Le Lézard

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

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9 juillet 2018

06:59
BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced it has completed the acquisition of TVA Medical, Inc., a company that develops minimally invasive vascular access solutions for patients with chronic...

05:00
OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC). OBI-3424 is a first in...


5 juillet 2018

21:41
Lipogems, a leader in medical technologies for orthopaedic physicians, announced U.S. Food and Drug Administration (FDA) clearance of the company's Lipogems Microfragmented Adipose Tissue Transplant System.  Federal regulators have cleared the way...


2 juillet 2018

10:31
Shortly after WAT Medical's leading product to treat nausea-induced vomiting, EmeTerm, received its FDA clearance earlier in April, it has now also received official clearance from Health Canada. Health Canada ensures all of its certified medical...

08:30
RiceBran Technologies  ("RBT"), a global leader in the production and marketing of value-added products derived from rice bran, announced today that the Company has received notification that the Food and Drug Administration (FDA) has granted RBT's...

07:05
Compugen Ltd. (CGEN) , a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, was informed that the U.S. Food and Drug Administration (FDA) has cleared Bayer AG's investigational new drug (IND) application for...

07:01
Alkermes plc  today announced that the U.S. Food and Drug Administration (FDA) has approved ARISTADA INITIOtm (aripiprazole lauroxil) for the initiation of ARISTADA® (aripiprazole lauroxil), a long-acting injectable atypical antipsychotic for the...

07:00
Compugen Ltd. , a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on its investigational new drug (IND)...

06:00
Advanced Ingredients® applauds the recent announcement by the U.S. Food and Drug Administration (FDA) to recognize resistant dextrin as a dietary fiber under U.S. Labeling Law. The FDA guidance serves as confirmation of our long-standing position of...

00:49
ReCor Medical announced today that the US Food & Drug Administration approved the Company's new pivotal study of the Paradise Ultrasound Denervation System for the treatment of hypertension: RADIANCE-II. Building upon the recent positive results of...


29 juin 2018

16:16
Founders and advisors of Carpe, a company that manufactures over-the-counter antiperspirant hand and foot lotions marketed to hyperhidrosis sufferers, expressed their excitement over a recent product announcement made by biopharmaceutical firm...

14:10
Today, Arthrosurface, Inc., a leading provider of minimally invasive, motion preserving joint restoration systems, announces their recent FDA 510(k) Clearance to market the Patellofemoral (PF) WaveKahuna Arthroplasty System. The PF...

13:02
The U.S. Food and Drug Administration today approved a new device, the Zephyr Endobronchial Valve (Zephyr Valve), intended to treat breathing difficulty associated with severe emphysema. "Treatment options are limited...

07:32
gel-e Inc., announces the 510(k) clearance of gel-e FLEX by the U.S. Food and Drug Administration (FDA) for the over-the-counter use of its first flowable hemostat. This new clearance expands the Company's label that...


28 juin 2018

14:56
In the news release, American Regent Announces the FDA Approval of Hydroxyprogesterone Caproate Injection, USP; the First Preservative Free, AP Rated Generic to Makena®*(1), issued June 28, 2018 by American Regent over PR Newswire. We are advised by...

08:04
American Regent today announced the launch of Hydroxyprogesterone Caproate Injection, USP, the only preservative free generic alternative to Makena®. Hydroxyprogesterone Caproate Injection, USP is indicated to reduce the risk of preterm birth in...

07:00
Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Tesera® SA Hyperlordotic ALIF Interbody Spinal Fusion System....


27 juin 2018

16:15
Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review its supplemental new drug application (sNDA) seeking revised labeling for Xyrem® (sodium oxybate) oral solution, CIII, to include...

13:44
Array BioPharma Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVItm capsules in combination with MEKTOVI® tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or...

09:00
Beckman Coulter Diagnostics announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new high-sensitivity troponin (hsTnI) assay, Access hsTnI, for use on the Access 2, DxI and the entire Access family...

08:58
FN Media Group News Commentary  There's no doubt that cannabidiol or CBD has seen a remarkable increase in popularity across the globe. The popularity is sure to grow even more as the U.S. Food and Drug Administration (FDA) approved the use of a...


25 juin 2018

20:24
The LGS Foundation is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved EPIDIOLEX® (cannabidiol / CBD) for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients two years age or older....

13:36
Zetta Medical Technologies announces their new FDA cleared software ZOOMtm. Zetta Medical Technologies announces the release of its latest MRI software algorithm for image quality enhancement and image optimization of...

13:27
Over the past decade, we've seen a growing interest in the development of therapies derived from marijuana and its components. Proponents of "medical marijuana" advertised its uses for a wide number of medical conditions, such as cancer, multiple...

13:16
The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years...

06:00
FRESCA Medical, Inc., a privately held sleep solutions and connected health company, announced today that the U.S. Food and Drug Administration (FDA) granted their de novo request to market the CURVEtm Positive Airway Pressure delivery system for the...


22 juin 2018

15:29
TVA Medical, Inc. today announced it has received U.S. Food and Drug Administration (FDA) De Novo marketing authorization of the everlinQ® endoAVF System. This innovative, minimally invasive technology uses magnetic catheters and radiofrequency...

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...

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