Le Lézard

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

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18 septembre 2018

15:13
Today, the U.S. Food and Drug Administration took new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). This new plan includes several measures to...

08:45
Healcerion today announced the SONON 300L will be unveiled to the US market with live demos at booth #722 in the New Exhibitor Pavilion at FMX Family Medicine Experience Show 2018, October 9-13, Ernest N. Morial Convention Center, New Orleans, LA....

08:10
Contego Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the first filter-based Integrated Embolic Protection (IEP) device, the Paladin® Carotid PTA Balloon System. Contego Medical is...

08:05
FDA & USDA announced they have approved Phageguard-E as a "GRAS" (Generally Recognized as Safe) food processing aid against E.coli O157. The new product consists of natural phages against E.coli and is produced by Micreos of The Netherlands. The...

07:00
Bayer Inc. a annoncé que Santé Canada avait approuvé le comprimé pelliculé XARELTO® (rivaroxaban; 2,5 mg), en association à 75 à 100 mg d'acide acétylsalicylique* (AAS), pour la prévention de l'accident vasculaire cérébral, de l'infarctus...

07:00
Bayer Inc. has announced that Health Canada has approved XARELTO® (rivaroxaban) film-coated tablet (2.5 mg), in combination with 75 mg ? 100 mg acetylsalicylic acid (ASA)* for the prevention of stroke, myocardial infarction and cardiovascular death,...


17 septembre 2018

10:35
Oramed Pharmaceuticals Inc. (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New...

09:00
WAT Medical's innovative technology to treat all primary headaches, HeadaTerm, received its FDA clearance in September 2018. This product, already approved by CE, HC, and now FDA, has been distributed in over 20 countries around the world. It has now...

08:01
Sebacia, Inc., a privately held, commercial stage dermatology and aesthetics company, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its lead product, Sebacia Microparticles. This significant achievement is...

08:00
Halozyme Therapeutics, Inc. today announced that Roche has received approval from Health Canada for a subcutaneous (SC) formulation of trastuzumab (Herceptin SC) for the treatment of patients with HER2-positive breast cancer. This is a...


14 septembre 2018

13:26
BIOTRONIK today announced the FDA approval of the PK Papyrus covered coronary stent system under Humanitarian Device Exemption for use in the emergency treatment of acute coronary perforations.1,2 PK Papyrus received CE marking in 2013....

12:45
The U.S. Food and Drug Administration today approved a device intended to treat acute coronary artery perforations, or tears in the blood vessels of the heart. The PK Papyrus Covered Coronary Stent System is the first device approved by the FDA for...


13 septembre 2018

14:18
The U.S. Food and Drug Administration today approved Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior...

10:00
Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today the FDA clearance of its EZ Shot 3 Plus 25 G needle as well as an expanded...

08:00
BTG plc (LSE: BTG) announced that the US Food & Drug Administration (FDA) has approved updating the shelf life of CroFab® Crotalidae Polyvalent Immune Fab (Ovine) to 60 months and the removal of mercury from the product's manufacturing process. The...

06:30
Ardelyx, Inc. , today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting U.S. marketing authorization of tenapanor for the treatment of patients with irritable bowel syndrome with...


12 septembre 2018

07:30
Amneal Pharmaceuticals, Inc. , today announced it has received U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application (ANDA) for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg and...

06:00
Exact Imaging (www.exactimaging.com), the world's leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announced it has received Health Canada approval for its FusionVutm application for...

00:59
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Praluent® (alirocumab) Injection, a PCSK9 inhibitor. The sBLA outlines a...


10 septembre 2018

18:03
AliveCor, recently recognized as the Most Innovative Company in Artificial Intelligence, today announced that the U.S. Food and Drug Administration has given the company's KardiaK Software Platform the rarely granted designation of "Breakthrough...

15:30
The U.S. Food and Drug Administration (FDA) has recommended amendment of the Association of American Feed Control Officials (AAFCO) ingredient definition of dried black soldier fly larvae (BSFL) to include feeding to poultry.  The approval of BSFL...

15:12
Genesys Spine is pleased to announce the FDA clearance of our latest product line, the AIS-C Stand-Alone System. The AIS-C Stand-Alone system is a first of its kind, non-screw based, zero-profile, direct-anterior...


7 septembre 2018

09:42
GTEC Holdings Ltd. ("GTEC" or the "Company") is pleased to announce that its wholly owned subsidiary, Zenalytic Laboratories ("Zen Labs") received an approval from Health Canada expanding the scope of its Dealers License effective September 6, 2018....

09:05
Perrigo Company plc today announced that it has received final approval from the U.S. Food & Drug administration for the store brand over-the-counter equivalent of Imodium® Multi-Symptom Relief (loperamide hydrochloride and simethicone tablets, 2...


6 septembre 2018

06:00
ITF Pharma, a U.S.-based specialty pharmaceutical company and a subsidiary of Italfarmaco, a privately-held European specialty pharmaceutical company, committed to investing in and commercializing impactful medicines in therapeutic areas with...

02:57
NeuroVive Pharmaceutical AB   today announced positive U.S. Food and Drug Administration (FDA) feedback on its NeuroSTAT clinical development plan for the treatment of moderate to severe Traumatic Brain Injury (TBI) at a pre-IND (Investigational New...


5 septembre 2018

16:27
AMDT Holdings, Inc. (AMDT) is pleased to announce FDA clearance for their patented SixFix deformity analysis and correction software and instrumentation. AMDT Holdings, Inc. develops new products to address the existing and emerging needs of the...

10:22
ARMGO Pharma, Inc., a clinical stage biopharmaceutical company advancing a novel class of small molecule drugs known as Rycals®, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ARM210 (also...


4 septembre 2018

13:10
To increase utilization of biosimilars, the Academy of Managed Care Pharmacy (AMCP) is urging the U.S. Food and Drug Administration (FDA) to issue final guidance on interchangeability standards and develop educational materials that underscore the...

07:05
CytoSorbents Corporation a critical care immunotherapy leader using its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that the REFRESH 2-AKI trial...

07:00
Aquestive Therapeutics, Inc. , a specialty pharmaceutical company focused on identifying, developing and commercializing differentiated products to address unmet medical needs, today reported financial results for the second quarter ended June 30,...


31 août 2018

14:31
Aquestive Therapeutics, Inc. today announced that Sympazantm (clobazam) oral film has received tentative approval by the U.S. Food and Drug Administration (FDA), for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS)...

12:34
Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Jivi® (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of hemophilia A in previously treated adults and...


30 août 2018

07:00
Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Jivi® (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of hemophilia A in previously treated adults and...


29 août 2018

08:30
Trovagene, Inc. , a clinical-stage oncology therapeutics company, using a precision medicine approach to develop drugs for the treatment of leukemias, lymphomas and solid tumor cancers, today announced that the European Commission (EC) has endorsed...


28 août 2018

10:00
Pivotal trial results assessing the safety and efficacy of IDx-DR, an autonomous AI diagnostic system that detects diabetic retinopathy, were published online today in the peer-reviewed, open access journal Nature Digital Medicine. IDx-DR enables...

00:01
Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, exhibits data highlighting comparable safety and efficacy of its INNOVO® therapy, an externally worn...


27 août 2018

11:48
Merial, now part of Boehringer Ingelheim, received approval from the U.S Food and Drug Administration (FDA) to expand the label claims for NexGard (afoxolaner), the chewable flea and tick product that is preferred by dogs.1  The product is now...

08:00
Cantex Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing proprietary pharmaceuticals for the treatment of cancer, today announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation for...

07:05
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of Waldenström's macroglobulinemia (WM), a rare...

07:00
AbbVie , a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved IMBRUVICA® (ibrutinib) plus rituximab (RITUXAN®) for the treatment of adult patients with Waldenström's...

05:00
Novasep's robust quality assurance system, fully compliant with the highest world standards, showcased during successful FDA inspection of the Chasse-sur-Rhône (France) facility  Novasep, a leading supplier of services and technologies for the...

05:00
La robustesse du système d'assurance qualité de Novasep, pleinement conforme aux normes internationales les plus strictes, a été démontrée lors de l'inspection réussie par la FDA des installations du site de Chasse-sur-Rhône (France)  Novasep,...


24 août 2018

10:25
Ortho Dermatologics, one of the largest prescription dermatology health care businesses in the world and a division of Bausch Health Companies Inc. , today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug...

06:40
BIOCODEX SAS est ravie d'annoncer que la Food and Drug Administration (FDA) a autorisé le 20 août 2018 le DIACOMIT (stiripentol) dans le cadre du traitement des crises associées au syndrome de Dravet (SD) chez des patients âgés de 2 ans et plus sous...


23 août 2018

12:23
- Le développement de la cénégermine est le fruit de dizaines d'années de recherches italiennes issues des travaux menées par Rita Levi Montalcini, lauréate du Prix Nobel de médecine pour la découverte du facteur de croissance des cellules...

12:00
BIOCODEX SAS is pleased to announce that on August 20th, 2018, the Food and Drug Administration (FDA) has approved DIACOMIT (stiripentol) for the treatment of seizures associated with Dravet syndrome (DS) in patients 2 years of age and older taking...

09:23
Seqirus, a global leader in influenza vaccine innovation, today announced FDA approval of its next generation cell-based manufacturing process at Holly Springs, North Carolina.  The approval will enable Seqirus to more than double current production...

08:00
Dtheratm Sciences , the leading digital therapeutic company focusing on the elderly and individuals with neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to the...

07:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced approval from the U.S. Food and Drug Administration (FDA) for the cobas® EGFR Mutation Test v2 as a companion diagnostic test (CDx) with IRESSA®. A CDx test provides information that is essential for...

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