Le Lézard

News by subject: FDA

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17 june 2021

07:02
The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research has granted approval to Sanofi Pasteur, the vaccines global business unit of Sanofi, for an additional influenza manufacturing facility located in Swiftwater,...

02:24
Elekta (EKTA-B.ST) announced today that its Elekta Harmony* radiation therapy system recently received U.S. FDA 510(k) clearance, paving the way for U.S. clinics to harness the system to treat a comprehensive range of indications using the latest...


16 june 2021

15:50
Blueprint Medicines Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved AYVAKITtm (avapritinib) for the treatment of adult patients with advanced systemic mastocytosis (Advanced SM), including aggressive SM...

13:55
Neo Medical, a Swiss-based Medtech company developing value-based care solutions for Functional Fusion in spinal surgery, announced today two major regulatory milestones for the European and the US markets. First, Neo Medical received FDA 510(k)...

13:13
Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Carfilzomib Intravenous Powder (generic for Kyprolis®). This product was developed in...

10:59
MannKind Corporation and United Therapeutics Corporation reached a major milestone today with the announcement that the U.S. Food and Drug Administration (FDA) accepted for priority review of the New Drug Application (NDA) for Tyvaso DPItm (inhaled...

10:03
SOFAR Americas, Inc., the U.S. subsidiary of Italy's leading digestive health company, SOFAR S.p.A., has announced that its AminoAlta probiotic plant-protein booster has achieved full self-affirmed GRAS status, which conveys and confirms its safety...

09:05
Ormco Corporation, a global leader of orthodontic solutions, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the use of its Sparktm Clear Aligner System for orthodontic treatment in patients with both primary and...

08:45
Ormco Corporation, a global leader of orthodontic solutions, today announced it has received FDA clearance to treat mixed dentition with its Sparktm Clear Aligner System, enabling orthodontists to treat younger patients. The clearance by the FDA...


15 june 2021

19:15
Mallinckrodt plc , a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen ? dsat) for the treatment...

15:10
Today, the U.S. Food and Drug Administration approved StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is clinically indicated (also...

09:00
LiquiGlide, the inventors of a breakthrough technology that's revolutionizing products, packaging, processes, and patient experiences by eliminating the friction between solids and liquids, has announced that the U.S. Food and Drug Administration...

09:00
The latest version of Transpara, the leading AI system that identifies potential breast cancers faster and earlier than before, has been cleared after rigorous investigation by the FDA. Transpara is already CE marked. Transpara, developed by...

09:00
VoluMetrix, a Nashville-based biotech startup dedicated to creating a new wave of solutions for vital monitoring to enhance well-being, today announced that its NIVAHF device has been designated as a Breakthrough Device by the U.S. Food and Drug...

08:50
As part of its mission to offer people living with Parkinson's and their families with high-quality educational resources on navigating the disease journey, The Michael J. Fox Foundation for Parkinson's Research (MJFF) today launches "Deep Brain...


14 june 2021

20:46
Asieris Pharmaceuticals (Asieris) today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application of oral APL-1202 in combination with BeiGene's tislelizumab as neoadjuvant therapy in...

08:30
Health Logic Interactive Inc. ("Health Logic" or the "Company") is pleased to report positive preliminary proof-of-concept test results of its first urine creatinine chip prototype (uC-Chip beta version), which successfully validated the clinically...

08:00
BioVaxys Technology Corp. (FRA: 5LB) ("BioVaxys"), is pleased to announce today that the US Food and Drug Administration (FDA) has reviewed its Pre-IND request for a Type B review of its CoviDTH program and has determined that a Written Response is...

08:00
Lipocine Inc. , a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the Company's Investigational New Drug Application ("IND") to...


11 june 2021

02:46
Vicore Pharma Holding AB (publ) ("Vicore"), a rare disease pharmaceutical company developing innovative medicines for fibrotic lung disorders such as idiopathic pulmonary fibrosis (IPF), today announces that the U.S. Food and Drug Administration...


10 june 2021

09:00
Medtronic plc , the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval for Vantatm, a high performance recharge-free implantable neurostimulator (INS) with a device life that can be...

08:30
Nuvo Group?a private company commercializing INVU by Nuvotm, an FDA-cleared, patent-protected, prescription-initiated remote pregnancy monitoring platform?today announced that it has received clearance from the U.S. Food and Drug Administration (FDA)...

08:17
CBMG Holdings (or the "Company"), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, today announced updated clinical data for C-CAR039, a novel CD19/CD20 bi-specific CAR-T cell product in relapsed...

07:13
Cardinal Health today announced that LYMPHOSEEK® (technetium Tc 99m tilmanocept) injection ? the first and only radiopharmaceutical agent specifically designed for targeted lymphatic mapping and guiding sentinel lymph node biopsies (SLNB) ? has been...


9 june 2021

08:00
CyMedica Orthopedics, a leading therapy-based digital health innovator, today announced the U.S. Food and Drug Administration (FDA) has cleared the submission of its latest technology for the management of knee osteoarthritis pain, IntelliHab. With...

08:00
Ibex Medical Analytics, the pioneer in AI-powered cancer diagnostics, today announced the granting of Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA), which will help fast track the clinical review and regulatory...

03:00
Dynacure, a clinical-stage company focused on developing and commercializing novel therapies to transform the lives of patients with rare diseases who have limited or no treatment options, announced today that the US Food and Drug Administration...


8 june 2021

12:18
Alpha Tau Medical, the developer of the pioneering alpha-radiation cancer therapy Alpha DaRT,TM is pleased to announce that it has received a Breakthrough Device Designation for Alpha DaRT from the U.S. Food and Drug Administration (FDA). This...

08:47
Elute, Inc., announced today it has received authorization from the US Food and Drug Administration (FDA) to use its EP Granules with Tobramycintm in a pivotal clinical trial. This Investigational Device Exemption (IDE) authorization, involving the...


7 june 2021

16:29
Neurimmune welcomes the news that the U.S. Food and Drug Administration (FDA) has approved Biogen's regulatory application for the use of aducanumab in the treatment of Alzheimer's disease. Alzheimer's disease - the leading cause of dementia in...

13:57
The Alzheimer Society of Canada is hopeful about the U.S. Food and Drug Administration's (FDA) approval of aducanumab, a new treatment for Alzheimer's disease. This news represents an important step forward for people living with Alzheimer's...

13:31
On behalf of those impacted by Alzheimer's disease, the Alzheimer's Association enthusiastically welcomes today's historic FDA approval of aducanumab (Biogen/Eisai) for treatment of Alzheimer's disease....

12:32
Today, the U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer's, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a...

12:25
Today's FDA approval of the monoclonal antibody Aduhelm (aducanumab) to treat patients with Alzheimer's disease reflects years of significant advances in Alzheimer's research. This is the first new Alzheimer's drug approved in 17 years and the first...

09:00
Medtronic plc , the global leader in medical technology, today announced the U.S. Food and Drug Administration (FDA) approval and first U.S. implants of the SenSighttm Directional Lead System used for Deep Brain Stimulation (DBS) therapy. SenSight is...


4 june 2021

17:17
Today, the U.S. Food and Drug Administration approved Ryplazim (plasminogen, human-tmvh) for the treatment of patients with plasminogen deficiency type 1, also referred to as hypoplasminogenemia, a disorder that can impair normal tissue and organ...

15:46
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Wegovytm (semaglutide) injection 2.4 mg, the first-and-only prescription weight-loss medication with once-weekly dosing....

15:30
Liminal BioSciences Inc. ("Liminal BioSciences" or the "Company") announced today that the U.S. Food & Drug Administration (FDA) has approved Ryplazim® (plasminogen, human-tvmh) ("Ryplazim®") for the treatment of patients with plasminogen deficiency...

15:12
Today, the U.S. Food and Drug Administration approved Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type...

07:00
EUA supported by pivotal Phase 3 data showing 1,200 mg dose reduced risk of hospitalization or death by 70% Only antibody therapy currently available in all 50 states, including eight states with high rates of two variants of concern...


3 june 2021

10:15
MicuRx Pharmaceutical Co., Ltd. (MicuRx), a leading biopharmaceutical company focused on the discovery, development and commercialization of antibacterial agents against drug-resistant bacterial infection, announced that China National Medical...

07:00
Protagonist Therapeutics ("Protagonist" or "the Company") , today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its lead investigational new drug candidate, rusfertide, for the treatment...


2 june 2021

13:28
PALO ALTO, Calif., June 2, 2021 /PRNewswire/ ? Cognoa, a pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with behavioral health conditions, today announced that the U.S. Food and Drug...

08:00
Medical imaging AI specialist Avicenna.AI today announced that it has received certification in the United States and European Union for CINA CHEST, its new AI solution that leverages deep learning algorithms for emergency triage of deadly vascular...

07:00
Kedrion Biopharma and Kamada Ltd.  and , two leading biopharmaceutical companies specialized in plasma-derived protein therapeutics, announced today the U.S. Food and Drug Administration (FDA) has approved a label update for KEDRAB® (Rabies Immune...

06:59
Bausch Health Companies Inc. ("Bausch Health") and Bausch + Lomb, its leading global eye health business, along with Clearside Biomedical, Inc. ("Clearside"), a biopharmaceutical company dedicated to developing and delivering treatments that...


1 june 2021

16:42
Novartis, a leader in immuno-dermatology and rheumatology, today announced the U.S. Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients six years and...

16:15
Edwards Lifesciences today announced that Acumen Hypotension Prediction Index (HPI) software with the Acumen IQ finger cuff has received U.S. Food and Drug Administration clearance. This is the first noninvasive solution that unlocks Acumen HPI...

11:34
Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Everolimus Tablets (generic for Zortress®). This product was developed in...

10:00
Eclipse, a leading aesthetic and medical manufacturer, is pleased to announce FDA clearance of their latest medical-grade microneedling device, the MicroPen EVO. Successfully launched last year in Canada, the MicroPen EVO is now available to...

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