Le Lézard

Communiqués de presse par sujet : Approbation de la FDA (Food and Drug Administration)

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31 juillet 2017

15:20
Kitov Pharmaceuticals Holdings Ltd. , an innovative biopharmaceutical company, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for KIT-302, its lead drug candidate. KIT-302 is a...

12:07
Bunge North America, the North American arm of Bunge Limited , is pleased to announce that the U.S. Food and Drug Administration (FDA) approved its petition for a qualified health claim linking consumption of soybean oil to reduced risk of coronary...

09:00
Amgen and Allergan plc. today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 980, a biosimilar candidate to Herceptin® (trastuzumab). Amgen and Allergan are collaborating on...

07:30
Accuray Incorporated announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its iDMStm Data Management System, enabling its use with the Company's TomoTherapy® platform. It's designed to integrate with...

07:00
Bruker today announces that it has received US Food & Drug Administration (FDA) clearance for its third, further expanded claim for the market-leading MALDI Biotyper-CA (MBT-CA) system for fast, accurate and cost-effective microbial identification....

07:00
Immunalysis Corporation, a division of Alere Inc. , today announced that its SEFRIAtm Fentanyl Urine Enzyme Immunoassay has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for the qualitative detection of fentanyl in...


28 juillet 2017

09:00
Under the Orphan Drug Act (ODA), drugs, vaccines, and diagnostic agents qualify for orphan status if they are intended to treat a disease affecting less than 200,000 American citizens. Orphan drug sponsors qualify for seven-year FDA-administered...

08:00
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced the U.S. Food and Drug Administration (FDA) approved VARIBAR NECTAR (barium sulfate) oral suspension...


27 juillet 2017

17:49
Amgen  today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Amgen's supplemental Biologics License Application (sBLA) for Repatha® (evolocumab), a PCSK9 inhibitor. If approved by the FDA, the U.S....

11:28
Quantitative Insights, Inc. (QI) today announced that it has received regulatory clearance (via De Novo classification) from the U.S. Food and Drug Administration (FDA) for its QuantXtm Advanced system, the industry's first computer-aided diagnosis...

10:00
The XERO Viewer is part of Agfa HealthCare's award-winning Enterprise Imaging platform, which consolidates imaging data from multiple service lines and provides secure access to a patient's medical images, in one view, accessible 'anywhere, anytime'....

09:10
Acella Pharmaceuticals, LLC, a leading U.S. developer of specialty pharmaceuticals across several therapeutic categories, recently announced the Food and Drug Administration's approval of the Company's abbreviated new drug application (ANDA) for a...

08:00
Trovagene, Inc. , a precision medicine biotechnology company, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) Application for PCM-075, a Polo-like Kinase 1 (PLK1) inhibitor, and has...

08:00
Eiger BioPharmaceuticals, Inc. , focused on the development and commercialization of targeted therapies for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for pegylated interferon...

03:00
AMO Pharma Limited ("AMO Pharma"), a privately held biopharmaceutical company focusing on debilitating diseases with limited or no treatment options, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation...


26 juillet 2017

18:40
Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for FYCOMPA® (perampanel) CIII as monotherapy use for the treatment of partial-onset seizures (POS) with...

08:05
Sequoia Sciences a annoncé avoir obtenu la désignation Fast Track de la part de la Food and Drug Administration (FDA) américaine, pour son vaccin expérimental novateur destiné au traitement des infections des voies urinaires (IVU) récurrentes causées...

07:00
Algatech (Algatechnologies) Ltd. Received Brazilian Health Regulatory Agency (Anvisa) approval for its all-natural astaxanthin AstaPure® to be used as a food ingredient. Approval was granted thanks to the high quality and purity of this powerful...


25 juillet 2017

11:56
Hologenix, LLC, fabricant de Celliant, la technologie textile sensible la plus avancée au monde et testée...

10:49
ChiRhoClin, Inc. is pleased to notify the medical community that ChiRhoStim® (Human Secretin for Injection) has received FDA approval, updating its package insert. There are two significant changes to the package insert.  The first change eliminates...

10:26
Vertera Spine, a developer of medical devices using advanced biomaterial technologies, today announced the COALESCEtm Lumbar Interbody Fusion Device has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in anterior,...

10:09
Hologenix, LLC, fabricant de Celliant, la technologie textile sensible la plus avancée au monde et...

09:00
Resverlogix Corp. ("Resverlogix" or the "Company") is pleased to announce the receipt of a positive Type C written response from the Division of Metabolism and Endocrinology Products of the U.S. Food and Drug Administration (FDA). In light of...

08:00
Global biotherapeutics leader CSL Behring announced today that HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) is now available in the United States. The U.S. Food and Drug Administration (FDA) approved HAEGARDA on June 22, 2017 for routine...

07:12
AzarGen Biotechnologies (Pty) Ltd (Stellenbosch, South Africa), announced that it has received grant status for the patent application: PRODUCTION OF HUMAN PULMONARY SURFACTANT PROTEIN-B IN PLANTS (EP3013963) from the European Patent Office.     ...

00:00
Hologenix, LLC, maker of Celliant, the world's most advanced, clinically tested responsive textile technology, announced today that the U.S. Food and Drug Administration (FDA) has determined Celliant products are medical devices and general wellness...


24 juillet 2017

08:30
Luminex Corporation today announced that it has received FDA clearance for the ARIES® C. difficile Assay, a moderate complexity, sample to answer test for rapid detection of C. difficile. The ARIES® C. difficile Assay detects both toxin A and toxin...

08:00
ChineseInvestors.com, Inc. ("CIIX" or the "Company"), the premier financial information website for Chinese-speaking investors, today announces that its wholly-owned foreign enterprise, CBD Biotechnology Co. Ltd., has officially filed a record of...


21 juillet 2017

15:18
GSK announced today that the US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Benlysta (belimumab) for the treatment of adult patients with active, autoantibody-positive SLE who are receiving standard therapy....

09:54
Global biotherapeutics leader CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted the Company seven years of orphan-drug exclusivity for HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]), the first and only...

08:00
Teligent, Inc. , a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) of Erythromycin Topical...

07:50
Not intended for UK-based media    If approved, avelumab could be the first immunotherapy treatment indicated for this rare and aggressive skin cancer in the EU    Decision by the EC is expected in the third quarter of 2017 Merck KGaA,...


20 juillet 2017

16:38
Novartis today announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for AMG 334 (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per...

16:30
Amgen  today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Aimovigtm (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per...

14:14
Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU). "Although we can use...

03:00
LEO Pharma today announced that the European Commission has granted marketing authorisation for Kyntheum® (brodalumab), a new biologic for the treatment of moderate-to-severe plaque psoriasis in adults within the European Union who are candidates for...


19 juillet 2017

10:30
BIOTRONIK today announced FDA approval and availability of the Intica DX and Intica cardiac resynchronization therapy (CRT)-DX implantable cardioverter defibrillator (ICD) systems. The launch of Intica CRT-DX extends the proven benefits of...

09:30
Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's supplemental Biologics License Application (BLA) for Hizentra® [Immune globulin subcutaneous (Human) 20%...

08:57
Perrigo Company plc today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing DermOtic® Oil, 0.01% Ear Drops (fluocinolone acetonide oil 0.01%). The...

06:59
BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BD FACSLyrictm flow cytometer system, an easy-to-use in...


18 juillet 2017

16:28
Reha Technology USA Inc. is pleased to announce that starting from June 2017, it offers an FDA approved integrated Functional Electronic Stimulation (FES) for their G-EO System Evolution robotic gait trainer.   Matthew...

14:08
The U.S. Food and Drug Administration today approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two...

08:30
B·R·A·H·M·S GmbH, a part of Thermo Fisher Scientific Inc., today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded use of the B·R·A·H·M·S PCT sensitive KRYPTOR assay. The assay helps hospital...

08:00
Capricor Therapeutics, Inc. , a biotechnology company developing biological therapies for Duchenne muscular dystrophy and other rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease...

07:00
Mallinckrodt plc , a leading global specialty pharmaceutical company, today announced that StrataGraft® regenerative skin tissue is among the first products to be designated as a Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug...


17 juillet 2017

17:44
The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of...

14:06
CSA Medical announced on Monday, an advancement of its catheter technology with the expansion of its truFreeze® catheter offerings to include a third Spray Kit for the truFreeze System, referred to as the Rapid AV Spray Kit. The Rapid AV catheter has...

09:07
Perrigo Company plc today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing AbbVie Inc.'s Androgel® Topical Gel, 1.62% packets (20.25 mg/1.25 g packet...

07:30
Impax Laboratories, Inc. , a specialty pharmaceutical company, today announced it has received an AB therapeutic equivalent rating and final U.S. Food and Drug Administration ("FDA") approval on its Abbreviated New Drug Application ("ANDA") for a...


14 juillet 2017

06:53
Lannett Company, Inc. today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution, USP)...

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