Le Lézard

News by subject: FDA

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20 november 2019

08:00
Q BioMed Inc. ,  announces FDA approval of its contract manufacturer IsoTherapeutics Group LLC (ITG). ITG is now cleared to manufacture the Company's FDA approved non-opioid cancer bone pain drug Strontium-89 Chloride USP. The long-awaited approval...


18 november 2019

16:59
Accord Healthcare Limited ("Accord") and ADIENNE Pharma & Biotech S.A. ("ADIENNE") have entered into an exclusive licencing and distribution agreement for the commercialisation of TEPADINA® (thiotepa) 15mg and 100mg lyophilized powder for injections....

11:46
Novartis has announced that the U.S. Food and Drug Administration approved its new drug to treat sickle cell disease. The therapy, known as Adakveo, is based on discoveries made by Oklahoma Medical Research Foundation physician-scientist Rodger...

10:34
Cerapedics, a private ortho-biologics company, today announced the U.S. Food and Drug Administration (FDA) has approved the company's Premarket Approval (PMA) supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and...

08:30
CooperVision announced today it has received U.S. Food and Drug Administration (FDA) approval of its innovative MiSight® 1 day contact lens1. The cornerstone of a comprehensive myopia management approach to be offered by CooperVision, this daily...

08:00
Levo Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LV-101 (intranasal carbetocin) for the treatment of Prader-Willi syndrome (PWS). Levo is currently enrolling participants...

06:50
Protalix BioTherapeutics, Inc.  , a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, and its...


15 november 2019

18:58
Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. Commonly referred to as biologics, these medicines are generally made from natural or living sources, like animal and plant...

17:29
The U.S. Food and Drug Administration today approved the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of 8 and 12 years old at the initiation of treatment. The MiSight contact lens is a...

16:32
Novartis announced today that the US Food and Drug Administration (FDA) approved Adakveo® (crizanlizumab-tmca), previously known as SEG101, to reduce the frequency of vaso-occlusive crises (VOCs), or pain crises, in adult and pediatric patients aged...

15:17
Today, the U.S. Food and Drug Administration approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis ? a common and painful complication of sickle cell disease that occurs when blood circulation is...

14:01
The U.S. Food and Drug Administration today cleared for marketing in the U.S. the first duodenoscope with a sterile, disposable elevator component that will reduce the number of parts that need to be cleaned and disinfected (reprocessed) in between...


14 november 2019

18:13
The U.S. Food and Drug Administration today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible...

15:45
Today, the U.S. Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy....

08:00
Following the recent March approvals of Novartis' Mayzent and EMD Serono's Mavenclad, Genentech's Ocrevus continues to dominate neurologists' stated preference across the three segments of patients with progressive forms of multiple sclerosis (MS):...

08:00
Ultromics, the UK-based health technology firm at the forefront of applying artificial intelligence to echocardiography, has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for its image analysis system, EchoGo Core....

03:00
Ultromics, the UK-based health technology firm at the forefront of applying artificial intelligence to echocardiography, has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for its image analysis system, EchoGo Core. The...


12 november 2019

10:30
Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for an Abbreviated New Drug Application for Erlotinib Hydrochloride Tablets, generic for Tarceva®.  The Abbreviated New Drug...

08:00
Viracta Therapeutics, Inc. (the "Company"), a precision oncology company targeting virus-associated malignancies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for nanatinostat in combination with...

08:00
Moleculin Biotech, Inc., ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, announced that the FDA has approved a request for Investigational New Drug...

07:00
Alkermes plc today announced the receipt of a $150 million milestone payment from Biogen triggered by the recent U.S. Food and Drug Administration (FDA) approval of VUMERITYtm (diroximel fumarate), a novel oral fumarate with a distinct chemical...


8 november 2019

12:27
Today the U.S. Food and Drug Administration granted approval to Reblozyl (luspatercept?aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions....

08:00
 ? A new study of 443 patients by Exact Sciences Corp. and its collaborators demonstrated 80% sensitivity at 90% specificity with a novel combination of six blood-based biomarkers for the most common type of liver cancer, hepatocellular carcinoma...


7 november 2019

22:31
Camurus AB today announces that the U.S. Food and Drug Administration (FDA) has granted Camurus' US partner Braeburn's request (through Citizen Petition) to revoke orphan drug designation of Sublocadetm.1 In a separate decision FDA upheld its...

16:19
UVision360 Inc., creators of the patented LUMINELLE® DTx Hysteroscopy System, announced today the 510(k) clearance and launch of the latest addition to the LUMINELLE line, the 3mm LUMINELLE® Dx 360? Rotatable Disposable Sheath (Diagnostic). This new...

12:38
Thar Process, founded in 1990, announced today that after years of holding a Certified Organic certificate for algae extraction, it now holds the same for hemp.   After toll processing Certified Organic hemp for AVF Solutions from milling through...

07:08
TransThera Biosciences Co. Ltd, announced today that company received Orphan Drug Designation from US Food and Drug Administration (FDA) for TT-00420, a clinical stage investigational drug, for the treatment of cholangiocarcinoma. Dr. Frank Wu,...


6 november 2019

09:00
Today, 3D Systems  announced that its new biocompatible denture material, NextDent® Denture 3D+, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The combination of this new dental 3D printing material, NextDent 5100...

08:03
Vyaire Medical, Inc.'s bellavista 1000e ventilator has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA). It is the newest addition to Vyaire's high-end ventilation portfolio offering a comprehensive solution for...


5 november 2019

07:00
Nevro Corp. , a global medical device company that provides innovative, evidence-based solutions for the treatment of chronic pain, today announced it has received approval from the U.S. Food and Drug Administration (FDA) for the Senza® Omniatm...


4 november 2019

17:30
The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for Fluzone® High-Dose Quadrivalent (Influenza Vaccine) for use in adults 65 years of age and older. Fluzone® High-Dose (Influenza Vaccine) was...

11:39
LY03004, Luye Pharma's innovative, independently developed Extended-Release Microspheres for Injection has taken another step closer to going on the U.S. market. The company has announced that it has received the Establishment Inspection Report from...

09:00
Okami Medical Inc., a medical device company, today announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and initial launch of the LOBOTM Vascular Occlusion System. The Company further announced that...

08:01
Foamix Pharmaceuticals Ltd.  (Foamix or the Company), a specialty pharmaceutical company, announced today the peer review publication of the long term open label safety portions of studies FX2014-04 and FX2014-05 (Studies 04 & 05) in the Journal of...

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 has cleared its investigational new drug (IND) application for COM902, its...


31 october 2019

08:48
The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) granted Shreis Scalene Sciences (Shreis), in Gaithersburg, MD, 'Breakthrough Device Designation' for the CYTOTRON® - a CE marked, whole-body...

08:30
ANI Pharmaceuticals, Inc. ("ANI") today announced that its partner Pharmaceutics International Inc. (Pii) has received FDA approval of a Prior Approval Supplement for Bretylium Tosylate Injection, USP 500mg/10ml (50mg/ml).  ANI plans to launch this...


30 october 2019

20:00
Mizner Bioscience, LLC., today announced that they received the first US FDA approval for a therapeutically equivalent generic version of Elanco's Clomicalm®, (Clomipramine Hydrochloride Tablets). Approved by the U.S. Food and Drug Administration...


29 october 2019

13:56
The FDA granted Breakthrough Device status to Med-botics, LLC, (www.med-botics.com), for its Oxalert EPOTM (Enhanced Pulse Oximeter) device. The wrist-worn arousal device is designed to prevent respiratory arrest and death from opioid overdose. FDA...

07:00
Protalix BioTherapeutics, Inc.  , a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today...


28 october 2019

19:30
Pharmazz, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients in critical care, today announced that it successfully submitted Application for Marketing Authorization of...

11:35
Qunuba Sciences, a world leader in the development of cannabinoid delivery systems, is pleased to announce it has successfully earned a certificate for conformance with ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP). MDSAP is a...

09:00
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP1128 for patients at increased risk...

09:00
Medicines360, a global nonprofit organization with a mission to expand women's access to quality medicines, and Allergan plc , a leading global pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved Medicines360's...

06:01
SFA Therapeutics, Inc. announced today that FDA has granted an official Orphan Drug Designation (ODD) to SFA001, the company's novel human-microbiome-based treatment for human hepatocellular carcinoma (HCC). "By granting an Orphan Drug Designation to...


24 october 2019

13:03
Flowonix Medical, Inc. today announced approval from the United States Food and Drug Administration (FDA) to market the Prometra II® 40 mL Programmable Pump and its associated programmer software. This system approval expands the reservoir size...

08:00
Fresenius Medical Care North America (FMCNA), the nation's leading provider of kidney care products and services, announced today that the U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to a new hemodialysis...

07:30
Allergan plc today announced that the U.S. Food and Drug Administration (FDA) approved the company's supplemental Biologics License Application (sBLA) for BOTOX® for the treatment of pediatric patients (2 to 17 years of age) with lower limb...


23 october 2019

10:00
BlueWillow Biologics®, a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for BW-1010, the company's next-generation anthrax vaccine...


22 october 2019

15:00
The Alzheimer Society of Canada welcomes the news that Biogen and Eisai will seek regulatory approval from the U.S. FDA for the drug aducanumab based on results of a new analysis of the Phase 3 EMERGE clinical study which found a reduction of...

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