Le Lézard

News by subject: FDA

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5 september 2023

05:00
Viatris Inc. , a global healthcare company, today announced U.S. Food and Drug Administration (FDA) tentative approval for a New Drug Application for abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension for the...


1 september 2023

15:00
The Parenteral Drug Association, Inc. (PDA), today announced Pulitzer Prize winning journalist Dominic Gates of the Seattle Times will present, "The Devastating Impact of Design and Manufacturing Quality Lapses at Boeing" during the second plenary...


31 august 2023

08:00
Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced that the U.S. Food and Drug Administration (FDA) has cleared expanded use of RELiZORB® to children...

06:45
Mallinckrodt plc , a global specialty pharmaceutical company, today announced that its Specialty Generics segment, operating as SpecGx LLC, received approval on August 25, 2023 from the United States Food and Drug Administration (FDA) for its...


30 august 2023

08:03
BionicM, an innovative Japanese medical device startup, is pleased to announce that it has received U.S. Food and Drug Administration (FDA) 510(k) exemption registration for Bio Legtm; its robotic prosthetic knee. This registration marks a...


29 august 2023

10:05
Mitsubishi Tanabe Pharma Canada (MTP-CA), a subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA), today announced that RADICAVA® Oral Suspension (edaravone) is now covered under the New Brunswick Drug Plan (NBDP) formulary (special...

08:30
In this free webinar, gain a comprehensive review of the new FDA guidance on covariate adjustment in clinical trials. Attendees will explore the advantages of covariate adjustment with a prognostic composite covariate ? maximizing trial efficiency in...

08:00
ICU Medical Inc., a worldwide leader in the development, manufacture and sale of innovative medical devices, today announced that the company has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for the Plum...


28 august 2023

11:00
Xandar Kardian, a Toronto-based industry leader in developing radar signal processing technology for presence detection and vital sign monitoring, has announced that it officially reached a new corporate milestone: 50 deployments of its technology...

08:45
Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical remission (per Adapted Mayo Score) and key secondary endpoints as an induction and maintenance treatment1,2Safety results...

08:00
Israeli medical devices manufacturer BioProtect Ltd. announced today that their BioProtect Balloon Implanttm System has been cleared by the FDA. The biodegradable balloon is a new generation spacer designed to provide optimal, consistent, and...

04:30
Harbour BioMed (the"Company", HKEX: 02142) announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to commence clinical trials of its first antibody drug conjugate (ADC) program HBM9033....


25 august 2023

09:00
Aetion®, the global leader in real-world evidence (RWE) technology and analytics, is pleased to announce that 'A Screening Tool to Evaluate whether Using Real-world Data to Support an Effectiveness Claim in an FDA Application has Regulatory...

05:44
AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (Together AusperBio), a clinical-stage biotech company committed to advancing antiviral therapies and vaccines, with a primary focus on achieving a functional cure for chronic hepatitis B...


24 august 2023

17:11
The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko, like Tysabri, is also...


23 august 2023

12:09
Comanche Biopharma Corp. today announced that they have received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the investigation of Comanche's asset CBP-4888 as a novel siRNA therapy for preeclampsia. Preeclampsia...

11:55
MediCardia Health announced the integration of wearable ECG from FDA registered consumer devices for use in remote monitoring of patients with and at risk for developing atrial fibrillation (AF). The advance marks an important milestone for the...

09:01
Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for Versi®HD with GuideMe Software, a completely...

07:00
PixCell Medical, an innovator of rapid hematology testing solutions at the point of care (POC), is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for direct capillary sampling with the HemoScreen...

06:03
The heart teams at the Piedmont Heart Institute in Atlanta, Georgia, USA and the University of Virginia Health System in Charlottesville, VA, USA, successfully performed the first two implantations in the US of the Trisol Transcatheter Tricuspid...

06:00
Aquedeon Medical, Inc., a Silicon Valley pioneering medical device company specializing in novel cardiothoracic solutions, is pleased to announce a significant milestone following receipt of FDA Investigational Device Exemption (IDE) approval to...


22 august 2023

10:30
Medcrypt, Inc., the proactive cybersecurity solution provider for medical device manufacturers (MDMs), today announced its partnership with NetRise, the company providing granular visibility into the world's XIoT security problem, to address critical...

09:38
Magenta Medical, developer of the world's smallest heart pump, announced today the completion of enrollment to its FDA-approved Early Feasibility Study with the Elevatetm percutaneous Left Ventricular Assist Device (pLVAD) for the high-risk...

09:00
Levita Magnetics, whose mission is to help more patients get access to better surgery, announced today it has received U.S. Food and Drug Administration (FDA) clearance for its MARStm platform....

07:00
Regenesis Biomedical, Inc., a medical devic­­e company focused on safe, non-drug, pain management, announced today commercialization of the new Reprieve by Regenesistm device (Reprieve). Reprieve is the only home-use shortwave diathermy device on the...


21 august 2023

18:10
Today, the U.S. Food and Drug Administration approved Abrysvo (Respiratory Syncytial Virus Vaccine), the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory...

16:00
Amgen today announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) will review data supporting the supplemental New Drug Application (sNDA) for the full approval of LUMAKRAS® (sotorasib) for adults with...

09:03
Sentient, the leading full-service provider to the aesthetic care industry, announced today that the U.S. Food and Drug Administration has approved Tixel by Sentient, its innovative non-invasive skin resurfacing technology, for the treatment of...

09:00
Harvard Apparatus Regenerative Technology, Inc.  ("Harvard Apparatus Regenerative Technology" or the "Company"), a clinical-stage biotechnology company developing the technology to regenerate organs inside the body to treat severe diseases, today...

09:00
Medical device startup NURAMI MEDICAL has received 510(k) clearance from the US Food and Drug Administration (FDA) for its electrospun nanofiber-based product, ArtiFascia® Dura Substitute, a resorbable Dural repair graft. Sales in the US will begin...

08:00
CanariaBio Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative immunotherapies for cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug...

06:00
GSK101 (IDE705) is being developed as a potential first-in-class Pol Theta Helicase Inhibitor in combination with niraparib in GSK-sponsored Phase 1/2 clinical trialGSK101 and niraparib combination development will focus on advanced solid tumors with...

02:30
Recently, magAssist's NyokAssisttm Interventional Ventricular Assist Device (hereinafter referred to as NyokAssisttm), has been granted designation as a breakthrough device by the U.S. Food and Drug Administration (FDA) in Breakthrough Device...


18 august 2023

16:34
Neurocrine Biosciences, Inc.  today announced the U.S. Food and Drug Administration (FDA) has approved INGREZZA® (valbenazine) capsules for the treatment of adults with chorea associated with Huntington's disease (HD).1 INGREZZA is the only selective...

08:42
Orange Photonics, a pioneer in revolutionizing HPLC technology, is proud to announce that the US Food and Drug Administration (FDA) has selected the LightLab 3 High Sensitivity (HS) Cannabis Analyzer to play a pivotal role in its efforts to regulate...

04:17
Calliditas Therapeutics AB , ("Calliditas"), today announced that the U.S. Food and Drug Administration (FDA) has accepted the submission for the supplemental New Drug Application (sNDA) for TARPEYO® (budesonide) delayed release capsules and granted...


17 august 2023

09:26
Quanta Dialysis Technologies® today announced that it has completed enrollment of its Home Run study for at-home hemodialysis. The Home Run study is a prospective, multi-center, open-label trial to assess the efficacy and safety of the Quanta...

09:00
Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the publication of a post-hoc analysis of the pivotal, Phase 3 study (MCI186-19) reviewing the effect of intravenous (IV) RADICAVA® (edaravone) on survival and additional disease...

07:30
Perimeter Medical Imaging AI, Inc. ("Perimeter" or the "Company") ? a commercial-stage medical technology company ? announced the first commercial placement of its flagship Perimeter S-Series OCT medical imaging system in the state of Georgia,...

07:00
BlueWind Medical, Ltd. today announced that the US Food and Drug Administration (FDA) granted a De Novo marketing request for the Revi System, a transformative tibial neuromodulation therapy for the treatment of the symptoms of urgency incontinence...


16 august 2023

14:10
HELSINGBORG, Sweden, Aug. 16, 2023 /PRNewswire/ ? Today, Acorai, a start-up medical device manufacturer from Sweden, has announced the initiation of a global clinical trial with the enrollment of its first patient in London, UK. Acorai was designated...


15 august 2023

17:27
The Melanoma Research Alliance (MRA) released the following statements from MRA Chief Science Officer Joan Levy, PhD and MRA Chief Executive Officer Marc Hurlbert, PhD on the Food & Drug Administration approval of Hepzato Kit for patients with uveal...

09:45
CathVision, a medical technology company developing innovative electrophysiology solutions designed to enhance clinical decision making in the EP lab, today announced the FDA clearance and commercial availability of the PVI AnalyzerTM and Signal...

08:11
Everest Medicines (HKEX 1952.HK)'s partner Venatorx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for cefepime-taniborbactam, an investigational...

08:00
OnCusp Therapeutics, a biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients worldwide, announced today the clearance of its Investigational New Drug (IND)...

07:30
ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, today announced the U.S....

04:00
Aurisco Pharmaceutical announced today that its API and FDF plant in Yangzhou, China has successfully passed a cGMP inspection by the US Food and Drug Administration (USFDA). The inspection, carried out by the FDA Consumer Safety Officer, Mrs....


14 august 2023

21:10
Delcath Systems, Inc. , an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that today the US Food...

12:33
Boehringer Ingelheim announced today that SENVELGO® (velagliflozin oral solution), a revolutionary new treatment for cats with...

08:30
DRI Healthcare Trust  (the "Trust"), a global leader in providing financing to advance innovation in the life sciences industry, has...

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