Le Lézard

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

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

6 mars 2018

09:45
The U.S. Food and Drug Administration today authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants). It is the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast...


5 mars 2018

09:00
Moleac, a biopharmaceutical company focused on research and development of new medicines for central nervous system (CNS) diseases and injuries, today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational new drug...


2 mars 2018

08:30
Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with standard review the company's New Drug Application (NDA) seeking marketing approval for solriamfetol, an investigational medicine...

07:30
Global pharmaceutical company Mylan N.V. today announced that it will launch two new HIV treatments, Symfi Lotm and Cimduotm, which were approved in February by the U.S. Food and Drug Administration (FDA). Mylan anticipates introducing Symfi Lo in...


28 février 2018

08:00
MAIA Pharmaceuticals, Inc., a Princeton, NJ based specialty pharmaceutical company, announces the Tentative Approval of its Sincalide for Injection NDA by the U.S. Food and Drug Administration (FDA). As of 2013, there were over 648,000 patients1...


27 février 2018

23:14
The Center for Craniofacial & Dental Sleep Medicine (CFDSM), a Houston-based company specializing in dental sleep medicine and sleep apnea treatment, announced that it has received FDA clearance on its innovative new treatment for obstructive sleep...

08:00
Johnson & Johnson Medical Devices Companies* today announced that Acclarent, Inc., a leader in developing minimally-invasive Ear, Nose & Throat (ENT) technologies, has received clearance from the U.S. Food and Drug Administration (FDA) to expand the...


26 février 2018

19:04
WuXi Biologics (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, congratulates its partner MabSpace Biosciences for FDA Investigational...

16:16
Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has approved VerzenioTM (abemaciclib) in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for the treatment of postmenopausal women...

09:00
Yisheng Biopharma Co., Ltd. ("Yisheng Biopharma"), a biopharmaceutical company focusing on research, development, manufacturing, sales and marketing of immunological biologics and vaccines, today announced that the U.S. Food and Drug Administration...


25 février 2018

20:00
Alma Lasers, a subsidiary of Sisram Medical Ltd ("Sisram" or the "Company"; stock code: 1696.HK), the leading global innovator of laser light-based, radiofrequency and ultrasound solutions for the aesthetic and surgical markets and the #1 rated...


23 février 2018

06:55
Mallinckrodt plc , a leading global specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA)  seeking approval of its recently acquired developmental product...


22 février 2018

11:30
EMD Serono, Canada, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada, and Pfizer Canada Inc. announced that Health Canada has approved BAVENCIOtm (avelumab for injection) for the treatment of metastatic Merkel...

11:30
EMD Serono Canada (entreprise biopharmaceutique présente aux États-Unis et au Canada, et filiale de Merck KGaA, Darmstadt, Allemagne) et Pfizer Canada inc. annoncent que Santé Canada a approuvé BAVENCIOMC (avélumab pour injection) pour le traitement...

08:30
Access Vascular, a medical device company reinventing venous access using proprietary material technology designed to reduce thrombus accumulation, announced today that the Company has received 510(k) clearance from the U.S. Food and Drug...


20 février 2018

09:01
INVO Bioscience, Inc. , a medical device company granted FDA clearance for the first Intravaginal Culture System, INVOcelltm, today announced that Alabama Fertility, a leading reproductive medicine practice in Birmingham, Alabama, has expanded its...

07:30
Global pharmaceutical company Mylan N.V. today announced receipt of tentative approval from the U.S. Food and Drug Administration (FDA) under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir,...


16 février 2018

23:11
AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has approved IMFINZI® (durvalumab) for the treatment of patients with unresectable Stage III non-small cell...

16:58
The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not...

09:00
Photocure ASA (OSE: PHO), announced today that the U.S. Food and Drug Administration (FDA) approved its supplemental new drug application (sNDA) to extend the indication for Blue Light Cystoscopy (BLCtm) with Cysview® to include Flexible Cystoscopes,...

07:30
Prometic Life Sciences Inc. ("Prometic") today announced the publication...

07:30
Nouvelle voie impliquée dans le développement de la fibrose et l'importance de deux récepteurs agissant à titre de « doubles interrupteurs principaux » Des études effectuées chez des souris déficientes démontrent que le récepteur GPR40 agit de façon...


15 février 2018

13:31
The Food and Drug Administration (FDA) has expanded the indication for Stryker's Trevo Retriever as a front-line treatment for patients experiencing acute ischemic stroke up to 24 hours from symptom onset ? increasing the treatment window by 18...

09:00
Viz.ai, Inc., an applied artificial intelligence healthcare company announced that the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the first-ever Computer-Aided Triage and Notification Platform to identify Large Vessel...

08:44
Désignation supplémentaire de médicament orphelin ajoutée au portefeuille croissant de thérapeutiques uniques dérivées du plasma L'entérocolite nécrosante est la condition gastro-intestinale acquise la plus commune chez les nouveau-nés prématurés et...

08:41
Prometic Life Sciences Inc. (TSX:...

08:07
Arterys Inc., the leader in intelligent, cloud-based medical imaging software solutions, today announced its fifth 510(k) clearance from the U.S. Food and Drug Administration (FDA). The clearance is for the Arterys Oncology AI suite, and is a...


14 février 2018

15:56
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved ERLEADAtm (apalutamide), a next-generation androgen receptor inhibitor,1 for the treatment of patients with...

13:52
The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy...

13:20
The U.S. Food and Drug Administration today permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults. The FDA reviewed and authorized for marketing the Banyan Brain...

07:00
Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. ("Valeant"), today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application for JEMDELtm1 (halobetasol propionate 0.01%) (IDP-122)...


13 février 2018

15:48
Today, the U.S. Food and Drug Administration permitted marketing of the Viz.AI Contact application, a type of clinical decision support software designed to analyze computed tomography (CT) results that may notify providers of a potential stroke in...

14:05
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA clearance for the cobas® Factor II and Factor V Test for use on the cobas® 4800 system. The test enables laboratories to simultaneously assess Factor II and Factor V gene...

06:59
BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced that it has received pre-market approval from the U.S. Food and Drug Administration (FDA) for the BD Onclaritytm HPV assay. The test detects 14 types of...

01:25
Sandoz, a Novartis division, today announced the US FDA approval and launch of Glatopa® (glatiramer acetate injection) 40 mg/mL. Glatopa (glatiramer acetate injection) 40 mg/mL is FDA-approved as a fully-substitutable,...


8 février 2018

14:37
PLENVU® est la première préparation intestinale de 1 litre à base de PEG   PLENVU® est supérieure à MOVIPREP® en termes de nettoyage très approfondi du côlon ascendant, une partie importante pour la détection des adénomes Norgine B.V. a...

11:42
Today, I'm proud to acknowledge the role the FDA played in the groundbreaking effort to develop a new imaging technology ? the RadioGenix System. This new technology was the result of a broad collaboration across the federal government and industry,...

11:20
The U.S. Food and Drug Administration and the Nuclear Regulatory Commission (NRC) today took steps to ensure a stable and secure supply of a critical radioactive imaging product used to detect potentially life-threatening diseases. The FDA approved...

10:59
Pharmaceutics International, Inc. (Pii), a Contract Development Manufacturing Organization (CDMO) based in Hunt Valley, Maryland, together with their partners, received FDA market approval for seven new products and commercially launched six products...

08:00
DarioHealth Corp. , a leading global digital health company with mobile health and big data solutions, today announced it has entered into an agreement with a pharmaceutical company conducting a clinical study for a new drug related to managing...

07:00
Propeller Health, the leading digital solution for respiratory medicine, has been awarded International Organization for Standardization (ISO) 13485:2016 certification for medical device quality management systems. Propeller's FDA-cleared medical...

07:00
PLENVU® is the first 1-litre PEG bowel preparation   PLENVU® is superior to MOVIPREP® in providing high-quality cleansing in the colon ascendens - an important area for adenoma detection  Norgine B.V. today announced that the marketing...

01:22
Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) antagonist approved to treat moderate to severe plaque psoriasis.1 The updated label...


7 février 2018

10:15
Phosplatin Therapeutics LLC, a clinical stage pharmaceutical company focused on oncology drug development, announced today it has enrolled the first cohort of patients into its Phase I / II study of PT-112 as a single agent in relapsed or refractory...

10:00
RESTON, Va., Feb. 07, 2018 /PRNewswire-PRWeb/ -- MMJ International Holdings, the premier medical cannabis research company that is advancing the science of medical marijuana through FDA patient clinical research and the operation of medical cannabis...

08:30
Therapix Biosciences Ltd. ("Therapix" or the "Company"), a specialty clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, announced today that it has held a pre-Investigational New Drug (pre-IND)...

05:00
Mesa Biotech Inc., a privately held, molecular diagnostic company that has developed an affordable PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced that it...


6 février 2018

09:45
Grifols (MCE: GRF, MCE: GRF.P, and NASDAQ: GRFS), a leading global producer of plasma-derived medicines and provider of a variety of postexposure prophylaxis and immune globulin products for patients, has received approval from the U.S. Food & Drug...

09:00
SANDY, Utah., Feb. 6, 2018 /PRNewswire-PRWeb/ --Utah Cord Bank (UCB) is pleased to announce that it has engaged in a consulting agreement with A3Cell and Dr. Barbara Krutchkoff* to help strategize its regulatory roadmap over the coming years. UCB...


5 février 2018

08:40
Today, True Health announced that it is now offering comprehensive testing for celiac disease and gluten sensitivity. When medically necessary, this testing will provide clinicians useful diagnostics to determine the specific cause of symptoms...

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19