Le Lézard

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

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23 août 2018

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...

06:45
Mallinckrodt plc , a leading global specialty pharmaceutical company, and NPXe Limited ("NeuroproteXeon" or "NPXe") today announced that the United States Food and Drug Administration (FDA) recently granted Fast Track designation to NPXe's Phase 3...


22 août 2018

22:35
Dompé today announced that the U.S. Food and Drug Administration (FDA) has approved OxervateTM (cenegermin-bkbj ophthalmic solution), a breakthrough therapy for neurotrophic keratitis (NK), a rare and progressive eye disease that can lead to corneal...

17:36
The U.S. Food and Drug Administration today approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye)....

15:30
Clarion Medical Technologies, a leading Canadian provider of medical and aesthetic equipment and consumables, is pleased to be the Canadian partner to Evolus, Inc.'s Health Canada approved DWP-450 (prabotulinumtoxinA) for the temporary improvement in...

10:09
COMPASS Pathways, a life sciences company dedicated to accelerating patient access to evidence-based innovation in mental health, has received approval from the US Food and Drug Administration (FDA) for a clinical trial in psilocybin therapy for...

09:27
COMPASS Pathways, a life sciences company dedicated to accelerating patient access to evidence-based innovation in mental health, has received approval from the US Food and Drug Administration (FDA) for a clinical trial in psilocybin therapy for...

08:00
For people suffering from severe depression, the road to remission just became a lot shorter: The treatment is known as Transcranial Magnetic Stimulation (TMS), and MagVenture has now, as the only TMS provider in the US, received FDA clearance...


21 août 2018

09:56
TECHLAB, Inc., a leading developer and manufacturer of rapid non-invasive diagnostic tests for gastrointestinal diseases, today announced that it received U.S. Food and Drug Administration (FDA) clearance for the H. PYLORI QUIK CHEKtm and the H....

09:32
Luminelle DTx Hysteroscopy System has received its 510(k) clearance from the FDA with a dual-indication for both hysteroscopy and cystoscopy.  The Luminelle DTx Hysteroscopy System is small, easy to use, cost effective and has the potential for an...


17 août 2018

10:03
Today, the U.S. Food and Drug Administration permitted marketing of the Brainsway Deep Transcranial Magnetic Stimulation System for treatment of obsessive compulsive disorder (OCD). "Transcranial magnetic stimulation has...

08:00
Eisai Inc. and Merck , known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor LENVIMA® (lenvatinib) for the first-line treatment of patients with...

07:00
Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular...


16 août 2018

16:11
Eisai Inc. and Merck , known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor LENVIMA® (lenvatinib) for the first-line treatment of patients with...

13:22
The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults...

09:18
Sirnaomics, Inc. (http://new.sirnaomics.com), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announces today that the U.S. Food and Drug Administration (FDA) has approved the company's first oncology IND...

08:00
Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a global healthcare company with a history of more than 75 years of improving people's health and well-being and a leader in the development of innovative diagnostic solutions, recently received...


14 août 2018

09:00
EarlySense, the market leader in contact-free continuous monitoring solutions across the care continuum, today announced that its system has been found to detect and alert for respiratory depression with high positive predictive value, according to a...

09:00
MolecuLight Inc. achieved a major regulatory milestone permitting expansion into the United States market.  FDA has granted De Novo clearance for the ground-breaking wound fluorescence imaging device, the MolecuLight i:X TM.  The device digitally...

08:42
MarketNewsUpdates.com News Commentary  The rising prevalence of cardiac conditions such as flutter, atrial fibrillation and arrhythmia has driven the adoption of medical procedures such as ablation and electrophysiology (EP) study. Electrophysiology...

08:00
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, today announced that the U.S. Food and Drug Administration (FDA) approved the...

07:14
Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is pleased to announce the clearance of QUANTA Flash® HMGCR by the US Food and Drug Administration (FDA). HMGCR is a marker...


13 août 2018

11:30
Medicure Inc. ("Medicure" or the "Company") , a cardiovascular pharmaceutical company, is pleased to announce that the United States Food and Drug Administration ("FDA") has approved its Abbreviated New Drug Application ("ANDA") for Sodium...

10:56
Global pharmaceutical company Mylan N.V. today announced the U.S. launch of Tadalafil Tablets USP, 20 mg, the first generic version of the reference listed drug, Eli Lilly and Company's Adcirca®.  Mylan Pharmaceuticals received final approval from...

09:47
Orsini Healthcare Specialty Pharmacy announced that it has been selected by Alnylam Pharmaceuticals, Inc to distribute ONPATTROtm (patisiran) lipid complex injection. Orsini Healthcare Specialty Pharmacy is one of two specialty pharmacies selected to...

09:47
In the news release, US Food And Drug Administration (FDA) Clears Natural Cycles As The First Digital Method Of Birth Control In The United States, issued Aug. 13, 2018 by Natural Cycles over PR Newswire, we are advised by the company that changes...

09:05
Ivantis, a company dedicated to developing new and innovative solutions for glaucoma, announced today that it received Food and Drug Administration (FDA) approval for the Hydrus® Microstent, a microinvasive glaucoma surgery (MIGS) device used to...

08:45
7D Surgical announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Cranial Module.  This achievement is a crucial step in the commercial launch of 7D Surgical's innovative Machine-vision Image...

08:00
Natural Cycles today announced that its application for De Novo classification as a Class II medical device has been granted by the United States (US) Food and Drug Administration (FDA), making Natural Cycles the only app to be cleared in the United...


10 août 2018

16:49
The U.S. Food and Drug Administration today approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease. The drug is indicated for adults with Fabry disease who have a genetic mutation determined to be...

15:22
The Population Council, a global nonprofit research organization, announced it has received U.S. Food and Drug Administration (FDA) approval for Annoveratm (segesterone acetate and ethinyl estradiol vaginal system), the first and only contraceptive...

14:12
The U.S. Food and Drug Administration today approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), which is a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring...

13:44
The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients. This is the first...

13:17
The U.S. Food and Drug Administration today permitted marketing of the first mobile medical application (app) that can be used as a method of contraception to prevent pregnancy. The app, called Natural Cycles, contains an algorithm that calculates...


9 août 2018

09:49
60 Degrees Pharmaceuticals (60P) announced today the U.S. Food and Drug Administration (FDA) approval of ARAKODAtm (tafenoquine) tablets for the prevention of malaria in patients aged 18 years and older. For the first time in more than eighteen...

09:04
Som Sleep announces its ready-to-drink sleep supplements, Som Sleep Original and Som Sleep Zero Sugar, are officially Non-GMO Project Verified. "We designed Som Sleep to fit seamlessly into people's lives by ensuring...


8 août 2018

15:00
BALTIMORE, Aug. 8, 2018 /PRNewswire-PRWeb/ -- Maryland Dermatology Laser Skin & Vein Institute is pleased to report the recent FDA approval of Restylane Lyft for the treatment of wrinkles and volume deficiencies in the hands. With age, hyaluronic...

13:21
The U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior...

12:32
CSTAR Cannabis Inc. ("CSTAR Cannabis") is pleased to announce that its application to become a Licensed Producer ("LP") under Health Canada's Access to Cannabis for Medical Purposes Regulations ("ACMPR") has progressed to the 'Active Review' Stage....

12:16
Kyowa Hakko Kirin Co., Ltd., (Kyowa Kirin) announces today that the U.S. Food and Drug Administration (FDA) has granted approval for Poteligeo® (mogamulizumab-kpkc) for the treatment of adult patients with relapsed or refractory mycosis fungoides...

12:16
The U.S. Food and Drug Administration today approved several strengths of potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation. This new approval pathway was created to expedite the...

09:00
Aidoc, a leading provider of AI solutions for radiologists announced today that it was granted Food and Drug Administration (FDA) clearance for the first product of its expanding suite of AI-based workflow optimization solutions. The clearance is for...

07:30
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 financial results for the quarter ended June...


7 août 2018

10:00
Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the U.S. Food & Drug Administration (FDA) has accepted for review the company's New Drug Application for its leading respiratory pipeline candidate Ryaltristm (rye - al'...

07:30
Lipocine Inc. , a specialty pharmaceutical company, today announced financial results for the three and six months ended June 30, 2018. Second Quarter and Recent Corporate Highlights Received a Complete Response Letter...

07:00
Prometic Sciences de la Vie Inc. (« Prometic ») a annoncé aujourd'hui avoir obtenu une désignation de maladie pédiatrique rare de la Food and Drug Administration (FDA) américaine pour son médicament candidat à base de petite molécule, le...

07:00
Prometic Life Sciences Inc.  ("Prometic") today announced that the U.S. Food and Drug Administration (FDA) has granted a Rare Pediatric Disease Designation to its small molecule drug candidate, PBI-4050, for the treatment of Alström syndrome (AS)....

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