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Food and Drug Administration


Food and Drug Administration

The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

The FDA is responsible for protecting and promoting public health. It regulates and supervises food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), and veterinary products.

The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. The 21st and current Commissioner is Dr. Margaret A. Hamburg. She has served as Commissioner since February 2009.

The FDA has its headquarters at White Oak, Maryland. The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA started opening offices in foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.

Timeline

The FDA has reported on 15 Oct 2012 that the products that is linked to the growing Meningitis outbreak may also cause other types of infections in patients who have had eye operations or open-heart surgery. The new warning was issued based on two cases and it is not known for sure whether there the drugs had cause the infections.

Investigators of the FDA visit New England Compounding Center in Framingam, Mass on 16 October 2012 in connection to the deadly Meningitis outbreak.

Food and Drug Administration in News

FluoroPharma Names Dr. Thomas Tulip, PhD Chief Executive Officer
MONTCLAIR, NJ--(Marketwired - December 29, 2015) - FluoroPharma Medical, Inc. (OTCQB: FPMI), a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, announced today the appointment of Dr. Thomas Tulip, PhD as Chief Executive Officer.

Houston and New York Dermatologist Discusses CoolMini Non-Surgical Treatment for a Double Chin
According to a study by the American Society for Dermatologic Surgery in 2014, approximately 68 percent of people reported concerns about fat accumulation along the neck and under the chin. The appearance of a "double chin" can affect individuals of all shapes and sizes, even those who are of a healthy weight. Dr. Paul M

Basilea provides clinical program updates
Basilea Pharmaceutica AG /Basilea provides clinical program updates. Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

Actelion to discuss US FDA approval of Uptravi (selexipag) for the treatment of pulmonary arterial hypertension
Actelion Pharmaceuticals Ltd /Actelion to discuss US FDA approval of Uptravi (selexipag) for the treatment of pulmonary arterial hypertension . Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

Actelion receives US FDA approval of Uptravi (selexipag) for the treatment of pulmonary arterial hypertension
Actelion Pharmaceuticals Ltd /Actelion receives US FDA approval of Uptravi (selexipag) for the treatment of pulmonary arterial hypertension . Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

Bio-Rad's TANGO infinity Receives FDA 510(k) Clearance for U.S. Markets
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a global provider of life science research and clinical diagnostic products, today announced that it has received U.S. Food and Drug Administration clearance to market its TANGO infinity® system in the U.S. The system automates routine blood typing and screening testing procedures for patients and donors.

Alkame Holdings, Inc. Files 10-Q
Alkame Holdings, Inc. (OTC: ALKM), a publicly traded health and wellness technology holding company with a focus on patentable, innovative, and eco-friendly products, announced that it filed its quarterly report on form 10-Q for the first quarter or three-month period ended March 31, 2015 with the Securities and Exchange Commission, as permitted under rule 12b-25.

Breakthrough Medicines Usher in Hopeful Era for Lung Cancer Patients
SAN CARLOS, CA--(Marketwired - December 17, 2015) - The Bonnie J. Addario Lung Cancer Foundation (ALCF) applauds the medical research community and the U.S. Food and Drug Administration (FDA) for putting a heightened focus on lung cancer diagnostics and treatments

Biodel Reports Fourth Quarter and Fiscal Year 2015 Financial Results
DANBURY, CT--(Marketwired - December 17, 2015) - Biodel Inc. (NASDAQ: BIOD) today reported financial results for the fourth fiscal quarter and year-ended September 30, 2015

Acura Pharmaceuticals Provides Development Update on Its LIMITX(TM) Abuse Deterrent Technology
PALATINE, IL--(Marketwired - December 17, 2015) - Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), a specialty pharmaceutical company innovating abuse deterrent drugs, today announced that's it is advancing its lead LIMITX™ oral abuse deterrent drug candidate using the opioid hydromorphone HCl (LIMITX Hydromorphone) into clinical testing

Medigene AG announces key Management Changes
Medigene AG /Medigene AG announces key Management Changes. Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

Cortex Pharmaceuticals, Inc. Announces Name Change and Symbol Change
Cortex Pharmaceuticals, Inc. (OTC: CORX) (the "Company") is providing investors and shareholders with a 2015 year-end update and a summary overview of the Company's clinical trial plans for 2016.

Bio-Rad Receives FDA Clearance for Its D-100 System for A1c Testing
HERCULES, CA--(Marketwired - December 16, 2015) - Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a global provider of life science research and clinical diagnostic products, today announced that its D-100™ System for A1c testing has obtained clearance from the U.S

NeuroRx Provides Clinical Development Update for Cyclurad(TM), a Novel Treatment for Acute Suicidal Crisis in Bipolar Disorder
NeuroRx, a clinical stage pharmaceutical company developing novel therapeutics for the treatment of central nervous system disorders, today announced its plans for advancing Cyclurad™, the company's lead drug candidate, into a Phase II/III clinical trial for the treatment of acute suicidal crisis associated with bipolar depression

TissueGen's New ISO Class 7 Facility Supports FDA cGMP Drug Product Manufacturing
TissueGen® Inc., developer of ELUTE® fiber, a groundbreaking biodegradable fiber format for advanced drug delivery, today announced the completion of significant facility upgrades now enabling TissueGen to manufacture and develop ELUTE fiber in an ISO Class 7 cleanroom environment to support the Food and Drug Administration's cGMP regulations for manufacturing drug product.

Betancourt Nutrition Introduces BCAA Plus With Sustamine(R) L-Alanyl-L-Glutamine
NEW YORK, NY--(Marketwired - December 15, 2015) - Betancourt Nutrition is introducing BCAA Plus with Sustamine® L-Alanyl-L-Glutamine this December. It contains 1,500mg of Sustamine® and Taurine for better water absorption.*

Trident Brands Appoints Dr. Julian E. Bailes Special Advisor to Brain Armor
Trident Brands, Inc. (OTCQB: TDNT), is pleased to announce the appointment of Dr. Julian E. Bailes as a Special Advisor to Brain Armor®.

Merck and Pfizer Advance Clinical Development Program with Two Additional Phase III Trials of Avelumab
Business Wire IndiaMerck and Pfizer announced the opening of trial sites for an international Phase III study of avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in patients with platinum-resistant/refractory ovarian cancer

Now Made in India: Human Mini-Livers
Business Wire IndiaPandorum Technologies Pvt. Ltd., the Bangalore-based biotechnology startup working on tissue engineering, announced today that it has developed artificial tissue that performs the functions of the human liver. These 3D printed living tissues enable affordable medical research with reduced animal and human trials, and will eventually lead to full scale transplantable organs

Boehringer Ingelheim 3rd-generation EGFR TKI, BI 1482694, receives FDA Breakthrough Therapy Designation in lung cancer
Business Wire IndiaBoehringer Ingelheim today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for its novel, 3rd-generation, epidermal growth factor receptor (EGFR) mutation-specific tyrosine kinase inhibitor (TKI), BI 1482694* (HM61713**)

Novus Is Building Proprietary Software System to Handle Membership Growth
Novus Acquisition & Development Corp (OTC PINK: NDEV), wholly owned subsidiary Novus Medical Group, Inc., a service provider of the health and wellness savings plan, "Novus MedPlan," announces that it has retained PR Revolution (http://www.prrevolution.com) to build a proprietary software platform to handle rapid growth.

First in the world regulatory approval of Novartis' Cosentyx(TM) in Japan for both psoriasis and psoriatic arthritis
Novartis International AG /First in the world regulatory approval of Novartis' Cosentyx(TM) in Japan for both psoriasis and psoriatic arthritis . Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

Horizon Pharma plc Files Patent Infringement Lawsuit Against Watson Laboratories, Inc. for Filing an ANDA Against PENNSAID(R) 2%
Horizon Pharma plc (NASDAQ: HZNP), a specialty biopharmaceutical company with a portfolio of products in arthritis, inflammation and orphan diseases, announced today that the Company has filed a patent infringement lawsuit in the United States District Court for the District of New Jersey against Watson Laboratories, Inc

Canna-Pet(TM) Happy New Year Sale
Canna-Pet™ celebrates the New Year with 20% off all orders over $75! Canna-Pet™, the leading innovator of over-the-counter cannabinoid products for animals, announces the launch of its "Happy New Year Sale." Sale starts today and runs until midnight on January 3.

Acura Pharmaceuticals Acknowledges Distribution of Nexafed(R) by Kmart Pharmacy
PALATINE, IL--(Marketwired - December 23, 2014) - Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), today acknowledged the announcement by Kmart Pharmacy that Kmart is stocking NEXAFED [pseudoephedrine hydrochloride (HCl)], Acura's next generation pseudoephedrine with methamphetamine-resistant IMPEDE technology, in all Kmart in-store pharmacies nationwide (http://www.pharmacytimes

Cytokinetics and Astellas Announce Expansion of Collaboration for Development of CK-2127107 in Spinal Muscular Atrophy and Other Neuromuscular Indications
Cytokinetics Expects to Receive Over $75 Million in Committed Capital and Reimbursements For Planned Activities  

Novo Nordisk receives FDA approval for Saxenda® for the treatment of obesity
Bagsværd, Denmark, 23 December 2014 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Saxenda® (liraglutide 3 mg), the first once-daily human glucagon-like peptide-1 (GLP-1) analogue for the treatment of obesity

ContraFect Receives FDA Approval to Initiate Clinical Trials of CF-301 for MRSA Bloodstream Infections
ContraFect Corporation (NASDAQ: CFRX) (NASDAQ: CFRXW) (NASDAQ: CFRXZ), a biotechnology company focused on the discovery and development of protein therapeutics and antibody products for life-threatening, drug-resistant infectious diseases, announced today that the U.S

Actelion submits US FDA New Drug Application for selexipag (Uptravi) in patients with pulmonary arterial hypertension
Actelion Pharmaceuticals Ltd /Actelion submits US FDA New Drug Application for selexipag (Uptravi) in patients with pulmonary arterial hypertension . Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

TiGenix submits its pivotal US trial design for Cx601 to the FDA for Special Protocol Assessment

Sobi's Xiapex receives positive opinion by CHMP for the treatment of Peyronie's disease
Swedish Orphan Biovitrum AB (publ) (Sobi) and partner Auxilium Pharmaceuticals, Inc

PEH's Portfolio Company Enanta announces U.S. FDA Approval for AbbVie's VIEKIRA PAK(TM)
Private Equity Holding AG /PEH's Portfolio Company Enanta announces U.S. FDA Approval for AbbVie's VIEKIRA PAK(TM) . Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

Flamel Technologies Announces Positive Results of a Second Clinical Trial With Micropump(R) Sodium Oxybate
Flamel Technologies (NASDAQ: FLML) today announced that its second clinical study in healthy volunteers using its proprietary Micropump® technology applied to sodium oxybate has achieved the objective of one single dose before bedtime for patients suffering from narcolepsy, confirming the results of a previous, first-in-man, study

Biodel Reports Fourth Quarter Fiscal Year 2014 Financial Results
DANBURY, CT--(Marketwired - December 17, 2014) - Biodel Inc. (NASDAQ: BIOD) today reported financial results for the fourth fiscal quarter ended September 30, 2014.

Quidel Receives Simultaneous FDA Clearance and CLIA Waiver for Its Sofia(R) Strep A+ Fluorescent Immunoassay (FIA) via the FDA's New Dual Submission Program

Novus Teams Up With PR Revolution to Execute Go-to-Market Strategy
Novus Acquisition & Development Corp (OTC PINK: NDEV), wholly owned subsidiary Novus Medical Group, Inc., a service provider of the health and wellness savings plan, "Novus MedPlan," is proud to announce that it has retained PR Revolution (www.prrevolution.com) as its public relations and marketing agency of record

The Saint Louis Brewery Announces Exclusive Agreement With Ardagh Group for Schlafly Beer
MUNCIE, IN--(Marketwired - December 16, 2014) - Ardagh Group, a leading producer of glass containers for the food and beverage industries in the United States, announced an exclusive, long-term supply agreement with The Saint Louis Brewery to produce 12 ounce specially-designed glass bottles for its Schlafly Beer. The partnership connects The Saint Louis Brewery with Ardagh Group's Pevely, Mo

ETST, an Emerging Health and Wellness Company, Adds Attorney, Steven Warm, Esq., to the Advisory Board to Assist With Its New Cutting Edge Nutritional Products, Dietary Supplements and All Natural High Grade CBD (Cannabidiol) Rich Hemp Oil Products
BOCA RATON, FL--(Marketwired - December 16, 2014) - Earth Science Tech, Inc. (OTCQB: ETST) ("ETST" or "the Company"), a unique biotechnology company focused on nutraceuticals, bioceuticals and dietary supplements, today announced the addition of Steven Warm, Esq. to its advisory board.

Novartis gains FDA approval for Signifor® LAR to treat patients with acromegaly, a rare and life-threatening hormonal disorder
Novartis International AG /Novartis gains FDA approval for Signifor® LAR to treat patients with acromegaly, a rare and life-threatening hormonal disorder . Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

Folic Acid Plays Vital Role in Babies' Health
(Family Features) Each year, more than four million women in America give birth and 2,600 infants are born with neural tube defects. While there are simple preventative steps women can take, Americans are generally unaware of the impact that diet, specifically enriched grains, has on pregnancy and infant health.

UPCOMING DEADLINE: Levi & Korsinsky, LLP Reminds Investors of Class Action Against Unilife Corporation and Its Board of Directors and a Lead Plaintiff Deadline of December 31, 2013 -- UNIS
Levi & Korsinsky announces that a class action lawsuit has been commenced in the United States District Court for the Middle District of Pennsylvania on behalf of investors who purchased Unilife Corporation ("Unilife" or the "Company") (NASDAQ: UNIS) common stock between July 13, 2011 and September 9, 2013.

Quidel Receives FDA Clearance for Its Hand-Held Molecular Diagnostic Test - AmpliVue(R) Group B Strep Assay
Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its AmpliVue Group B Strep Assay

Heat Biologics Announces Its Phase 1/2 Study of HS-410 in Bladder Cancer Is Open for Enrollment
Heat Biologics, Inc. (NASDAQ: HTBX), a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapies, announced today that its Phase 1/2 Study of HS-410 in bladder cancer patients is open for enrollment. HS-410 is a biologic product candidate designed to activate a T-cell mediated pan-antigen immune response for the treatment of bladder cancer.

Acura Pharmaceuticals Secures $10.0 Million of Debt Financing
Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) entered into a Loan and Security Agreement (the "Loan Agreement") with Oxford Finance LLC, pursuant to which Oxford agreed to make a term loan to the Company in the principal amount of $10.0 million. The loan has a fixed interest rate of 8

Sobi to temporarily withdraw New Drug Application for Orfadin® oral suspension in the US
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today its decision to withdraw the company's New Drug Application for an oral suspension of Orfadin in the US

VICAL INCORPORATED SHAREHOLDER ALERT: Levi & Korsinsky, LLP Reminds Investors of Class Action Against Vical Incorporated and Its Board of Directors and a Lead Plaintiff Deadline of December 31, 2013 -- VICL
Levi & Korsinsky announces that a class action lawsuit has been commenced in the United States District Court for the Southern District of California on behalf of investors who purchased Vical Incorporated ("Vical" or the "Company") (NASDAQ: VICL) common stock between February 8, 2012 and August 12, 2013.

Quincy Bioscience Announces the Kickoff of the Prevagen Blog
MADISON, WI--(Marketwired - December 23, 2013) - Quincy Bioscience, best known as the creators of leading memory supplement Prevagen®, gives more resources and opportunities for consumers to learn tips for better brain health this holiday season. The Wisconsin-based biotech company is thrilled to present the takeoff of the new Prevagen Blog.

Titan Pharmaceuticals Receives Official Minutes From FDA Meeting on Probuphine New Drug Application
Titan Pharmaceuticals, Inc. (OTCBB: TTNP) today announced the receipt of the official minutes (the "Minutes") from a Type C meeting with the U.S

Actelion is granted Marketing Authorisation for Opsumit (macitentan) in Pulmonary Arterial Hypertension (PAH) by the European Commission
Actelion Pharmaceuticals Ltd /Actelion is granted Marketing Authorisation for Opsumit (macitentan) in Pulmonary Arterial Hypertension (PAH) by the European Commission . Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

Tree Nut Consumption Associated With Reduced Total and Cause-Specific Mortality
FRESNO, CA--(Marketwired - December 19, 2013) - In a study published November 20, 2013 in the New England Journal of Medicine[1], researchers looked at the association of nut consumption with total and cause-specific mortality among 76,464 women in the Nurses' Health Study and 42,498 men in the Health Professionals Follow-up Study

Cellceutix Files Orphan Drug Designation Application for Brilacidin for Oral Mucositis With US FDA
Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, announces today that it has filed an application with the U.S

USDM Life Sciences Hires FDA's Unique Device Identification Architect, Jay Crowley as Vice President of UDI Practice
USDM Life Sciences, a leading global regulatory consulting firm in the life sciences industry, hires Jay Crowley as Vice President of the Unique Device Identification (UDI) practice.

FluoroPharma Medical Announces Acceptance of Abstract for Oral Presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Winter Meeting
MONTCLAIR, NJ--(Marketwired - December 19, 2013) - FluoroPharma Medical, Inc

NewLink Genetics Launches Phase 1 Clinical Trial of Its HyperAcute(TM) Renal Immunotherapy in Patients With Metastatic Renal Cell Cancer
NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that it had launched a first in human Phase 1 clinical trial of HyperAcute Renal immunotherapy in patients with metastatic renal cell cancer

ANORO(TM) ELLIPTA(TM) Approved as First Once-Daily Dual Bronchodilator for the Treatment of COPD in the US
GlaxoSmithKline plc (LSE: GSK) (NYSE: GSK) and Theravance, Inc

MorphoSys Strengthens Clinical Development Organization with Three Management Appointments
MorphoSys AG /MorphoSys Strengthens Clinical Development Organization with Three Management Appointments . Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

GS1 Named an Accredited Issuing Agency for Unique Device Identifiers by the U.S. Food and Drug Administration
LAWRENCEVILLE, NJ--(Marketwired - December 17, 2013) - GS1, a leading global standards organization, was accredited today by the U.S. Food and Drug Administration (FDA) as an issuing agency for unique device identifiers (UDIs). Global GS1 Standards, administered in the U.S

SHAREHOLER ALERT: Pomerantz Law Firm Has Filed a Class Action Against Unilife Corporation and Certain Officers - UNIS
Pomerantz Grossman Hufford Dahlstrom & Gross LLP has filed a class action lawsuit against Unilife Corporation ("Unilife" or the "Company") (NASDAQ: UNIS) and certain of its officers

Helix BioPharma Corp. Announces Fiscal Q1 2014 Results
Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP), a biopharmaceutical company developing drug candidates for the prevention and treatment of cancer, today announced financial results for the three-month period ended October 31, 2013.

Tree Nut Consumption Associated with Reduced Total and Cause-Specific Mortality
In a study published November 20, 2013 in the New England Journal of Medicine1, researchers looked at the association of nut consumption with total and cause-specific mortality among 76,464 women in the Nurses’ Health Study and 42,498 men in the Health Professionals Follow-up Study

Cellceutix CEO Discusses Corporate Developments in 2012 and Plans for 2013
Cellceutix Corporation (OTCBB: CTIX) (the "Company"), a clinical stage biopharmaceutical company focused on discovering small molecule drugs to treat unmet medical conditions, including drug-resistant cancers and autoimmune diseases, today provides a letter from the CEO regarding developments of the Company throughout 2012 and expectations for 2013.

Tonix Pharmaceuticals Completes $1 Million Financing With Technology Partners
Tonix Pharmaceuticals Holding Corp. (OTCQB: TNXP) ("TONIX" or the "Company"), a specialty pharmaceutical company developing novel treatments for challenging disorders of the central nervous system ("CNS") including fibromyalgia ("FM") and post-traumatic stress disorder ("PTSD"), has raised $1

Hansen Medical to Present at the 31st Annual J.P. Morgan Healthcare Conference
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced that President and CEO Bruce Barclay is scheduled to present at the 31st Annual J.P. Morgan Healthcare Conference. The conference is being held January 7-10, 2013 at the Westin St. Francis Hotel in San Francisco, California

MDMA Leader Mark Leahey to Speak at SEMDA 2013 Conference
Mark B. Leahey, President and CEO for the Medical Device Manufacturers Association (MDMA), will speak at the SEMDA 2013 Conference. MDMA is a national trade association in Washington, DC, that represents hundreds of research-driven medical technology companies.

Acura Pharmaceuticals, Inc. Submits Investigational New Drug Application
Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) today announced that an Investigational New Drug application ("IND") has been filed with the U.S. Food and Drug Administration (FDA) to allow clinical testing of Acura's hydrocodone bitartrate with acetaminophen formulated with Aversion® Technology

The Medicines Company Announces Positive Trial Results for Oritavancin in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
The Medicines Company (NASDAQ: MDCO) today announced results for its SOLO-1 Phase 3 clinical trial of oritavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

Boston Therapeutics Approved in France to Initiate a Clinical Trial With SUGARDOWN(R) in Patients With Type II Diabetes
Boston Therapeutics, Inc

Cytokinetics, Incorporated Announces Listing Transfer from NASDAQ Global Market to NASDAQ Capital Market
South San Francisco, CA - December 18, 2012 - Cytokinetics, Incorporated (NASDAQ: CYTK), announced today that NASDAQ has approved the Company's request to voluntarily transfer the listing of its shares of common stock from The NASDAQ Global Market to The NASDAQ Capital Market

Near Term Catalyst Has ArQule Poised for a Move Up
ArQule, Inc. engages in the research and development of cancer therapeutics directed toward molecular targets and biological processes.

ArQule (ARQL) Poised For A Quick Move Up On Near Term Catalyst
By Scott Matusow, Contributor@scottmatusow

U.S. Food and Drug Administration Approves Remote Monitoring for Drug Trial
AMC Health announced today that it will provide a broad array of telemonitoring services for an innovative clinical trial that has just been cleared by the U.S. Food and Drug Administration (FDA). AMC Health's telemonitoring technologies will dramatically reduce the cost of this study.

GSK and Theravance Announce Regulatory Submission for UMEC/VI (LAMA/LABA) in the US
GlaxoSmithKline plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the submission of a regulatory application in the US for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD).

A Strong Speculative BioPharma Poised For A Quick Move Up On Near Term Catalyst
By Scott Matusow, Contributor@scottmatusow

How to Love Your Heart
(Family Features) It beats about 100,000 times a day, 35 million times a year. It pumps blood through the body three times every minute, taking that blood on the equivalent of a 12,000 mile trek every 24 hours. Even at rest, it works twice as hard as the leg muscles of a person running. The heart is a remarkable, vital muscle that warrants great care and maintenance

Titan Pharmaceuticals Licenses Exclusive Probuphine(R) Commercialization Rights in U.S. and Canada to Braeburn Pharmaceuticals
Titan Pharmaceuticals, Inc. (OTCBB: TTNP) today announced the signing of a license agreement with Braeburn Pharmaceuticals Sprl, wholly owned by Apple Tree Partners IV, L.P., a partnership affiliated with Apple Tree Partners

Novartis drug Signifor® gains FDA approval as the first medication to treat Cushing's disease, a serious endocrine disorder
Novartis International AG /Novartis drug Signifor® gains FDA approval as the first medication to treat Cushing's disease, a serious endocrine disorder . Processed and transmitted by Thomson Reuters ONE.The issuer is solely responsible for the content of this announcement.

SmartTots Releases Consensus Statement Regarding Anesthesia Safety in Children
SmartTots released a consensus statementtoday regarding the safety of anesthetics and sedative agents administeredto infants and young children

Company Financed by Noble Financial Capital Markets -- MobileHelp(R) -- First to Register Mobile Medical Alert Device With FDA
MobileHelp®, a company that Noble Financial Capital Markets (Noble) has been engaged as its investment banker for more than three years, and has assisted in three rounds of financing, announced today that it has been officially included in the U.S. Food and Drug Administration's (FDA) list of registered medical device companies

ELIQUIS® (apixaban) Approved In Japan For The Prevention Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation
Bristol-Myers Squibb (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved ELIQUIS® (apixaban) for the prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF)

Covidien Announces Definitive Agreement to Acquire CV Ingenuity
Covidien (NYSE: COV), a leading global provider of healthcare products, has announced a definitive agreement to acquire CV Ingenuity. The companies expect to complete the acquisition in the first calendar quarter of 2013. Financial terms of the transaction were not disclosed.

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