
05-MAR-10--Almac Clinical Services is pleased to announce the completion of a successful inspection of its Durham, North Carolina facility by the US Food and Drugs Administration (FDA) on Monday 22nd February.
XenoPort Restructures to Focus on Key Programs
SANTA CLARA, Calif., Mar 05, 2010 -- XenoPort, Inc. (Nasdaq:XNPT) announced today a restructuring that includes an overall reduction in its workforce of approximately 50%. The restructuring is designed to focus the...
Hanmi wins the best drug research award of KDRA
March 04, 2010 - Hanmi was awarded the best drug research award from KDRA (Korea drug research association) on February 26. This award, supported by the Ministry for health welfare and family affairs, Ministry of...
FDA Approves Name Change for Heartburn Drug Kapidex
March 4, 2010 - The U.S. Food and Drug Administration has approved a name change for the heartburn drug Kapidex (dexlansoprazole) to avoid confusion with two other medications - Casodex and Kadian. Effective in late...
Salmonella Tennessee Identified in a Processed Food Ingredient
March 4, 2010 - The U.S. Food and Drug Administration is taking steps to protect the public following the early identification of Salmonella Tennessee in one company's supply of hydrolyzed vegetable protein (HVP). This...
NicOx 2009 Financial Results
March 4, 2010. Sophia Antipolis, France - NicOx S.A. (NYSE Euronext Paris: COX) today announced its financial results for full year 2009 and provided an overview of its activities, in particular those related to its...
SpePharm announces the acquisition of Savene
Amsterdam, March 4, 2010 - SpePharm Holding, BV today announced the acquisition of the worldwide (with the exception of North and South America) rights to Savene
FDA Calls on Food Companies to Correct Labeling Violations; FDA Commissioner Issues an Open Letter to the Industry
March 03, 2010 - The U.S. Food and Drug Administration has notified 17 food manufacturers that the labeling for 22 of their food products violates the Federal Food, Drug, and Cosmetic Act.
FDA, FSIS, CDC Collaborate on Methods to Measure Success of Food Safety Programs
March 3, 2010 - The U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) will host a joint public workshop...
FDA Warns Consumers in Puerto Rico of Harmful Bacteria in Hand Sanitizers
March 3, 2010 - The U.S. Food and Drug Administration is warning consumers in Puerto Rico that two hand sanitizers - "Bee-Shield Hand Sanitizer" with Aloe Vera (10 fl. oz. or 1 gallon bottles) and "MD Quality Hand...
Endocyte announces DSMB supports continuation of phase 2 PRECEDENT study
WEST LAFAYETTE, Ind. - March 03, 2010 - Endocyte, Inc., a biotech company developing guided therapeutics and diagnostics for personalized medicine, has announced that an independent data safety monitoring board (DSMB)...
Covidien Launches Oral Transmucosal Fentanyl Citrate Product
ST. LOUIS, Mar 03, 2010 -- Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that Mallinckrodt Inc., a Covidien company, has launched its Oral Transmucosal Fentanyl Citrate (CII) to...
<< Back Synta Announces Elesclomol Clinical Development to Resume
LEXINGTON, Mass., Mar 02, 2010 -- Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions,...
Phase Forward to Participate in Key Industry Events in March
WALTHAM, Mass., Mar 02, 2010 -- Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, will participate in four industry events this month including DIA's 22nd...
Exactech Platform Fracture Stem for Shoulder Surgeries Receives FDA Clearance
GAINESVILLE, Fla. - March 2, 2010 -- Exactech Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today that the company...
Edwards SAPIEN XT Transcatheter Valve and Delivery Systems Receive CE Mark
IRVINE, CA, March 02, 2010 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received CE Mark for its Edwards SAPIEN...
Antares Pharma, Inc. (ANTR) Announces Completion of Patient Enrollment in Phase 3 Pivotal Trial of Anturol(TM) for the Treatment of Overactive Bladder
EWING, N.J.--March 02, 2010--Antares Pharma, Inc. (NYSE Amex: AIS) announced today that it has completed enrollment in the double-blind portion of the Company's Phase 3 clinical trial of Anturol(TM), its transdermal...
FDA Approves Exalgo(TM) Extended-Release Tablets
CAMBRIDGE, Mass., Mar 02, 2010 -- CombinatoRx, Incorporated (NASDAQ: CRXX) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Exalgo(TM) (hydromorphone HCl)...
Advanced Cell Technology's RPE Cells Granted Orphan Drug Status from FDA for Treatment of Stargardt's Macular Dystrophy
WORCESTER--March 02, 2010--Advanced Cell Technology, Inc. (OTCBB: ACTC - News), a biotechnology company applying cellular technology in the field of regenerative medicine, announced today that the U.S. Food and Drug...
FDA Approves EXALGO(TM) (Hydromorphone HCL) Extended-Release Tablets
ST. LOUIS, Mar 02, 2010 -- Covidien (NYSE:COV) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application 21-217 for EXALGO(TM) (hydromorphone HCl) Extended-Release Tablets,...
KALBITOR(R) (ecallantide) Data Presented at American Academy of Allergy, Asthma and Immunology Annual Meeting
CAMBRIDGE, Mass., Mar 02, 2010 -- Datademonstrating the effectiveness of KALBITOR (ecallantide) to treat hereditary angioedema (HAE) acute attacks by primary attack location were provided in an oral presentation...
FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland
March 2, 2010 - The U.S. Food and Drug Administration today approved the first generic version of Flomax Capsules 0.4 mg (tamsulosin hydrochloride) to treat benign prostatic hyperplasia (BPH), a condition in which an...
FDA Survey Finds More Americans Read Information on Food Labels
March 2, 2010 - A majority of consumers read food labels and are increasingly aware of the link between good nutrition and reducing the risk of disease, according to the latest survey of dietary habits released today by...
InterMune Announces Submission of MAA for Pirfenidone for the Treatment of Patients With IPF
BRISBANE, Calif., March 2, 2010 -- InterMune, Inc. (Nasdaq: ITMN) today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market...
Lux Biosciences Receives Acceptance of Luveniq(TM) MAA Filing from European Medicines Agency
JERSEY CITY, N.J., March 2, 2010 -- Lux Biosciences, Inc. today announced that the European Medicines Agency (EMA) has accepted the filing of the company's Marketing Authorization Application (MAA) for the company's...
Impax Laboratories Receives Final FDA Approval for Generic FLOMAX(R) 0.4mg Capsules and Immediately Commences Shipment
HAYWARD, Calif., Mar 02, 2010 -- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application...
Mylan Receives Approval for Generic Version of Actigall
PITTSBURGH, March 2, 2010 -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug...
ADVENTRX Receives Refuse to File Letter from FDA on ANX-530 New Drug Application
SAN DIEGO, March 1, 2010 -- ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it received a refuse to file letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application...
AdvaMed Supports Comprehensive IOM Review of FDA 510(k) Process
WASHINGTON, D.C. -March 01, 2010 Janet Trunzo, executive vice president for technology and regulatory affairs for the Advanced Medical Technology Association (AdvaMed), released the following statement in response to...
FDA Sets March 22 for ODAC Meeting to Review CTI's New Drug Application for Pixantrone
SEATTLE, March 1, 2010 -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration's ("FDA") Oncologic Drugs Advisory Committee ("ODAC") will review CTI's New...
ARIAD Receives Orphan Drug Designations for Its Investigational pan BCR-ABL Inhibitor, AP24534, in Chronic Myeloid Leukemia
CAMBRIDGE, Mass., Mar 01, 2010 -- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that its investigational pan-BCR-ABL inhibitor, AP24534, has been granted orphan drug designation by both the U. S. Food and...
VIVUS Announces FDA Acceptance of Qnexa(R) New Drug Application for Treatment of Obesity
MOUNTAIN VIEW, Calif., March 1, 2010 -- VIVUS, Inc. (Nasdaq: VVUS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's new drug application (NDA) for its...
NovoStent Receives CE Mark for New Class of Endovascular Implant
MOUNTAIN VIEW, Calif.--March 1, 2010--NovoStent
Acorda Therapeutics Announces Availability of AMPYRA(TM) (dalfampridine)
HAWTHORNE, N.Y., Mar 01, 2010 -- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that AMPYRA(TM) (dalfampridine) Extended Release Tablets, 10 mg is now available by prescription in the United States and Puerto...
European Data Suggest Switching Patients to IgPro20 May Significantly Reduce Drug Administration Volume
King of Prussia, PA -- 01 March 2010--Data from a European multicenter (non-IND study) showing that patients with PI who switched to IgPro20 from previously available SCIg formulations achieved comparable IgG trough...
European Data Suggest Switching Patients to IgPro20 May Significantly Reduce Drug Administration Volume
King of Prussia, PA -- 01 March 2010--Data from a European multicenter (non-IND study) showing that patients with PI who switched to IgPro20 from previously available SCIg formulations achieved comparable IgG trough...
FDA Accepts VIAject(R) NDA for Review
DANBURY, Conn., Mar 01, 2010 -- Biodel Inc. (Nasdaq: BIOD) announced today that the U.S. Food and Drug Administration has accepted for review the company's new drug application (NDA) seeking approval to market...
Medicis Presents the Dysport(TM) Challenge: Love It or Leave It
SCOTTSDALE, Ariz., March 1, 2010 -- Medicis (NYSE:MRX) today announced the launch of its new program, the "Dysport Challenge." Approved by the U.S. Food and Drug Administration (FDA) in April 2009, Dysport...
FDA Announces Meeting Information and Voting Membership of the Tobacco Products Scientific Advisory Committee
March 1, 2010 - The U.S. Food and Drug Administration today announced membership and meeting information for the Tobacco Products Scientific Advisory Committee (TPSAC). The Committee, required through the Family Smoking...
Vion Receives Response from FDA on Special Protocol Assessment for Onrigin(TM)
NEW HAVEN, CT, February 26, 2010 - VION PHARMACEUTICALS, INC. (OTC BULLETIN BOARD: VIONQ) announced today that it had received a response from the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment...
FDA Approves Therapy to Treat Gaucher Disease
Februar 26, 2010 - The U.S. Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.
FDA Update on the Investigation into the Salmonella Montevideo Outbreak
February 26, 2010 - The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture's Food Safety and Inspection Service, continues to work closely with...
International Collaboration: FDA and European Medicines Agency Agree to Accept a Single Orphan Drug Designation Annual Report
Feb. 26, 2010 - In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced a more streamlined process to help regulators better identify and...
Exenatide Once Weekly New Drug Application Review Extended By FDA Due to Weather-Related Closure
SAN DIEGO, INDIANAPOLIS and WALTHAM, Mass., Feb. 25, 2010 -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today confirmed that the U.S. Food and Drug...
Symmetry Medical Reports Fourth Quarter and Full Year 2009 Financial Results Provides 2010 revenue and EPS guidance
WARSAW, Ind., Feb 25, 2010-- Symmetry Medical Inc. (NYSE: SMA), a leading independent provider of products to the global orthopaedic device industry and other medical markets, announced fourth quarter and full year 2009...
Dynavax Selects Clinical Candidate in Universal Flu Vaccine Program
BERKELEY, CA, Feb 25, 2010 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it has selected a clinical vaccine candidate for its novel Universal Flu program, completed key preclinical studies, and...
Sunesis Poised for Phase 3 Trial of Voreloxin in Acute Myeloid Leukemia After Completing Formal End-of-Phase 2 Meetings With FDA
SOUTH SAN FRANCISCO, CA, Feb 25, 2010 -- Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that it has completed formal End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) related to its...
Adolor Reports Year-End 2009 Financial Results
EXTON, Pa., Feb 25, 2010 -- Adolor Corporation (NasdaqGM: ADLR) today reported a net loss of $47.9 million, or $(1.03) per basic and diluted share, for the year ended December 31, 2009, compared to a net loss of $30.1...
FDA Update on the Investigation into the Salmonella Montevideo Outbreak
February 25, 2010 - The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture's Food Safety and Inspection Service, continues to work closely with...
Theratechnologies announces a tentative new date for the FDA Advisory Committee review of the tesamorelin New Drug Application
Montreal, Canada - February 25, 2010 - Theratechnologies (TSX:TH) today announced that the U.S. Food and Drug Administration ("FDA") has set a tentative new date of May 27, 2010 for the Endocrinologic and Metabolic...
FOUGERA
MELVILLE, N.Y. - February 25, 2010 - E. Fougera & Co., a leading specialty pharmaceutical manufacturer, today announced it has received first generic approval from the FDA for Imiquimod Cream 5% (Rx) [click here to...
Exenatide Once Weekly New Drug Application Review Extended By FDA Due to Weather-Related Closure
SAN DIEGO & INDIANAPOLIS & WALTHAM, Mass., Feb 25, 2010 -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today confirmed that the U.S. Food and Drug...
Exenatide Once Weekly New Drug Application Review Extended by FDA Due to Weather-Related Closure
SAN DIEGO & INDIANAPOLIS & WALTHAM, Mass., Feb 25, 2010-- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today confirmed that the U.S. Food and Drug...
Small Bone Innovations, Inc. Receives US FDA 510(k) Clearance for Mini-Rail Fixation System and Large Cannulated Screw System
NEW YORK--February 25, 2010--Small Bone Innovations, Inc. (SBi), a leading, privately-held orthopedics company focused exclusively on technologies and treatments for the small bones & joints, announced that it has...
Aurobindo Pharma receives tentative approval for its New Drug
25th February 2010--Aurobindo Pharma Limited is pleased to announce that it has received the tentative approval to manufacture and market Nevirapine Tablets for Oral Suspension 50mg (NDA) from the US Food & Drug...
Cleveland BioLabs Submits Response to Department of Defense Request for Proposal for Radiation Countermeasure
BUFFALO, N.Y., Feb 24, 2010 -- Cleveland BioLabs, Inc. (Nasdaq:CBLI) today announced that it has submitted a response to the Request for Proposal (RFP) issued by The Department of Defense (DoD) for the advanced...
Pfizer Receives FDA Approval for Prevnar 13(TM) for the Prevention of Invasive Pneumococcal Disease in Infants and Young Children
NEW YORK--February 24, 2010 --Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration (FDA) has granted approval for Prevnar 13(TM) (Pneumococcal 13-valent Conjugate Vaccine...
NIH and FDA Announce Collaborative Initiative to Fast-track Innovations to the Public
Feb. 24, 2010 - The U.S. Food and Drug Administration and the National Institutes of Health today unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new,...
FDA Approves Pneumococcal Disease Vaccine with Broader Protection
February 24, 2010 - The U.S. Food and Drug Administration today approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years. Prevnar 13 will be the...
Epigenomics AG Introduces New Lung Cancer Test at German Cancer Congress
Berlin, Germany, and Seattle, WA, U.S.A., February 24, 2010 - Epigenomics AG (Frankfurt, Prime Standard: ECX), a cancer molecular diagnostics company, introduces its novel lung cancer test at the ongoing 29th German...
Top Doctors to Present Results of FDA Clinical Trial of Guided Therapeutics' Cervical Cancer Detection Technology at Scientific Meeting
NORCROSS, GA (February 23, 2010) - Results of the U.S. Food and Drug Administration (FDA) pivotal clinical trial for the Guided Therapeutics, Inc. (GT) (Pink Sheets: GTHP) LightTouch(TM) Non-invasive Cervical Cancer...
PARI Pharma's Altera Delivers Gilead's Cayston, Approved by the U.S. FDA for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with Pseudomonas Aeruginosa
MONTEREY, CALIFORNIA, FEBRUARY 23, 2010 - Altera, which uses eFlow Technology, was cleared to market today by the FDA as the first drug-specific nebulizer for use in the treatment of patients with cystic fibrosis and...
Epigenomics AG: Blood Test for Colorectal Cancer Now Available Nationwide in Germany and Switzerland
Berlin, Germany, and Seattle, WA, U.S.A., February 23, 2010 - Only four months after launch, Epigenomics AG (Frankfurt, Prime Standard: ECX), a cancer molecular diagnostics company, today reported that its blood based...
Diagnostic Hybrids Receives FDA Emergency Use Authorization for D3 Ultra 2009 H1N1 Influenza A Virus ID Kit
SAN DIEGO, Feb 23, 2010-- Diagnostic Hybrids, a Quidel Company (NASDAQ: QDEL) has received emergency use authorization from the U.S. Food and Drug Administration (FDA) for its D3(R)UltraTM 2009 H1N1 Influenza A Virus ID...
Forest Laboratories Receives Decision from FDA for Supplemental New Drug Application for Bystolic(R)
NEW YORK, Feb 23, 2010 -- Forest Laboratories, Inc. (NYSE: FRX) announced today that the U.S. Food and Drug Administration (FDA) did not approve the additional indication for Bystolic(R) (nebivolol) tablets as a...
FDA Announces Possible Safety Concern for HIV Drug Combination
Feb. 23, 2010 - The U.S. Food and Drug Administration today announced preliminary data suggesting that Invirase (saquinavir) in combination with Norvir (ritonavir) may have potentially important adverse effects on the...
DURECT and Nycomed Amend POSIDUR(TM) License Agreement to Separate Funding and Control of U.S. and E.U. Clinical Programs and to Expand Territory
CUPERTINO, Calif., Feb 22, 2010 -- DURECT Corporation (Nasdaq: DRRX) announced today that Nycomed and DURECT have amended the Development and License Agreement entered into between the parties in 2006 covering the...
BioSante Pharmaceuticals Reports Positive LibiGel
LINCOLNSHIRE, Illinois (February 22, 2010) - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), today announced additional positive safety data in its ongoing LibiGel Phase III clinical development program. For the second...
FDA Clears Haemonetics 510(k) to collect 2RBC from More Female Donors
Braintree, MA, Feb. 22, 2010 - On January 27, 2010 the FDA cleared the Haemonetics (NYSE: HAE) 510(k) for its expanded nomogram to collect two Red Blood Cells on the Cymbal
U.S. Food and Drug Administration Approves Cayston(R) (Aztreonam for Inhalation Solution) for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with Pseudomonas Aeruginosa
FOSTER CITY, Calif., Feb 22, 2010 -- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston(R)(aztreonam for inhalation solution)...
Watson Files FDA Application for Generic Aplenzin(TM) ER
MORRISTOWN, N.J., Feb 22, 2010 -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc.- Florida, filed an...
Syneron Receives FDA Clearance for Expanded Indications of eMatrix(TM) Sublative Rejuvenation System Indication for Fine Line and Wrinkle Treatment Expands Product Versatility
YOKNEAM, ISRAEL -- 02/22/2010 -- Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, announced today expanded clearance from the U.S. Food and Drug Administration (FDA) for the eMatrix(TM)...
Star Scientific Files Application with FDA for Ariva-BDL(TM) Approval as First Modified Risk Tobacco Product
GLEN ALLEN, Va., Feb 22, 2010-- Star Scientific, Inc. (Nasdaq: CIGX) announced that on Friday, February 19 the company filed an application with the Food & Drug Administration for approval to market Ariva-BDL(TM) as a...
Novartis receives FDA approval of Menveo
Basel, February 22, 2010 - Novartis announced that Menveo
Novartis oral multiple sclerosis development compound Gilenia
Basel, February 22, 2010 - Gilenia
U.S. Food and Drug Administration Approves Cayston(R) (Aztreonam for Inhalation Solution) for the Improvement of Respiratory Symptoms in Cystic Fibrosis Patients with Pseudomonas Aeruginosa
FOSTER CITY, Calif., Feb 22, 2010 -- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston(R)(aztreonam for inhalation solution)...
GSK rejects conclusions of Senate Committee on Finance Staff Report on Avandia
Saturday, 20 February 2010, Research Triangle Park, NC - The Staff Report of the Senate Committee on Finance draws conclusions on the safety of Avandia (rosiglitazone) that are based on analyses that are not consistent...
Physio-Control Resumes Unrestricted Global Shipments of Its LifePak
REDMOND, WASH. - Feb. 19, 2010 - Physio-Control Inc., a wholly-owned subsidiary of Medtronic, Inc. (NYSE: MDT), announced today it received notice from the U.S. Food and Drug Administration (FDA) that having...
United Therapeutics Corporation Withdraws European Marketing Authorization Application for Tyvaso for the Treatment of Pulmonary Arterial Hypertension
SILVER SPRING, Md., Feb 19, 2010 -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that it has withdrawn its Marketing Authorization Application (MAA) for Tyvaso (treprostinil sodium) 0.6 mg/ml nebuliser...
European CHMP adopts negative opinion on ceftobiprole
Basel, Switzerland, February 19, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN) announces that the European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on the Marketing Authorization...
Regulatory Science Update: FDA and International Serious Adverse Events Consortium Complete Third Data Release
Feb. 19, 2010 - The U.S. Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC) today announced the third release of data on the genetic basis of drug-induced liver injury (DILI) and...
FDA Classifies Prolia(TM) (Denosumab) Complete Response Submission and Targets Action Date
THOUSAND OAKS, Calif., Feb 19, 2010 -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has evaluated the content of the Company's Complete Response submission for Prolia(TM)...
Novartis drug Tasigna
Basel, February 19, 2010 - Novartis announced today that Tasigna
US FDA approves Rituxan/MabThera for the most common type of adult leukemia
Basel, 19. February, 2010--Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) approved Rituxan/MabThera (rituximab) plus fludarabine and cyclophosphamide (FC) chemotherapy...
Medicis Begins Shipping RESTYLANE-L(TM) and PERLANE-L(TM)
SCOTTSDALE, Ariz., Feb. 18, 2010 -- Medicis (NYSE:MRX) today announced that the Company has begun shipment of the dermal fillers RESTYLANE-L(TM) and PERLANE-L(TM). On January 29, 2010, the U.S. Food and Drug...
Dynavax and GlaxoSmithKline Select Clinical Candidate in the Endosomal TLR Inhibitor Program
BERKELEY, CA, Feb 18, 2010 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the selection of a candidate for clinical development in its endosomal Toll-like Receptor (TLR) inhibitor collaboration with...
FDA Announces New Safety Controls for Long-Acting Beta Agonists, Medications Used to Treat Asthma
Feb. 18, 2010 - The U.S. Food and Drug Administration today announced that drugs in the class of long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults....
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