Le Lézard

News by subject: FDA

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16 january 2019

12:32
The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in...

12:10
Immuno Concepts, a recognized pioneer in innovation of autoimmune diagnostic reagents and instrumentation, is pleased to announce that the United States Food and Drug Administration (FDA), through the 510(k) process, has cleared the Histofluor®...

10:30
MIM Software Inc., a leading global provider of medical imaging software, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for molecular radiotherapy (MRT) dosimetry. MRT...

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

09:00
Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, South Korea and a tenant company of JLABS@TMC in Houston, Texas, announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug...

08:00
Therachon AG ("Therachon"), a clinical-stage biotechnology company focused on the discovery, development and commercialization of innovative treatments for serious rare conditions, today announced that the U.S. Food and Drug Administration (FDA) has...


15 january 2019

08:19
Beleave Inc. ("Beleave" or the "Company") is excited to announce its wholly-owned subsidiary Beleave Kannabis Corp. has been authorized by Health Canada to sell cannabis oil products effective January 11, 2019. After reviewing the application and...


14 january 2019

16:47
The U.S. Food and Drug Administration has approved the expanded use of Adacel® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed) to include repeat vaccination to help protect against tetanus, diphtheria and...

16:00
Additive Orthopaedics, LLC., the leader in 3D printed orthopaedic foot and ankle devices, announces that is has received FDA 510(k) clearance for its Patient Specific 3D Printed Locking Lattice Plates indicated for alignment, stabilization and fusion...

09:00
Abbott  today announced the U.S. Food and Drug Administration (FDA) approved the Amplatzer Piccolotm Occluder, the world's first medical device that can be implanted in the tiniest babies (weighing as little as two pounds) using a minimally invasive...

07:30
Amneal Pharmaceuticals, Inc. , today announced that it has received FDA approval for a generic version of Exelon® Patch  (Rivastigmine Transdermal System), 4.6 mg/24 hours, 9.5 mg/24 hours, and 13.3 mg/24 hours. The Company is planning to...


11 january 2019

12:45
ulrich medical USA, Inc., a medical device company focused on developing and commercializing musculoskeletal implant technologies in the United States, announced today the market entry of a highly-anticipated, new generation vertebral body...

04:09
AWAK Technologies (AWAK), a pioneering medical technology company focused on dialysis using regeneration technology for end-stage renal disease, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device...


10 january 2019

08:30
TELA Bio®, Inc. and Aroa Biosurgery, the joint developers of OviTex® Reinforced BioScaffolds (RBSs) for soft tissue repair, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market large sizes of OviTex RBS. The...


9 january 2019

09:00
Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) headquartered in Hunt Valley, Maryland, is pleased to announce its partner, Academic Pharmaceuticals, Inc., received FDA approval of Bretylium...


8 january 2019

07:52
Embrace by Empatica has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use in children. Embrace is an epilepsy smartband that detects patterns in motion and physiological signals that may be associated with generalized...

07:37
Grifols, a leading producer of plasma- derived medicines and recognized leader in transfusion medicine, has received U.S. Food and Drug Administration approval of Erytra Eflexis, a fully automated, benchtop analyzer. The system performs...

06:00
ArcherDX, Inc., a molecular technology company dedicated to developing breakthrough solutions that advance the application of personalized genomic medicine, today announced that the U.S. Food and Drug Administration (FDA) granted a Breakthrough...


7 january 2019

10:00
MicroVention, Inc., a U.S.-based subsidiary of Terumo and a global neurovascular company, announced today the FDA Premarket Approval (PMA) for the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. The...


3 january 2019

15:32
Tivic Health Systems Inc. today announced that ClearUP Sinus Pain Relief, a first-in-class bioelectronic treatment for sinus pain due to allergic rhinitis (hay fever), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA)....

09:00
StemCyte is pleased to announce that the U.S. Food and Drug Administration (FDA), on December 14, 2018, approved its Phase II Investigational New Drug (IND) application for Allogeneic Human Leukocyte Antigen (HLA)-Matched Umbilical Cord Blood...

08:00
Bruin Biometrics, LLC ("BBI") has been granted U.S. Food and Drug Administration (FDA) marketing authorization for the SEM Scanner, a wireless handheld device that is indicated for use as an adjunct to the standard of care when assessing patients who...


2 january 2019

19:00
Ascletis Pharma Inc. (1672.HK), a commercial-stage biotechnology company addressing unmet medical needs in therapeutic areas including anti-viral, cancer and fatty liver diseases, announces today that the investigational new drug application (IND)...

08:00
Slayback Pharma LLC announced today that the U.S. Food and Drug Administration ("FDA") granted approval of its abbreviated new drug application ("ANDA") for Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 ml.  This is the first and only ANDA...


31 december 2018

08:30
Heron Therapeutics, Inc. , a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and...


28 december 2018

08:30
Edwards Lifesciences Corporation , the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the SAPIEN 3 Ultra system has received U.S. Food and Drug Administration (FDA)...


26 december 2018

09:04
The Michael J. Fox Foundation for Parkinson's Research (MJFF) announces the first regulatory approval of a Parkinson's treatment funded by the Foundation. Inbrija from Acorda Therapeutics, Inc. received approval from the U.S. Food and Drug...


23 december 2018

09:38
Camurus announced today that the US Food and Drug Administration (FDA) has issued Camurus' US partner Braeburn a tentative approval of Brixaditm (buprenorphine) extended-release injection for subcutaneous use, 8 mg, 16 mg, 24 mg, 32 mg (weekly) and...

09:00
Braeburn today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval of BRIXADI (buprenorphine) extended-release weekly (8mg, 16mg, 24mg, 32mg) and monthly (64 mg, 96mg, 128mg) injections. The tentative approval is...


21 december 2018

14:55
Stemline Therapeutics, Inc. , a biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted approval of ELZONRIStm...

12:35
Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation , and a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced that the US Food and Drug...

10:40
The U.S. Food and Drug Administration today approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease. "The...

10:23
The U.S. Food and Drug Administration today approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older....

08:54
An experimental first in class ADC medicine for high risk Her2 negative breast cancer, gastric, lung, bladder and ovarian cancer patients - US phase I clinical trial to be initiated. Oxford BioTherapeutics Ltd. ("OBT"), a clinical stage oncology...

07:55
Hemp Oil Canada, Inc., the global leader in ingredients, announces that the company's complete line of hemp seeds, oil and protein powder have received Food and Drug Administration (FDA) clearance as Generally Recognized as Safe (GRAS). This is a...

07:54
Manitoba Harvest, the global leader in hemp food, announces that the company's complete line of hemp seeds, oil and protein powder have received Food and Drug Administration (FDA) clearance as Generally Recognized as Safe (GRAS). This is a historic...


20 december 2018

20:00
Alma Lasers, GmbH, a global developer of innovative energy-based solutions for the aesthetic and surgical markets, announced today that it received a notice of completion from the US Food and Drug Administration (FDA) in response to questions about...

08:28
Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, announced today that the U.S. Food and Drug Administration (FDA) has agreed to the Company's proposed...

07:00
Vanda Pharmaceuticals Inc. (Vanda) today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of Vanda's Supplemental New Drug Application for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder. The FDA...

06:59
BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced the U.S. Food and Drug Administration 510(k) clearance of its BD MAXtm enteric viral panel, a molecular diagnostic test for the direct qualitative...


19 december 2018

17:37
Veloxis Pharmaceuticals announced today that the U.S. Food & Drug Administration (FDA) approved a new indication for Envarsus XR (tacrolimus extended-release tablets) to prevent organ rejection in de novo kidney transplant patients in combination...

08:07
Hycor Biomedical, a leading manufacturer of in vitro diagnostic products for allergy and autoimmune testing, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its new allergy testing system, NOVEOS....

08:00
Eiger BioPharmaceuticals, Inc. , focused on the development and commercialization of targeted therapies for rare and ultra-rare diseases, today announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for...

07:00
Anixa Biosciences, Inc. , a biotechnology company focused on using the body's immune system to fight cancer, today announced that it completed a Pre-Submission (Pre-Sub) meeting with the US FDA on December 17, 2018.  The...


18 december 2018

15:21
INSIGHTEC®, a global medical technology innovator of incisionless surgery, today announced that The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved an expansion of the indication of Exablate...

10:00
Palo Alto Health Sciences, Inc. (PAHS) announced today that its flagship digital therapeutic, Freespira®, has been cleared by the FDA as a treatment option for patients diagnosed with post-traumatic stress disorder (PTSD).   PTSD is serious and...

07:00
Cipher Pharmaceuticals Inc. today announced that its New Drug Submission ("NDS") for A-101 40% topical solution ("A-101 40%") for the treatment of raised seborrheic keratoses ("SKs") has been accepted for review by Health Canada. Cipher acquired the...

05:30
Achieve Life Sciences, Inc. , a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today provided a clinical development update. The...


17 december 2018

10:45
Global pharmaceutical company Mylan N.V.  today announced the U.S. launch of Mesalamine Delayed-Release Tablets USP, 1.2 g, a generic version of Shire's Lialda® Delayed-Release Tablets. Mylan Pharmaceuticals received final approval from the U.S. Food...

10:00
Sundial Growers Inc. ("Sundial") today announced that its Rocky View facility received its standard processing and sales license for medical purpose from Health Canada, allowing the company to begin selling its premium Alberta grown cannabis into the...

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