Le Lézard

News by subject: FDA

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9 march 2020

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...

05:00
F2G Ltd, a UK- and Austria-based biotech developing novel therapies for life-threatening systemic fungal infections, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead first-in-class...

02:08
Pharming Group N.V. (Euronext Amsterdam: PHARM) today announced it has also received US Food and Drug Administration (FDA) approval of Pharming's Prior Approval Supplement to...


6 march 2020

18:41
The U.S. Food and Drug Administration today approved Isturisa (osilodrostat) oral tablets for adults with Cushing's disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease. Cushing's disease...

09:00
Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, received FDA approval for their generic version of Thiotepa 15mg and 100mg vials for injection.  The product is supplied as a powder for...

02:26
Orexo AB (publ), today announces it has submitted an application to the US Food and Drug Administration (FDA) for vorvida® to enable commercialization in the US. vorvida®, is a digital therapy with clinically proven efficacy for the treatment of...


5 march 2020

10:00
Purolite Ltd., a leading manufacturer of resin-based separation, purification and extraction technologies, today announces that Praesto® Jetted A50, an agarose-based Protein A chromatography resin, has been incorporated into the commercial...

09:44
Allergan plc , a leading global pharmaceutical company with more than 70 years of heritage in eye care, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for DURYSTAtm (bimatoprost...


3 march 2020

09:00
XaTek Inc. today announced that the company has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its in-development ClotChip, marking a significant and distinguishing step in advancing the company's...

08:30
Tivic Health® Systems Inc., today announced that ClearUP® Sinus Pain Relief, a small handheld device that delivers a proprietary microcurrent waveform, has received CE Mark approval for temporary relief of sinus pain, pressure and congestion, under...

08:00
Access Vascular, Inc. today announced it has received FDA clearance for the second generation of its HydroPICCTM peripherally inserted central catheter (PICC), which has demonstrated a thrombus accumulation rate 30 times less than traditional PICCs1...

07:30
Stealth BioTherapeutics , a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that the U.S. Food and Drug...


2 march 2020

14:42
The U.S. Food and Drug Administration (FDA) has approved Sarclisa® (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least...

12:48
Today, the U.S. Food and Drug Administration approved Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including...

12:16
GID BIO announced today that The American Journal of Sports Medicine published results of its FDA-approved multi-site, randomized, placebo-controlled Phase IIb clinical trial measuring the safety and efficacy of its SVF-2 device and point-of-care...

09:00
Sebela Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved Pizensytm (lactitol) for oral solution for the once-daily treatment of chronic idiopathic constipation (CIC) in adults. Pizensy is a simple...

08:30
ANI Pharmaceuticals, Inc. ("ANI") today announced that it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for Memantine Hydrochloride Extended-Release Capsules 7 mg, 14...

08:00
FX received 510k clearances for their Glenoid Baseplate with a Central Screw and 32mm Glenosphere and Humeral Cups for reverse shoulder arthroplasty....

06:45
Pfizer Inc. and Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for tanezumab 2.5 mg administered subcutaneously (SC), which is being evaluated for...


28 february 2020

17:38
GlaxoSmithKline (LSE/NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved Advil Dual Action with Acetaminophen as an over-the-counter product for pain relief. The exclusive formula is now the first FDA-approved...

14:36
The U.S. Food and Drug Administration has approved an application for the first generic of Daraprim (pyrimethamine) tablets for the treatment of toxoplasmosis (an infection caused by the parasite Toxoplasma gondii) when used with a sulfonamide (a...


27 february 2020

19:37
Only 42% of people living with Type 1 diabetes count carbohydrates to determine their mealtime insulin dose according to the 2019 Seagrove Partners' Patients Perspectives Report. And it is generally accepted that anyone living with insulin-dependent...

16:11
Biohaven Pharmaceutical Holding Company Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved NURTECtm ODT (rimegepant) for the acute treatment of migraine in adults. NURTEC ODT is the first FDA-approved product for...

09:37
Specialty pharmaceutical company CMP Pharma, Inc. announced today that its Potassium Phosphates Injection, the first ever FDA Approved Potassium Phosphates Injection, was approved on September 19, 2019. This will provide Health Care Providers, for...

09:17
- There have been no newly approved therapies over the last 25 years for "high risk" locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) patients - The FDA decision was based on the compelling magnitude of the clinically phase II...

09:00
Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene and cell therapies, and consumer health products, welcomes the announcement by Blueprint Medicines...

08:00
Immunexpress, Pty Ltd & Inc., a molecular diagnostic company with the first FDA cleared host response assay for suspected sepsis patients, today announced that it has been successfully certified according to ISO 13485:2016 & EN ISO 13485:2016, the...


25 february 2020

09:11
Zynex, Inc. , an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, stroke rehabilitation, cardiac monitoring and neurological diagnostics, today announced the U.S. Food...

08:51
Cynosure, the global leader in medical aesthetics, announced today the U.S. Food and Drug Administration (FDA) clearance of the Potenzatm radiofrequency (RF) microneedling device, the first and only FDA-cleared four-mode RF microneedling device...

08:41
Emagine Solutions Technology, an award-winning medical software device company located in Tucson, announced that it has received clearance from the U.S. Food & Drug Administration ("FDA") to market its VistaScan mobile ultrasound platform.  The...

01:20
Halozyme Therapeutics, Inc. today announced that the U.S. Food and Drug Administration has accepted a Biologics License Application (BLA) from Genentech, a member of the Roche Group, for the fixed-dose combination of pertuzumab (Perjeta®) and...


24 february 2020

19:24
The U.S. Food and Drug Administration today approved the first generic of ProAir HFA (albuterol sulfate) Inhalation Aerosol for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway...

18:57
Perrigo Company plc and its partner, Catalent Pharma Solutions, today announced that the U.S. Food and Drug Administration (FDA) has approved Perrigo's abbreviated new drug application for generic albuterol sulfate inhalation aerosol, the first...

16:01
Avanos Medical, Inc. today announced the U.S. Food and Drug Administration (FDA) has cleared for marketing its new, 80-Watt COOLIEF* Radiofrequency (RF) system for neurological lesion procedures. This easy-to-use system, comprised of a newly...

13:31
Fresenius Medical Care North America (FMCNA) today announced that the U.S. Food and Drug Administration (FDA) has cleared Novalung®, a heart and lung support system for the treatment of acute respiratory or cardiopulmonary failure. Novalung is the...

08:30
Quadrivalent formulation of the first-and-only adjuvanted seasonal influenza vaccine for older adults (65+ years) receives FDA approval1  Designed with MF59® adjuvant to help strengthen, broaden and lengthen the body's immune response against the...

06:16
United Therapeutics Corporation and DEKA Research & Development Corp. today announced receipt of an additional 510(k) clearance by the U.S. Food and Drug Administration (FDA) related to the Unity Subcutaneous Delivery System for Remodulin®...


21 february 2020

19:50
The U.S. Food and Drug Administration (FDA) has approved Trulicity® (dulaglutide) for the reduction of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who have established cardiovascular (CV) disease or multiple...

08:37
In a report released this morning, the Personalized Medicine Coalition (PMC) explains how 12 personalized treatments and seven diagnostics the U.S. Food and Drug Administration (FDA) approved or cleared in 2019 will improve patient care and make the...


20 february 2020

16:05
BioMarin Pharmaceutical Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) to the FDA for its investigational AAV5 gene therapy, valoctocogene roxaparvovec,...

11:00
Companion Medical, manufacturer of InPen, the first FDA-cleared smart insulin pen and mobile app-based diabetes management system, today announced clearance by the FDA for the use of Novo Nordisk's Fiasp® rapid-acting insulin. The clearance adds to...


17 february 2020

10:00
GlaxoSmithKline (LSE/NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)- arthritis pain reliever) as an over-the-counter product for the...

02:30
PharmaMar (MSE:PHM) and Jazz Pharmaceuticals plc announce that the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the New Drug Application (NDA) seeking accelerated approval for lurbinectedin for the treatment of...


14 february 2020

17:32
The U.S. Food and Drug Administration today approved three drugs for nonprescription, or over-the-counter , use through a process called a prescription (Rx)-to-OTC switch. The FDA approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%)...


13 february 2020

09:46
The ANSI National Accreditation Board (ANAB), a wholly owned subsidiary of the American National Standards Institute (ANSI), has accredited BSI Group ANZ Pty Ltd. in accordance with the international standard ISO/IEC 17065, Conformity...


12 february 2020

10:44
THINK Surgical, Inc. announced that Houston-based INOV8 Surgical is the first health care facility in the state of Texas to acquire the TSolution One® active robot system, since the technology was cleared by the U.S. Food and Drug Administration...

05:00
CareLight Solutions is proud to now be offering a complete line of industry-leading Light Therapy products to the public. Inspired by Nobel Prize-winning science, Light Therapy devices are backed by years of scientific research and are FDA-cleared to...

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