Le Lézard

News by subject: FDA

30 december 2020

11:28
Micro-Tech Endoscopy and Interscope inked a partnership agreement to collaborate and distribute the EndoRotor System for interventional gastroenterology. "Micro-Tech's position as a market disruptor with strong leadership provides significant scale...

09:51
SYNTAC Institute ("SYNTAC"), an Alberta-based non-profit organization dedicated to bringing legal psychedelic-assisted therapy to Canadians, is pleased to confirm that it has facilitated the first announced approval from Health Canada for an...


29 december 2020

10:00
ZetrOZ Systems, developers of the Sustained Acoustic Medicine (SAM) wearable ultrasound, an FDA-cleared bio regenerative medical device, is the global leader in development of SAM technologies. With its reapproval for expanded use in 2020, the use of...

08:00
Driven to help people be their best naturally through the unique properties of the hemp plant,  Miraflora has received USDA Organic Certification for its 160-acre farm in Boulder County, Colo....


28 december 2020

18:25
Today, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes...


24 december 2020

09:33
Interscope, Inc. announced today the receipt of FDA de novo clearance to market its EndoRotor® System in the United States for direct endoscopic necrosectomy (DEN), a minimally invasive treatment for walled-off pancreatic necrosis. The EndoRotor...


23 december 2020

10:33
PharmaNutra S.p.A. (the "Company"), specialised in iron-based nutritional supplements and in medical devices for muscles and joints, communicates that its patented Cetylated Esters (CFA) has been recognized as GRAS (acronym for Generally Recognized...

10:16
Today, Health Canada authorized the second COVID-19 vaccine in Canada, manufactured by Moderna. Health Canada received Moderna's submission on October 12, 2020, and after a thorough, independent review of the evidence, it has determined that the...

10:00
Bracco Diagnostics Inc., the U.S subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced that the U.S. Food and Drug Administration (FDA) has approved ProHance® (Gadoteridol) Injection, 279.3...

07:30
AbbVie announced today that the U.S. Food and Drug Administration (FDA) approved the update of the IMBRUVICA® (ibrutinib) Prescribing Information to include efficacy and safety data for the combination of IMBRUVICA with rituximab for the treatment...


22 december 2020

09:46
P+F Products + Features GmbH has been granted designation as a Breakthrough Device for the company's lead product, the TricValve® Transcatheter Bicval Valves System by the U.S. Food & Drug Administration on December 15th 2020. The TricValve® is a...

09:42
Nephron Pharmaceuticals Corporation is celebrating another milestone. The company today announced Food and Drug Administration (FDA) approval of the Nephron Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 60 mg/2 mL...


21 december 2020

21:00
SCONE Medical Solutions Inc. announced today that their product, the Self-Contained Negative Pressure Environment (SCONEtm) has been cleared by FDA and is available for sale to hospitals in the United States.  The SCONEtm uses negative pressure...

14:40
SCONE Medical Solutions Inc., a Phoenix-based MedTech startup, has pioneered a new strategy for PPE in healthcare facilities, aimed at reducing the risk of aerosol transmission of contagious diseases to healthcare workers (HCWs), other patients, and...

13:00
The Hanover Insurance Group, Inc. expects to issue its fourth quarter and full-year financial results after the market closes on Wednesday, February 3, 2021. The company expects to webcast a discussion of its results on Thursday, February 4, 2021,...

11:00
GT Biopharma, Inc. (GTBP.PA) an immuno-oncology company focused on innovative therapies based on the Company's proprietary NK cell engager (TriKEtm) technology platform is pleased to announce the presentation of additional interim data results for...

08:30
Anixa Biosciences, Inc. , a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application...

08:28
Israel-based Moebius Medical today announced that the US Food and Drug administration (FDA) has cleared their Investigational New Drug (IND) application to initiate a global multi-center Phase IIb clinical trial of MM-II, a novel candidate for the...


20 december 2020

19:00
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) submitted by its partner Karyopharm Therapeutics Inc. for oral...


18 december 2020

14:59
Slayback Pharma LLC announced today that it has received final approval for its Abbreviated New Drug Application (ANDA) for Merzee (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1 mg/20 mcg from the USFDA with a...

12:35
Today, the U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. "Today's approval marks the first oral drug in this class and it may eliminate some patients' need to visit...

11:30
Karyopharm Therapeutics Inc. , a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved XPOVIO® (selinexor), the Company's first-in-class, oral...

09:42
Arthrex, a global leader in minimally invasive orthopedic technology, announced today the launch of the SwiveLock® ACL Repair Kit, following clearance by the U.S. Food and Drug Administration of the SwiveLock® anchor for ACL repair. It is the first...

08:13
Occlutech, a privately-held company, announced today that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for Pulmonary Arterial...


17 december 2020

16:30
Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces it has received FDA approval for and launched its generic version of GlaxoSmithKline's Advair Diskus®1 (Fluticasone Propionate and Salmeterol Inhalation Powder,...

16:05
CNS Pharmaceuticals, Inc. ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced it will host a conference...

16:00
Amgen  today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNItm (rituximab-arrx), a biosimilar to Rituxan® (rituximab), for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia...

13:07
Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) for the MagicTouch SCB Sirolimus Coated Balloon Catheter, for the...

11:55
The Lupus Research Alliance (LRA) congratulates GSK on the U.S. Food and Drug Administration (FDA) approval of belimumab (Benlysta®) as the first-ever treatment indicated specifically for adults with lupus nephritis (LN), a complication of systemic...

10:45
The U.S. Food and Drug Administration (FDA) has approved Benlysta to treat lupus nephritis (lupus-related kidney disease) in adults. The approval is for both the intravenous and subcutaneous formulations. The decision makes Benlysta the first lupus...

09:00
CNS Pharmaceuticals, Inc.  ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today announced that the Investigational...

08:59
GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food and Drug Administration (FDA) has approved BENLYSTA (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. Lupus nephritis is a...

07:00
FARAPULSE Inc. ("FARAPULSE" or "the Company") today announced the U.S. Food and Drug Administration (FDA) conditionally approved the Company's Investigational Device Exemption (IDE) application to initiate its U.S. pivotal ADVENT trial to evaluate...


16 december 2020

10:01
BIOTRONIK today announced FDA clearance and availability of the Vital Data Sensor, which identifies body temperature increases potentially associated with fever, in the new BIOMONITOR IIIm injectable cardiac monitor (ICM), as shown in a published...

09:00
Okami Medical Inc., a medical device company, today announced the expansion of its LOBOtm Vascular Occlusion System product line with the U.S. FDA 510(k) clearance of the LOBO-5 Vascular Occluder. ...

08:30
DURECT Corporation today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to DUR-928 for the treatment of alcoholic hepatitis (AH, also known as alcohol-associated hepatitis). AH is an acute,...

08:15
Avenda Health, a software and medical device company that spun out of UCLA, announced today that the Food and Drug Administration (FDA) has cleared their focal laser ablation system.  Avenda Health Receives FDA Clearance for their Office-Based Focal...

08:00
Medtronic plc announced that the U.S. Food and Drug Administration (FDA) has cleared the use of navigated interbody and Midas Rextm high speed drills with the Mazortm Robotic Guidance System earlier than originally anticipated. The Mazortm platform...

07:55
HemoShear Therapeutics, a clinical stage company developing treatments for rare metabolic disorders, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designations to HemoShear's HST5040 oral small...

06:30
 SMA is a rare genetic disease that leads to progressive muscle weakness, paralysis and, when left untreated in its most severe form, permanent ventilation or death for most patients by age 22,3 Zolgensma (onasemnogene abeparvovec) is approved for...


15 december 2020

12:03
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test...

08:30
binx health, a first-of-kind population health technology company, announced today that it received an important amendment to its COVID-19 Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), this time for centralized...

08:15
Exero Medical, developer of a wireless system for early detection of anastomotic leaks (AL) following gastrointestinal (GI) surgery, today announced that it has been granted FDA Breakthrough Designation ? a status reserved for medical devices that...

08:00
VERO Biotech LLC, an Atlanta, Georgia-based biotechnology company focused on saving lives, alleviating suffering, and improving the health economics of care, today announced that the U.S. Food and Drug Administration (FDA) has approved use of the...

07:00
Almirall, S.A. (BME:ALM), a global biopharmaceutical company focused on skin health, announced today that Klisyri® (tirbanibulin) has been approved by the U.S. Food and Drug Administration (FDA) for the topical treatment of actinic keratosis (AK) of...

02:00
- Klisyri® (tirbanibulin) is a novel microtubule inhibitor, indicated for the topical treatment of actinic keratosis (AK) on the face or scalp - Actinic keratosis is the second most common diagnosis made by dermatologists in the United States[1] -...


14 december 2020

12:04
Today, the U.S. Food and Drug Administration approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. This is the first IGA in an...


13 december 2020

19:30
Gannex, a wholly owned company of Ascletis Pharma Inc. (HKEX:1672) and fully dedicated to the R&D and commercialization of new drugs in the field of NASH, announced today that it received Fast Track designation from the U.S. Food and Drug...


11 december 2020

23:14
The leaders of 18 pharmacy organizations today issued the following statement following the Food and Drug Administration's approval of the first Emergency use Authorization for the COVID-19 vaccine. "We heartily welcome the decision by the US Food...

13:01
Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Asenapine Sublingual Tablets in 2.5mg and 10mg strengths (generic for Saphris®). ...