Le Lézard

News by subject: FDA

2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20

4 march 2021

14:26
Oxford Immunotec Global PLC (the "Company"), a global, high-growth diagnostics company, announced that today it has released the T-SPOT.COVID test, a CE marked ELISPOT based test intended for qualitative detection of a cell mediated (T cell) immune...

11:00
ControlRad, Inc., a privately held medical technology company focused on dramatically reducing unnecessary radiation exposure during fluoroscopically guided procedures, has announced the U.S. Food and Drug Administration (FDA) 510(k) clearance to...

09:00
Quibim, a global leader in whole-body medical imaging analysis, announced today the launch of qp-Prostate, its latest and most advanced prostate AI based Magnetic Resonance (MR) solution, after receiving 510(k) clearance by the US Food and Drug...

00:59
Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial Dupixent has the potential to be a...


3 march 2021

15:41
Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announced today the U.S. Food and Drug Administration (FDA) approval of once-daily oral capsule...

09:30
Dialectic Therapeutics, Inc. (Dialectic®), a Texas-based biotechnology company focused on creating innovative new technologies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) has concluded that Dialectic may proceed...

08:00
On Target Laboratories, Inc., a privately-held biotechnology company developing fluorescent markers to target and illuminate cancer during surgery, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application...

08:00
eXIthera Pharmaceuticals, a clinical-stage biotechnology company focused on addressing bleeding complications associated with currently available antithrombotic agents through the targeted inhibition of coagulation Factor XIa, today announced the...

00:00
Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd., announces that the FDA granted Fast Track Designation of OKN-007, the proprietary drug for Diffuse Intrinsic Pontine Glioma (DIPG). The FDA...


2 march 2021

10:46
Anuncia Inc., an emerging leader in Cerebral Spinal Fluid (CSF) management, received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its ReFlowtm System Mini intended for the treatment of CSF disorders requiring shunting...

08:46
Fifth EyeTM, a provider of intuitive real-time clinical analytics, today announced the U.S. Food and Drug Administration (FDA) has granted De Novo classification for its Analytic for Hemodynamic Instability (AHI). AHI can continuously monitor any...

08:00
Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) (hereinafter referred to as "Cipla") today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray, 20 mg from the United States Food and...

02:12
Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) (hereinafter referred to as "Cipla") today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Sumatriptan Nasal Spray, 20 mg from the United States Food and...


1 march 2021

16:15
TransMedics Group, Inc. ("TransMedics") , a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart and liver failure, today announced that the FDA's Office of Health Technology 2...

14:05
Q30 Innovations is pleased to announce the FDA's recent authorization to market the Q-Collar in the United States. The FDA clearance is a major step forward in the company's mission to help better protect athletes from the effects of repeated head...

12:55
Bio-Tissue, Inc., a TissueTech, Inc. company and pioneer in the clinical application of human birth tissue-based products, announced today that its parent company TissueTech had received clearance from the U.S. Food and Drug Administration (FDA) to...

11:34
Memic, a medical device company dedicated to transforming robot-assisted surgery with its proprietary technology, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization of its Hominis®...

09:58
The U.S. Food and Drug Administration has authorized marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate transvaginal hysterectomy in certain patients. The Hominis Surgical System is...

09:00
Feb 27th, 2021, the U.S. Food and Drug Administration granted IND approval for Q-1802 from QureBio.Ltd. Q-1802 is a bispecific antibody which can target PD-L1 and Claudin18.2 simultaneously. This is the first FDA-approved bispecific antibody against...

07:40
Oncopeptides AB (publ) ,  a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved PEPAXTO® (melphalan flufenamide),...

06:00
Vascular Grafts Solutions (VGS) Ltd. announced today receipt of marketing clearance from the Food and Drug Administration (FDA) for the VIOLAtm, a new device for clampless proximal anastomosis in coronary artery bypass grafting (CABG)....


27 february 2021

19:10
Johnson & Johnson (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson &...

18:41
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA...


26 february 2021

18:10
Today, the U.S. Food and Drug Administration approved Nulibry (fosdenopterin) for injection to reduce the risk of death due to Molybdenum Cofactor Deficiency Type A, a rare, genetic, metabolic disorder that typically presents in the first few days of...

17:43
Johnson & Johnson (the Company) today announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend Emergency Use Authorization (EUA) for the...


25 february 2021

16:51
B. Braun Medical Inc. (B. Braun), a leader in infusion therapy and pain management, today announced that they have received approval from the U.S. Food & Drug Administration for the first and only Acetaminophen Injection available in multiple doses....

14:37
Today, the U.S. Food and Drug Administration granted approval for Amondys 45 (casimersen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping...

08:49
According to Pew Research Center, women of childbearing age in the United States have greater hesitancy about the COVID-19 vaccines compared to men. A contributing factor is likely the lack of data available regarding the effect of COVID-19 vaccines...


24 february 2021

19:30
Gannex, a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672), fully dedicated to the R&D and commercialization of new drugs in the field of nonalcoholic steatohepatitis (NASH), today announces the Investigational New Drug Application (IND)...

19:14
AbbVie today announced that the U.S. Food and Drug Administration (FDA) approved HUMIRA® (adalimumab) for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. In clinical trials, HUMIRA...

05:00
G21® S.r.l., a bone cement manufacturer company, is pleased to announce the clearance of SpaceFlex Shouldertm as a completion of its existing Spaceflex line: Hip and Knee. "The achievement of this result for G21® S.r.l. means being able to offer a...


23 february 2021

15:34
Specialty Enzymes & Probiotics is proud to announce SEBiotictm received a No Objections Letter from the FDA for its GRAS, which stands for Generally Recognized As Safe, submission....

14:00
BodiMetrics, the global leader in medical ring sensor technology, today announced the results of a clinical study that validates the efficacy and reliability of their CIRCULtm Ring pulse oximeter in dark-pigmented participants, positioning it as a...

12:54
OrthoGrid® Systems, Inc., a global medtech leader on a mission to digitally transform intraoperative musculoskeletal surgery, announces the launch of its new OrthoGrid Hip software application after receiving FDA clearance on February 18, 2021. The...

09:30
Inovise Medical today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its AUDICOR® heart failure management system. The system uses clinically tested algorithms to detect the risk of...

09:18
Elicio Therapeutics, a private biotechnology company developing a pipeline of potent immunotherapies based on its proprietary lymph-node targeting Amphiphile technology, announced it has received Investigational New Drug (IND) clearance from the U.S....

09:15
Ampio Pharmaceuticals, Inc. , a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today announced the addition of two new study sites to further the expansion of its ongoing U.S....

09:00
Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is pleased to announce the 510(k) clearance of the NOVA Lite® DAPI dsDNA Crithidia luciliae (CLIFT) Kit by the US Food and Drug...

08:02
Hoth Therapeutics, Inc. , a biopharmaceutical company, today announced today the successful completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the Company's development plan for their HT-001 product. The...


22 february 2021

13:00
Libtayo was superior in extending overall survival compared to chemotherapy in a pivotal trial that allowed for certain disease characteristics frequently underrepresented in advanced NSCLC trials This is the third approval for Libtayo in the U.S....

12:37
Today, the U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2,...

10:53
Piccolo Medical, Inc. announces that it has received FDA clearance of its SmartPICCtm System. The SmartPICCtm System provides caregivers the ability to navigate peripherally inserted central catheters (PICCs) to the entryway of the heart without...

08:00
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world's leading companies in the diagnostic imaging business, announced today that its ultrasound enhancing agent (UEA) LUMASON® (sulfur hexafluoride lipid-type A...

07:00
Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, announces U.S. Food and Drug Administration (FDA) conditional Investigational Device Exemption (IDE) approval to commence its pivotal clinical trial called...


18 february 2021

09:00
Medtronic plc , the global leader in medical technology, today announced it has received approval from the United States Food and Drug Administration (FDA) for expanded MRI labeling of its InterStimtm II and InterStimtm Micro sacral neuromodulation...

08:00
FX received their 510k clearance for the Easytech® Stemless Anatomic. It is the only stemless shoulder prosthesis on the market with primary peripheral fixation. The new addition has been long awaited as it has been approved for use in Europe since...

08:00
Astellas Pharma Inc. (TSE: 4503, President and CEO:  Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. today announced completion of submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration...

07:55
Almirall, S.A. (BME:ALM), a global biopharmaceutical company focused on skin health, announced today the U.S. commercial launch of Klisyri® (tirbanibulin), developed for the topical treatment of actinic keratosis (AK) of the face and scalp....


17 february 2021

17:38
Additive Orthopaedics, LLC., announced today it has received an approval order from the U.S. Food and Drug Administration ("FDA") for its Humanitarian Device Exemption ("HDE") application for the Patient Specific Talus Spacer for treatment of...

15:45
Everlywell, a leading digital health company, today announced that the Everlywell COVID-19 Test Home Collection Kit DTC is now available for broad use without a prescription, including purchase by asymptomatic individuals, retailers, pharmacies, and...

2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20