Le Lézard

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

1 décembre 2016

07:05
Biostage, Inc. , ("Biostage" or the "Company"), a biotechnology company developing bioengineered organ implants to treat cancers and other life-threatening conditions of the esophagus, bronchus and trachea, today announced that its Cellspantm...

03:00
Helsinn Integrative Care, Helsinn's business unit focused on evidence-based, non-pharmaceutical cancer supportive care products, today announces that Xonrid® Gel, a topical gel for radiotherapy-induced dermatitis, already classified as a medical...


30 novembre 2016

14:00
 - Orphan Drug Designation program provides orphan status to medications intended for the safe and effective treatment, diagnosis or prevention of rare diseases[1] - Risankizumab is an investigational treatment being evaluated in immunological...

09:25
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 Clobetasol Propionate...

08:30
CellResearch Corporation Pte Ltd ("CellResearch"), a Singapore-based company that specializes in stem cell technology, through its wholly owned subsidiary, CordLabs Pte Ltd ("CordLabs"), has entered into an agreement with CariCord Inc. ("CariCord")...


29 novembre 2016

14:32
Rodo Medical, Inc., an innovative dental device company, announces FDA clearance of the Rodo Abutment System, featuring the shape-memory Smileloc® retentive sleeve. The Rodo Abutment System radically simplifies the process for placing and retrieving...

08:21
Not intended for UK-based media If approved by the FDA, avelumab, an investigational immunotherapy, could be the first treatment indicated for patients with metastatic Merkel cell carcinoma (MCC)  Avelumab has previously received FDA Breakthrough...

08:00
Vtesse, Inc., a company committed to developing medicines to benefit patients with ultra rare, life-threatening diseases, announced today that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease designation to VTS-270, the...


28 novembre 2016

15:45
Breckenridge Pharmaceutical, Inc. announced today that it has launched its ANDA for Armodafinil tablets (CIV) in 50mg, 150mg and 250mg strengths on November 28, 2016, after having received final approval by FDA.  Armodafinil tablets is a generic...

10:00
Global Health Solutions has announced 510k FDA approval of PolyPlex Wound Dressing, a first of its kind, petrolatum based topical gel indicated for acute and chronic wound management. PolyPlex Wound Dressing employs Global Health Solutions'...

09:00
Nature Cell Co., Ltd. (Nature Cell) (CEO, Dr. Jeongchan Ra), a leading biotechnology company, announces AstroStem's approval for Phase I and Phase II clinical trials for treatment of Alzheimer's disease by the U.S. Food and Drug Administration (FDA)...

08:30
PhaseRx, Inc. , a biopharmaceutical company developing mRNA treatments for life-threatening inherited liver diseases in children, today announced that its lead candidate, PRX-OTC, which is being developed for the treatment of ornithine...

08:08
BiondVax Pharmaceuticals Ltd. , a clinical stage biopharmaceutical company focused on developing and commercializing a vaccine against current and future seasonal and pandemic influenza strains, today announced its third quarter 2016 financial...

06:54
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 Metaxalone Tablets USP, 800 mg, the therapeutic equivalent to the reference listed...


25 novembre 2016

14:43
DILON Diagnostics and GE Healthcare are pleased to announce the FDA clearance of the Molecular Breast Imaging (MBI) localization accessory for breast biopsy. The Discovery NM750b and the breast biopsy accessory will be presented at the RSNA...


22 novembre 2016

16:39
Millions of glaucoma patients whose previous surgical treatment failed to reduce their eye pressure have new hope following several years of pivotal clinical trials conducted in refractory glaucoma patients, including work done at the University of...

11:07
Lipogems, a leading international tissue repair company, today announced the U.S. Food and Drug Administration 510(k) clearance for expanded indications and labeling of The Lipogems® System for adipose tissue transfer.   Lipogems' historical...

07:35
Allergan plc announced today the U.S. Food and Drug Administration (FDA) has cleared the XEN® Glaucoma Treatment System (consisting of the XEN45 Gel Stent and the XEN Injector) for use in the U.S. The XEN Glaucoma Treatment System reduces...

07:00
A new clinical study confirms positive effects of BCM-95®, a high-potency turmeric extract in treating Major Depressive Disorder (MDD) and anxiety.      (Photo: http://photos.prnewswire.com/prnh/20161122/441993-INFO ) The randomized, double-blind,...

07:00
The first cases of highly pathogenic H5N6 Avian Influenza ("Bird Flu") were confirmed last week in South Korea[1]. Over 62,000 birds have been culled in an effort to prevent the spread. H5N6 first emerged in 2014 and has since been found in China,...


21 novembre 2016

19:51
Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application for Xultophy® 100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6 mg/mL injection). Xultophy®...

19:19
Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved once-daily Soliquatm 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL for the treatment of adults with type 2 diabetes inadequately controlled...

16:37
Janssen Biotech, Inc. announced today the U.S. Food and Drug Administration (FDA) has approved DARZALEX® (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple...

10:30
International Isotopes Inc. (the "Company") announces that it has submitted an abbreviated new drug application (aNDA) to the U.S. Food and Drug Administration (FDA) for its I3odine/MAXtm sodium iodide radiopharmaceutical product.  This is the first...

09:00
Equashield, a leading provider of Closed System Transfer Devices (CSTD) for safe and simple handling of hazardous drugs, announced today that it is expanding its range of solutions and products offered by entering the field of automation. Its newest...

09:00
Oxitec announced today the Board of the Florida Keys Mosquito Control District (FKMCD) voted to approve the investigational agreement for use of self-limiting Friendlytm mosquitoes in an effectiveness trial to fight against Aedes aegypti, the primary...

08:30
Ascensia Diabetes Care announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the CONTOUR® NEXT ONE Blood Glucose Monitoring System (BGMS), marking a key step in making the next-generation system available to people...

08:28
GSK [LSE/NYSE: GSK] announced today it has received approval from the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research expanding the indication for FluLaval® Quadrivalent (Influenza Vaccine) to include use in...

06:30
GlaxoSmithKline Inc. (GSK) has submitted a New Drug Submission (NDS) for its candidate shingles vaccine, seeking approval for the prevention of herpes zoster (shingles) and its complications in Canadians aged 50 years or over. Dr. Emmanuel Hanon,...

06:30
GlaxoSmithKline Inc. (GSK) a déposé une présentation de drogue nouvelle pour son vaccin expérimental contre le zona afin de le faire approuver pour la prévention du zona et de ses complications chez les Canadiens de 50 ans et plus. « Le zona est une...


17 novembre 2016

09:34
The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first...

08:00
Janssen Biotech, Inc. (Janssen) announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of guselkumab for the treatment of adults living with moderate to severe plaque...


16 novembre 2016

08:06
Amplyx Pharmaceuticals, a company developing novel antifungal agents for life-threatening fungal infections, announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Product Development has granted orphan drug designation to...

07:00
The National Advisory Committee on Immunization (NACI) concludes that there is good evidence to recommend, on an individual basis, the Prevnar® 13 vaccine followed by Pneumovax® 23 for immunocompetent adults aged 65 years and older not previously...

07:00
Le Comité consultatif national de l'immunisation (CCNI) conclut qu'il existe des données probantes suffisantes pour recommander, au cas par cas, c.-à-d. sur une base individuelle, l'utilisation de PrevnarMD 13 suivi de PneumovaxMD 23 chez les adultes...

06:00
Inova Diagnostics, a worldwide leader in autoimmune diagnostic reagents and systems for the clinical laboratory, is pleased to announce the US Food and Drug Administration (FDA) clearance of QUANTA Lite Calprotectin Extended Range, an assay which...


14 novembre 2016

08:00
Boston Biomedical, an industry leader in the development of novel compounds designed to target cancer stemness pathways, announced that its lead investigational compound, napabucasin, has received Orphan Drug Designation from the U.S. Food and Drug...

08:00
Pharming Group N.V. (the "Company") (EURONEXT: PHARM) today announced that the results of its "Randomized, Double-Blind, Placebo-Controlled Trial of Recombinant Human C1 Inhibitor for Prophylaxis of Hereditary Angioedema Attacks", were presented by...

07:00
ARMO BioSciences, Inc., a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has granted the Company's lead investigational immuno-oncology drug AM0010 (PEGylated Interleukin-10) Orphan Drug designation...

06:56
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 Memantine Hydrochloride Tablets USP, 5 mg and 10 mg, the therapeutic equivalent to...


10 novembre 2016

14:09
Statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids The United States is tied for last in the world in the size of warning labels required on cigarette packs, according to a new international report issued today by the Canadian...


8 novembre 2016

11:13
MedReleaf, Canada's leading medical cannabis licensed producer, today announced it has become the first licensed producer (LP) to bring cannabis capsules to market. This news follows on recent Health Canada approval for MedReleaf to begin selling...

09:00
Syneron Medical Ltd. , a leading global aesthetic device company, announced today that it has achieved two major milestones to further strengthen Profound's position in the marketplace. Profoundtm is a minimally invasive, fractional radiofrequency...

08:30
KATOR, a start-up medical device company focused on advanced tissue-to-bone reattachment systems, announces that it has received its second FDA 510(k) clearance for its innovative KATOR Suture Anchor System.   Logo -...

07:35
Mallinckrodt Pharmaceuticals , a leading global specialty pharmaceutical company, announced today the U.S. Food and Drug Administration (FDA) has approved a Prior Approval Supplement for OFIRMEV® (acetaminophen) injection available in an intravenous...

04:00
Eloxx Pharmaceuticals, a biotechnology company focused on discovery, development and commercialization of compounds for the treatment of genetic diseases caused by nonsense mutations, announced today that the U.S. Food and Drug Administration (FDA)...

04:00
Eloxx Pharmaceuticals, une société de biotechnologie axée sur la découverte, le développement et la commercialisation de composés pour le traitement des maladies génétiques provoquées par des mutations non-sens, a annoncé aujourd'hui que la Food and...


7 novembre 2016

10:00
Roche (SIX: RO, ROG; OTCQX:RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved  the VENTANA ALK (D5F3) CDx Assay1 for use on the VENTANA BenchMark ULTRA automated slide stainer. The assay is a companion diagnostic to...

06:00
Propeller Health, the leading digital solution for respiratory medicine, today announced U.S. Food and Drug Administration 510(k) clearance to market its Propeller platform for use with GSK's Ellipta® inhaler, the pharmaceutical company's innovative,...


4 novembre 2016

17:26
Amgen  today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expanded use of ENBREL® (etanercept), making it the first and only systemic therapy to treat pediatric...