Le Lézard

News by subject: FDA

1 2 3 4 5 6 7 8 9 10 11 12 13

26 august 2019

11:49
US WorldMeds, LLC announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for MYOBLOC® (rimabotulinumtoxinB) injection for the treatment of chronic sialorrhea in adults.1 ...

09:00
Biobeat, a bio-medical technology company developing advanced sensing and remote monitoring solutions for patients, announced today that the U.S. Food and Drug Administration (FDA) has granted a 510K clearance for its patch and watch for measurement...

09:00
DiscGenics, Inc., a clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that the U.S. Food and Drug...

06:45
Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial...


22 august 2019

08:00
Drawbridge Health today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the OneDrawtm A1C Test System, comprised of the OneDraw Blood Collection Device and the OneDraw A1C Test. The...


21 august 2019

14:00
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the filing of a supplemental New Drug Application (sNDA)...


20 august 2019

12:13
Cassiopea SpA (SIX: SKIN), a specialty pharmaceutical company developing and commercializing prescription drugs with novel mechanisms of action (MOA) to address long-standing and essential dermatological conditions, announced today that it has...


19 august 2019

17:39
Boston Scientific Corporation announced the U.S. Food and Drug Administration (FDA) approval of its ImageReadytm MRI labeling for the Vercise Geviatm  Deep Brain Stimulation (DBS) System to be used in a full-body magnetic resonance imaging (MRI)...

15:11
The U.S. Food and Drug Administration today approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia. "This new drug provides another option for the treatment of patients with...

07:30
ActoBio Therapeutics, Inc., a wholly owned subsidiary of Intrexon Corporation and innovative clinical-stage biotechnology company focused on a new class of microbe-based therapeutic agents, announced that the U.S. Food and Drug Administration (FDA)...


16 august 2019

22:56
A new medical device for treating scoliosis, curvature of the spine, has received FDA approval, providing an alternative that both corrects the curve and maintains flexibility in the spine. The FDA's clearance is for The Tethertm, which uses patented...

17:12
The U.S. Food and Drug Administration today approved the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronization...

16:34
CVRx, Inc., a private medical device company, announced today that it has received Premarket Approval (PMA) from the United States Food and Drug Administration (FDA) to market its BAROSTIM NEO device for heart failure in the United States. The FDA's...

12:43
AbbVie , a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQtm (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with...

11:55
Edwards Lifesciences Corporation , the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced U.S. Food and Drug Administration (FDA) approval to expand use of the Edwards SAPIEN 3 and...

11:08
Zimmer Biomet Holdings, Inc. , a global leader in musculoskeletal healthcare, today announced U.S. Food and Drug Administration approval for The Tethertm for treatment of scoliosis, providing a fusion-less alternative for young patients requiring...

10:31
The U.S. Food and Drug Administration today approved the first spinal tether device intended to be used in children and adolescents to correct the most common form of scoliosis, called idiopathic scoliosis, that has not responded to conservative...

09:46
Today, the U.S. Food and Drug Administration approved Inrebic (fedratinib) capsules to treat adult patients with certain types of myelofibrosis. "Prior to today, there was one FDA-approved drug to treat patients with...


15 august 2019

15:37
The U.S. Food and Drug Administration today granted accelerated approval to Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene...

10:08
EmphyCorp Inc. www.EmphyCorp.com, a Private Corporation, is proud to announce the completion of a clinical trial to define medical endpoints as requested by the FDA for the NDA marketing application in patients with Pulmonary Fibrosis, under its...

08:00
Harmony Biosciences, LLC (Harmony) announced today that the U.S. Food and Drug Administration (FDA) approved WAKIX® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. WAKIX is the first and only...


14 august 2019

13:55
Today, the Food and Drug Administration (FDA) announced its approval of pretomanid, a new drug developed to treat Extensively Drug-Resistant Tuberculosis (XDR-TB) and treatment intolerant/non-responsive Multidrug-Resistant (MDR) TB. RTI International...

12:54
The U.S. Food and Drug Administration today approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs....

09:47
FDA has cleared Pollogen's RF home-use device ? TriPollar Stop ? for sale in the US. TriPollar Stop, the innovative home-use device developed by Pollogen, is based on the company's clinically-proven, patented RF technology, and has enjoyed broad...


13 august 2019

13:30
DynoSense Corp. announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its patented Vital Signs Measuring System, the world's first most integrated and cloud-based vital signs measuring and recording...

07:00
EYLEA is the only anti-VEGF approved to treat four retinal conditions with a single dose strength prefilled syringe EYLEA is available in multiple dosing intervals, offering doctors flexibility to address patients' individual needs Regeneron...


12 august 2019

08:00
Shimadzu Medical Systems USA, a subsidiary of Shimadzu Corporation, is proud to announce that they have received FDA 510(k) clearance for the FLUOROspeed X1, patient side conventional RF table system. Shimadzu Medical...


8 august 2019

11:21
Dynacure, a clinical stage drug development company focused on improving the lives of patients with rare and orphan disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for DYN101, an...


7 august 2019

10:19
The Critical Path Institute (C-Path) and the National Organization for Rare Disorders® (NORD) will host a meeting on Tuesday, September 17 in Bethesda, MD to formally launch development of a new rare disease data and analytics platform. Funded by a...

08:00
Blueprint Medicines Corporation , a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug...

07:00
Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug...


6 august 2019

10:19
Dalent Medical, a Miami-based company developing innovative devices for Ear, Nose & Throat Doctors is pleased to announce that the Sinusleevetm Balloon Sinus Dilation Sleeve has completed the United States Food and Drug Administration's listing...

08:00
AACC 2019 ? New blood tests may help healthcare providers identify if patients are sensitized to up to 11 different molecular allergen component proteins found in dogs, cats, or horses. The assays analyze sensitivity to specific proteins found in the...

08:00
AACC 2019 ? Thermo Fisher Scientific has expanded its portfolio of analytical instruments for clinical diagnostic laboratories with the addition of three systems now listed as Class I medical devices with the United States Food and Drug...


5 august 2019

12:00
Achieve TMS, the nation's most trusted deep Transcranial Magnetic Stimulation (dTMS) provider, will begin offering treatments at its La Jolla center using a state-of-the-art and FDA-approved Neuro-Navigation system for patients with depression, OCD...

08:00
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced the Food and Drug FDA approval for VARIBAR® THIN LIQUID (barium sulfate) for oral suspension which is...

03:00
- TURALIO is the first and only approved therapy for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery - TGCT, also referred to...


2 august 2019

19:40
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration (FDA) approved TURALIOtm (pexidartinib) as the first and only treatment for adult patients with symptomatic TGCT associated with...

14:59
Today, the U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and...


1 august 2019

08:05
Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug...

07:00
Nektar Therapeutics and Bristol-Myers Squibb today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin (NKTR-214) in combination with Bristol-Myers...


31 july 2019

07:30
Mesa Biotech Inc. is a privately-held, molecular diagnostic company that has developed the Acculatm System, an affordable, sample-to-answer, CLIA-waived PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC)...


30 july 2019

20:20
The U.S. Food and Drug Administration (FDA) today approved Nubeqa® (darolutamide), an androgen receptor inhibitor (ARi), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1 The FDA approval is based on...

19:42
Mezzion Pharma Co. Ltd. today announced that top line data from the Phase 3 FUEL trial, which was designed to evaluate the safety and efficacy of udenafil for the treatment of certain adolescents with congenital single ventricle heart disease...

17:00
ZEUS Scientific, a leading global diagnostic solutions company, today announced the launch of its ZEUS Borrelia Modified Two-Tiered Testingtm (MTTT) algorithm following receipt of FDA 510(k) clearance from the U.S. Food and Drug Administration....


29 july 2019

08:55
Argentum Medical announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for Vapor Sulfur Mustard indication for its Silverlon Burn and Wound Care products. This is the first medical product cleared in the...

06:00
Magenta Medical, the developer of heart failure solutions based on proprietary miniaturized blood pump technology, today announced a financing round led by global venture capital firm New Enterprise Associates (NEA), with participation from existing...

04:00
Epygenix Therapeutics, Inc., a privately held biopharmaceutical company developing precision medicines for Dravet Syndrome, announced today that the Company has received an Investigational New Drug Application (IND) approval from the U.S. Food and...


27 july 2019

07:38
NeuroVive Pharmaceutical AB   today announced that the company's candidate drug NeuroSTAT, in development for treatment of moderate to severe traumatic brain injury, TBI, has received Fast Track designation from the US Food and Drug Administration,...


25 july 2019

10:22
Resonea, Inc., ("Resonea" or the "Company") a technology company founded to create a new standard for understanding sleep and breathing and their long-term impact on wellness, performance, and quality of life, announced that they obtained 510(k)...

1 2 3 4 5 6 7 8 9 10 11 12 13