Le Lézard

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

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22 juin 2018

13:24
Today, the U.S. Food and Drug Administration permitted marketing of two catheter-based devices designed to create a connection to veins and arteries in patients with chronic kidney disease who need hemodialysis. ...

09:00
Processa Pharmaceuticals, Inc. a clinical stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have a high unmet medical need, announced today that the U.S. Food and Drug Administration...


21 juin 2018

17:32
The U.S. Food and Drug Administration today expanded the approval of the MiniMed 670G hybrid closed looped system, a diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with...

15:40
The U.S. Food and Drug Administration today approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and older with diabetes. This is the first FDA-approved CGM system to include a fully implantable sensor...

15:14
Senseonics Holdings, Inc. today announced the U.S. Food and Drug Administration has approved its Premarket Approval (PMA) application to market the company's Eversense® Continuous Glucose Monitoring (CGM) System to people with diabetes in the United...

08:25
Oramed Pharmaceuticals Inc. (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it has initiated a food effect study in the U.S. for its oral insulin capsule...


20 juin 2018

17:09
Tenon Medical, Inc., a manufacturer of minimally invasive instruments and implants for sacroiliac joint fusion surgery, today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the...

10:28
Acurx Pharmaceuticals, LLC ("Acurx" or the "Company"), a privately held clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections, today announced that the U.S. Food and Drug Administration (FDA)...

10:20
AIVITA Biomedical, a biotech company specializing in innovative stem cell applications, announced today the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase II clinical trial investigating...


19 juin 2018

16:02
Novartis announced today that the US Food and Drug Administration (FDA) approved the inclusion of new evidence that Cosentyx® (secukinumab) significantly slows the progression of joint structural damage at Week 24 versus placebo in those with active...

08:25
Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, announced today that it has received approval from the U.S. Food & Drug...

08:00
Spectra Medical Devices, Inc., a Massachusetts based leading medical device company, is making a major impact and servicing the high demand in the marketplace with its FDA approval and launch of 1% Lidocaine HC1 Injection USP, 1%, 5mL single use...


18 juin 2018

12:36
Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the U.S. Food & Drug Administration provided its first supplemental Abbreviated New Drug Application (sANDA) approval for the company's manufacturing facility in Monroe,...

09:00
Arcuro Medical Ltd. ("Arcuro"), a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T) , announced today that it received regulatory clearance from the United States Food and Drug Administration (FDA) for its SuperBalltm meniscus...

09:00
The Cefaly® ACUTE medical device, recently cleared by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine, is the subject of a large phase 3 clinical trial in the United States that is progressing rapidly. Previous pilot...

08:27
Johnson & Johnson Vision announced today the U.S. Food and Drug Administration (FDA) approval of the iDESIGN Refractive Studio, making it the only system to use topography-integrated, wavefront-guided technology.2 This allows doctors to take a...

08:00
DreaMed Diabetes, developer of personalized diabetes management solutions, announced today that the U.S Food and Drug Administration (FDA) has granted a De Novo request for DreaMed Advisor Pro, an artificial intelligence (AI)-based diabetes treatment...

02:45
Medivir AB today announced that the Board of Directors have decided to continue the discussions with the US Food and Drug Administration (FDA) to agree on the design of the planned pivotal phase III clinical study of remetinostat for the treatment...


15 juin 2018

12:00
Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced today that it has received final approval from the U.S. Food and Drug Administration (USFDA) and is launching Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg, 4...

10:11
Indivior PLC (LON: INDV) ("Indivior" or the "Company") today announced that it is aware that, on 14 June 2018, the US FDA approved generic versions of SUBOXONE® Film from both Dr. Reddy's and Mylan, and that Dr. Reddy's subsequently announced it has...

04:00
BlueWind Medical, entreprise qui développe une plateforme de neurostimulation miniature sans fil, destinée au traitement de multiples indications cliniques, a annoncé aujourd'hui que l'Agence américaine des produits alimentaires et médicamenteux...

04:00
BlueWind Medical, a developer of a miniature wireless neurostimulation platform, for the treatment of multiple clinical indications, announced today that the US Food and Drug Administration (FDA) has approved the company's pivotal study design for...


14 juin 2018

16:48
The U.S. Food and Drug Administration today approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence. "The FDA is...

09:30
Imaging Endpoints (IE) is proud to announce the successful completion of a Bioresearch Monitoring (BIMO) inspection by the U.S. Food and Drug Administration (FDA) at its corporate office in Scottsdale, Ariz., June 7, 2018. The inspection concluded...

09:00
BlueWind Medical, a developer of a miniature wireless neurostimulation platform, for the treatment of multiple clinical indications, announced today that the US Food and Drug Administration (FDA) has approved the company's pivotal study design for...

04:00
DyAnsys Europe SARL has announced that its parent company, DyAnsys Inc., has U.S. Food and Drug Administration clearance for an auricular neurostimulation device to treat the symptoms of opioid withdrawal without narcotics. The device, Drug Relief®,...

04:00
DyAnsys Europe SARL a annoncé que sa société mère, DyAnsys Inc., a obtenu l'autorisation de la Food and Drug Administration américaine pour un dispositif de neurostimulation auriculaire destiné à traiter les symptômes du sevrage aux opioïdes sans...


13 juin 2018

17:53
Medicines Development for Global Health (MDGH) and the World Health Organisation Special Programme for Research and Training in Tropical Diseases (TDR) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved...

09:00
Samus Therapeutics, Inc. ("Samus" or the "Company"), a privately held Boston-based biopharmaceutical company developing novel therapeutics and biomarkers targeting the epichaperome, today announced that the U.S. Food and Drug Administration (FDA) has...


12 juin 2018

17:36
REGENXBIO Inc. , a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that the U.S. Food and Drug Administration...

16:00
Ascletis announced today that China Food and Drug Administration (CFDA) has approved its Category 1 new drug, Ganovo (also known as Danoprevir or ASC08), for the treatment of viral hepatitis C. Ganovo is the first Direct-acting Anti-viral Agent (DAA)...

10:00
DyAnsys Inc. announced that the U.S. Food and Drug Administration has cleared its auricular neurostimulation device, Drug Relief®, to be used as an aid to reduce the symptoms of opioid withdrawal without narcotics. Drug Relief® is available now for...

09:00
icotec AG, a Swiss company, today announced that its latest line of interbody cages, designed to optimize bony integration and post-operative visualization has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The clearance includes...

07:00
MicroVention, Inc. a U.S.-based subsidiary of Terumo and a global neurovascular company, announced today the FDA clearance of a new clinical indication for the SOFIA® Catheter (Soft TOrqueable catheter For Intracranial Access) to include contact...

04:00
The BlackArmor® Carbon/PEEK cervical and lumbar interbody cages are composed of icotec's innovative material, which is radiolucent and rapidly integrates with the vertebral endplates thanks to the rough Ti-iT® titanium coating. icotec AG, a Swiss...

03:00
Les cages intersomatiques cervicales et lombaires BlackArmor®, en carbone et PEEK (polyéther-éther-cétone), sont composées du matériau innovant d'icotec, qui est radio-transparent et qui s'intègre rapidement avec les embouts vertébraux grâce au...


11 juin 2018

17:08
CryoLife, Inc. , a leading cardiac and vascular surgery company focused on aortic disease, today announces the publication of our clinical study entitled "Anticoagulation and Antiplatelet Strategies After On-X Mechanical Aortic Valve Replacement" in...

09:00
Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add the positive overall survival (OS) data from the Phase 3 ASPIRE trial to the U.S. Prescribing Information for...

08:15
OrthoSensor, Inc., a leader in sensor-assisted technology for total knee replacement (TKR), today announced it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for its VERASENSE* Sensor-Assisted Technology (VERASENSE) to...


10 juin 2018

23:27
Cellenkostm, Inc., a clinical-stage biotechnology company, today announced that the United States Food and Drug Administration has cleared the Investigational New Drug (IND) application which allows for Cellenkostm to proceed with a phase I clinical...


8 juin 2018

14:55
AbbVie , a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved, under priority review, VENCLEXTA® (venetoclax tablets) in combination with rituximab for the treatment of patients...


7 juin 2018

10:24
Amerigen Pharmaceuticals Limited ("Amerigen") today announced the commercial launch of its generic bexarotene 75mg capsules following the recent approval of the Company's corresponding Abbreviated New Drug Application ("ANDA") by the U.S. Food and...

10:00
Centinel Spine, LLC is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its FLXtm Platform of Integrated Interbodytm and non-integrated interbody fusion devices.  Centinel Spine is...

08:00
DarioHealth Corp. , a leading global digital health company with mobile health and big data solutions, announced today it has experienced a successful launch of its iPhone® 7, 8 and X compatible Blood Glucose Monitoring System following FDA...


6 juin 2018

07:54
Commercial-stage cancer biotech company, Partner Therapeutics, Inc. (PTx), announced the recent FDA approval of Leukine for the treatment of adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome...


5 juin 2018

09:00
Royal Philips , a global leader in health technology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Ingenia Elition 3.0T MR solution and two clinical applications, Philips Compressed...

06:45
Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new indication for ALIMTA® (pemetrexed for injection) in combination with carboplatin and KEYTRUDA® (pembrolizumab) for the initial...


4 juin 2018

16:58
The U.S. Food and Drug Administration today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of...

16:52
Mylan N.V. and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's Fulphilatm (pegfilgrastim-jmbd), a biosimilar to Neulasta® (pegfilgrastim), co-developed with Biocon....

11:00
Micronics, Inc. has announced today that its test for the detection of Shiga toxin-producing E. coli (STEC) has received clearance from the U.S. Food and Drug Administration. The Micronics PanNAT STEC Test is performed in a disposable...

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