Le Lézard

News by subject: FDA

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Today

10:00
Leica Biosystems, the global leader in pathology workflow solutions, today announced it has received notification from the U.S. Food & Drug Administration (FDA) that its Aperio ImageScope DX Viewer with images acquired on the Aperio AT2 DX Scanner...

08:30
ThermoGenesis Holdings, Inc. , a market leader in automated cell processing tools and services in the cell and gene therapy field, announced today that it was featured on a CBS 13 news segment titled, "Different Kind of Coronavirus Test", regarding...

06:59
BD (Becton, Dickinson and Company) , a leading global medical technology company, and BioGX Inc., a molecular diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a...


2 april 2020

11:00
Celularity Inc. ("Celularity" or the "Company"), a clinical-stage company developing allogeneic cellular therapies from human placentas, today announced the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug...

08:30
Outset Medical, a leading med tech innovator delivering first-of-its-kind technology into the growing global dialysis market, today announced the Food and Drug Administration (FDA) cleared the Tablo Hemodialysis System for patient use in the home....


1 april 2020

13:12
The U.S. Food and Drug Administration today approved Sevenfact [coagulation factor VIIa (recombinant)-jncw] for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with...

08:01
International medical imaging IT and cybersecurity company Sectra (STO: SECT B) has received a 510(k) clearance by the US Food & Drug Administration (FDA). The clearance applies for Sectra Digital Pathology Module, the key component of Sectra's...


30 march 2020

22:45
In response to the current global pandemic, COVID-19, Savage Enterprises is pleased to announce the newest product to join the Savage Essentials family, Savage Hand Sanitizer. As many industry leaders rush to aid the country because of the lack of...

11:02
Houston Methodist received FDA approval Saturday to become the first academic medical center in the nation to transfuse donated plasma from a recovered COVID-19 patient into a critically ill patient. This treatment was fast-tracked to the bedside...

09:50
Nuvo Group, a private company with a bold ambition to reinvent pregnancy care for the 21st century, today announced that it has received clearance from the U.S. Food & Drug Administration ("FDA") to market INVUtm, a prescription-initiated,...

08:00
Minor cuts and lacerations can be safely, quickly, and effectively treated at home with Clozex Medical innovative wound closures, reducing the risk of exposure to COVID-19 and other contagions. Stay safe and keep our medical professionals focused on...

08:00
Fluxergy LLC, a research and medical diagnostic test company based in Irvine California, has submitted an Emergency Use Authorization (EUA) request to the U.S. Food and Drug Administration (FDA) Center For Devices and Radiological Health, seeking an...

06:45
Eli Lilly and Company announced today the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Taltz® (ixekizumab) injection, 80 mg/mL for the treatment of pediatric patients (ages 6 to under...


28 march 2020

10:00
Ryvu Therapeutics (WSE: RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug...


27 march 2020

19:20
Abbott  announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive...

16:05
Luminex Corporation today announced that the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its NxTAG® CoV Extended Panel. The intended use of this multiplex test is the detection of the SARS-CoV-2 virus. High...

08:18
Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) and hereafter referred to as "Cipla") today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Esomeprazole for Oral Suspension 10mg, 20mg and 40mg from the...

08:03
BGI Genomics Co. Ltd. (SZSE:300676) and its US subsidiary BGI Americas Corp. today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its RT-PCR kit for detecting SARS-CoV-2....

06:00
EchoNous is proud to announce FDA approval of its KOSMOS Platform, which consists of a distinctive 8oz. ultrasound-based tool combined with deep learning for clinical assessment of the heart, lungs and abdomen. It is the first tool in medicine to...


26 march 2020

12:49
Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) resubmission for...

10:37
APR Applied Pharma Research s.a. ("APR"), the Swiss pharma company leveraging drug delivery technologies to develop innovative products for niche and rare diseases, today announced that the US Food and Drug Administration (the "FDA") has granted...

06:28
RELIEF THERAPEUTICS Holding AG (SIX: RLF) "Relief", together with NeuroRx, a Delaware Corporation, have filed an Investigational New Drug (IND) Application with the US FDA for a phase 2 trial of RLF-100 (Aviptadil) in the treatment of Acute and...

02:00
Thermo Fisher Scientific Inc. , the world leader in serving science, today announced that it has received the CE mark in the European Union for its diagnostic test to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19. "The CE mark...


25 march 2020

16:05
Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the company's New Drug Application (NDA) seeking marketing approval for JZP-258, an investigational medicine for the...

10:02
The PAP Foundation, Inc. ("PAPF") is the primary patient advocacy organization for Pulmonary Alveolar Proteinosis ("PAP") in the United States and consists of clinicians, scientists, PAP patients and their family members. With foundational goals of...


24 march 2020

09:00
BIOLASE, Inc. , the global leader in dental lasers, is pleased to announce the Epic Hygienetm laser received regulatory clearance for Laser Bacterial Reduction (LBR) therapy indication from the Food and Drug Administration (FDA). This new indication...

08:30
ANI Pharmaceuticals, Inc. ("ANI") , an emerging leader in the specialty pharmaceutical industry, today announced that it has submitted a prior approval supplement (PAS) to the Endocrinology Division at the FDA for re-commercialization of Purified...

07:55
DiaCarta Inc., a precision molecular diagnostic company, announced today that it has filed for Emergency Use Authorization (EUA) with the US FDA for its QuantiVirustm SARS-CoV-2 test and has validated the COVID-19 diagnostic test in its own CLIA...

07:00
Today, Mesa Biotech announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for its Acculatm SARS-CoV-2 Test, which gives COVID-19 diagnostic results in 30 minutes. Mesa Biotech Inc., a...


23 march 2020

09:00
AliveCor, the leader in artificial intelligence (AI)-based, personal ECG technology, and provider of enterprise cardiology solutions, today announced that its KardiaMobile 6L ? the world's only six-lead personal ECG ? is now allowed for use in the...


21 march 2020

09:00
Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert® Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, the virus causing...


20 march 2020

07:00
Biostage, Inc.  (Biostage or the Company), a bioengineering company developing next-generation esophageal implants, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug application ...


19 march 2020

14:38
The U.S. Food and Drug Administration today approved a supplemental application for Epclusa (sofosbuvir and velpatasvir) to treat hepatitis C virus (HCV) in children ages 6 years and older or weighing at least 37 pounds (17 kilograms) with any of the...


18 march 2020

10:02
BGI Genomics. Co. Ltd. (SZSE:300676) and US subsidiary BGI Americas Corp., today announced that its Real-Time Fluorescent RT-PCR test for detecting SARS-CoV-2 is now commercially available in the United States. With the updated guidance from FDA...


17 march 2020

11:00
Based on extensive research conducted by Kemin Industries, the Food and Drug Administration (FDA) Center for Veterinary Medicine has approved the use of chromium propionate as a source of chromium in horse diets. With this new approval, chromium...

06:45
Mallinckrodt plc , a global biopharmaceutical company, today announced the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for terlipressin, an investigational agent being evaluated...


16 march 2020

09:00
Thermo Fisher Scientific Inc. , the world leader in serving science, announced that on March 13, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for its diagnostic test that can be used immediately by...

06:45
Eli Lilly and Company and Incyte Corporation announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to baricitinib for the treatment of alopecia areata (AA), an autoimmune disorder that can...


12 march 2020

13:07
CoNextions Inc. (www.conextionsmed.com) announced today that it received a 510(k) clearance (K200028) from the U.S. Food and Drug Administration (FDA) for CoronetTM System, a tenodesis product intended for the fixation of tissue to bone and tissue to...

08:00
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of Jardiance® (empagliflozin) to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease,...

07:45
Agenus Inc. , an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Agenus Fast Track designation for...

07:00
Safety and Innovation in Aesthetics: Neauvia North America Launches the First and Only FDA Class II Cleared Plasma Device in the U.S. Market Neauvia North America has announced that the U.S. Food and Drug Administration (FDA) has given Class II...


11 march 2020

12:00
The US Food and Drug Administration provided market clearance to Fluidda for its Broncholab platform. Broncholab provides a number of Functional Respiratory Imaging (FRI) parameters to physicians via an online platform to assist in diagnosing and...

08:00
Soliton, Inc., ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center ("MD Anderson"), today announced U.S. Food and...


10 march 2020

14:03
AltaThera Pharmaceuticals, LLC, a hospital specialty pharmaceutical company focused on commercializing innovative drugs aimed at improving outcomes and reducing hospital costs, announces that the US Food and Drug Administration (FDA) has approved new...


9 march 2020

14:36
The U.S. Food and Drug Administration today approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait). It is the first FDA-approved treatment for...

13:52
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev® (nintedanib) as the first treatment for people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Unclassifiable...

10:47
Recordati today announces the FDA approval of Isturisa® (osilodrostat) for the treatment of patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative. Isturisa® is the first and only FDA?approved inhibitor...

10:00
U.S. FDA clears Transpara 1.6.0 manufactured by ScreenPoint Medical, the first breast AI solution for both 2D and 3D mammography in the USA. In order to obtain FDA clearance, the company performed a clinical reader study which demonstrated that...

08:00
Mylan N.V.  and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin® (bevacizumab), for...

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