Le Lézard

News by subject: FDA

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2 july 2015

09:00
Vanda Pharmaceuticals Inc. (Vanda) today announced that a HETLIOZ® patent, number 9,060,995 ('995 patent), is now listed in the U.S. Food and Drug Administration publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly...


1 july 2015

10:00
Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved the use of transvaginal ultrasound (TVU) as an alternate confirmation test for Essure® permanent birth control. A confirmation test must be given three...

08:17
MX Orthopedics, Corp. (MXO), a leader in superelastic technologies for orthopedic implants, announces the recent FDA clearance (K143622) of its patent-pending dynaMXtm Compression Staple featuring Malleable Nitinol Technology.  MX Orthopedics, Corp....

06:50
Accutest Laboratories recently completed a first-to-file study for the fixed dose combination of Memantine 28 mg ER and Donepezil hydrochloride 10 mg capsule in a record setting time of 5 days. This included volunteer screening, clinical, analytical,...


30 june 2015

16:10
IGI Laboratories, Inc. , a New Jersey based specialty generic pharmaceutical company, today announced it has submitted its fifth abbreviated new drug application (ANDA) to the U.S. Food and Drug Administration (FDA) of 2015, which brings the...

11:59
Aridis Pharmaceuticals, Inc., a biopharmaceutical company applying proprietary technologies to produce novel therapies for infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to its...

10:11
BioLight Life Sciences Investments Ltd. , a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announced today that its CellDetect® non-invasive test for detecting bladder cancer in urine...

09:18
Oramed Pharmaceuticals Inc. (http://www.oramed.com), a clinical-stage pharmaceutical Company focused on the development of oral drug delivery systems, announced today that the first patient has been screened in the Company's Phase IIb trial of its...

08:00
Centinel Spine, Inc., (Centinel Spine) the pioneer of Stand-Alone, No-Profile®, Integrated Interbody fusion devices was granted the first cervical multilevel indication for a Stand-Alone interbody device by the U.S. Food and Drug Administration...

07:00
Telesta Therapeutics Inc. (PNK: BNHLF) announced today that it has submitted electronically, through its U.S. agent, a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for...


29 june 2015

08:00
The automotive industry has long been introducing new and innovative features to cars on the basis of consumer trends, preferences, safety bulletins and market positioning. The industry is now on the verge of integrating health, wellness and...

08:00
The automotive industry has long been introducing new and innovative features to cars on the basis of consumer trends, preferences, safety bulletins and market positioning. The industry is now on the verge of integrating health, wellness and...

01:32
Stockton-Agrimor Philippines, Inc. a member of the Stockton Group (STK), announced today that the Philippine's Bureau of Agriculture and Fisheries Standards has approved the full registration of Timorex Gold® use in Black Sigatoka disease. Growers...


25 june 2015

10:00
Opsens Inc. ("Opsens" or the "Company") announces that in light of the positive feedback on the performance of its products developed to measure Fractional Flow Reserve ("FFR"), the OptoWire and OptoMonitor ("Opsens' FFR products"), and the recent...

07:00
Syneron Medical Ltd. , a global market leader in the aesthetic medical device marketplace, today released the  results of a new clinical trial for Profoundtm, an innovative radiofrequency device clinically proven to improve facial and neck wrinkles...

07:00
Merrimack Pharmaceuticals, Inc. and Baxalta Incorporated, a wholly-owned subsidiary of Baxter International Inc , today jointly announced that the New Drug Application (NDA) for MM-398 (irinotecan liposome injection), also known as "nal-IRI," has...

03:00
Press release not intended for US and UK media EU approval paves the way for LIXIANA® (edoxaban) to be made available across all European member states   Marketing authorisation is based on data from the ENGAGE AF-TIMI 48 and Hokusai-VTE studies,...


24 june 2015

16:12
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced today its role in the successful Premarket Approval (PMA) application decision by the U.S. Food and Drug Administration (FDA) to approve VertiFlex Inc.'s Superion® Interspinous Spacer...

16:01
Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announced today that the U.S. Food and Drug Administration (FDA) has approved the Cochleartm Nucleus® 6 Sound Processor for use with the Nucleus 22 Cochlear Implant,...

13:24
BRAEBON Medical Corporation announces today that the DentiTrac® oral appliance compliance system has passed a substantial regulatory hurdle and is now FDA cleared in the USA for use with the SomnoDent oral device.  BRAEBON congratulates SomnoMed for...

12:08
TissueGene, Inc. today reported that the U.S. Food and Drug Administration (FDA) accepted the proposed brand name Invossa for TissueGene-C, the Company's proprietary product in development for treatment of osteoarthritis of the knee. FDA's acceptance...

07:30
Nuvo Research Inc. , a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today provided an update on its international licensing initiatives for Pennsaid 2%. Regulatory Approval to Conduct Phase 3...


23 june 2015

12:15
MedNet Solutions, an innovative SaaS-based eClinical technology company that supports the entire spectrum of clinical research, is pleased to announce that iMedNettm, the company's intuitive, flexible and affordable cloud-based eClinical technology...

11:15
The Suffolk County Department of Health Services Bureau of Public Health Protection has contracted Decade Software Company, LLC's environmental health software EnvisionConnect, the company announced today. The County will use EnvisionConnect and...

09:15
Valeant Pharmaceuticals International, Inc.   and Progenics Pharmaceuticals, Inc. today announced that Valeant submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for RELISTOR® (methylnaltrexone bromide) Tablets for the...


22 june 2015

15:00
-- One-year outcomes from the GARFIELD-AF Registry show poor VKA control and high risk scores increased mortality and strokes in newly diagnosed atrial fibrillation (AF) patients --  Real-life data from nearly 17,200 patients enrolled in the Global...

08:20
Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 5mg/ 5ml of Oxycodone HCl liquid which is used in treatment of moderate to severe acute and chronic...

08:04
Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved FYCOMPA® (perampanel) CIII for adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures, one of the most common and severe forms...

07:00
Vaxil Bio, a company specializing in the development of immunotherapy-based drugs, reports today that its lead product, ImMucin, has been granted an "orphan drug" designation by the US Food and Drug Administration (FDA), for the treatment of...


18 june 2015

08:00
Daiichi Sankyo announces the initiation of Hokusai-VTE Cancer, a multinational study investigating edoxaban in venous thromboembolism (VTE) associated with cancer  Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the...


17 june 2015

19:07
Edwards Lifesciences Corporation , the global leader in the science of heart valves and hemodynamic monitoring, today announced U.S. Food and Drug Administration (FDA) approval of its most advanced transcatheter aortic heart valve ? the Edwards...

08:30
BiondVax Pharmaceuticals Ltd. , a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today announced that its Investigational New Drug Application (IND) for its...

06:42
Centinel Spinetm, Inc., (Centinel Spine) the pioneer of Stand-Alone, No-Profile®, Integrated Interbodytm fusion devices receive FDA clearance for its STALIF MIDLINE®, MIDLINE IItm, MIDLINE II-Titm (Ti-ACTIVEtm) devices for use with allogeneic bone...

03:00
The European Commission grants marketing authorization for GARDASIL 9, the only 9-valent HPV vaccine  Sanofi Pasteur MSD announced today that the European Commission has granted marketing authorization for GARDASIL 9. GARDASIL 9 is a 9-valent HPV...


16 june 2015

08:30
Cerapedics, a privately-held orthobiologics company, announced today that the U.S. Food and Drug Administration has informed the company that an advisory committee panel meeting will not be required for the final review of the Premarket Approval...

08:15
Oramed Pharmaceuticals Inc. (http://www.oramed.com), a developer of oral drug delivery systems, announced today that the Russian Federal Service for Intellectual Property has granted the Company a patent for its invention, titled "Methods and...

08:00
Impax Specialty Pharma, a division of Impax Laboratories, Inc. , announced today that the U.S. Food and Drug Administration (FDA) has approved ZOMIG Nasal Spray for use in pediatric patients 12 years of age and older for the acute treatment of...

02:00
Gedeon Richter Plc and Allergan Plc today announced that the U.S. Food and Drug Administration (FDA) notified the companies that it will require a three-month extension to complete its review of data supporting the resubmission of the New Drug...


15 june 2015

12:09
Chiasma, Inc., a U.S. privately held biopharma company, today announced the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of octreotide capsules, an...

11:38
Opsens Inc. ("Opsens" or the "Company") today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the OptoWire and OptoMonitor, its products developed to measure Fractional Flow Reserve ("FFR"). This measure is used to...

11:09
The FDA authorized the marketing of the Scrambler Therapy® Technology MC-5A device. This medical device has been developed in Italy for the treatment of chronic neuropathic and oncologic pain resistant to opiates and other types of treatment,...

09:00
BiondVax Pharmaceuticals Ltd. , a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today announced that it has been invited to present in a workshop organized by...

08:03
Breathe Technologies, Inc., a developer and manufacturer of medical technologies for patients with respiratory insufficiency and neuromuscular diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for...

08:00
Nutrinia, developing therapies to treat rare gastrointestinal disorders, announced today that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for the company's orally-administered drug for treating short bowel syndrome...

07:00
Ventana Medical Systems, Inc.  (Ventana), a member of the Roche Group, today announced approval of the VENTANA ALK (D5F3) CDx Assay by the US Food and Drug Administration (FDA) as a companion diagnostic to aid in the identification of patients for...


12 june 2015

12:15
Partnership program with Proteus S.A. (Chile) and Boston Children's Hospital (USA)  Grünenthal's Innovative Medicines Unit driving the program in a new approach to research & development   Grünenthal Group, an international, family-owned...


11 june 2015

18:31
Novartis announced today that the US Food and Drug Administration (FDA) has approved Promacta® (eltrombopag) for the treatment of children six years and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to...

02:00
Atlas Genetics Ltd ("Atlas" or the "Company"), the ultra-rapid 'test and treat' molecular diagnostics company, today announces a collaboration with St George's, University of London to develop and evaluate DNA-based point of care tests which can...


10 june 2015

10:30
Sleep Specialists, LLC, a medical device company specializing in sleep therapy, announced today that their FDA cleared Zzoma Positional Device was used in a clinical trial examining the cost effectiveness of incorporating positional therapy into the...

02:00
BerGenBio AS ("BerGenBio" or the "Company"), an oncology biopharmaceutical company, today announces that its multi-centre open label Phase 1b trial (BGBC004) of BGB324, a selective inhibitor of Axl, in patients with Stage IIIb and Stage IV non-small...

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