Le Lézard

News by subject: FDA

10 september 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 september 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 september 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 september 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 september 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 august 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 august 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 august 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 august 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 august 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...


24 august 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...


23 august 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 august 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 august 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 august 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 august 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 august 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 august 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...