Le Lézard

News by subject: FDA

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23 july 2019

08:11
Camurus AB today announces that the United States District Court for the District of Columbia grants Braeburn's motion for summary judgement, vacating the U.S. Food and Drug Administration's (FDA) decision to block final market approval of Brixaditm...


22 july 2019

13:25
MiRus is pleased to announce FDA 510(k) clearance of the GALILEOtm Spine Alignment Monitoring System, a non-optical, wireless, real-time measurement system for segmental and global sagittal spine alignment. The GALILEOtm Spine Alignment Monitoring...

10:44
On July 19, the U.S. Food and Drug Administration approved multiple applications for first generics of Lyrica (pregabalin) for the management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic...

09:45
Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, announced today that its development partnership with a leading medical products company has resulted in the U.S. Food and Drug Administration...

00:37
InvaGen Pharmaceuticals, Inc. ("InvaGen"), a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited (BSE: 500087; NSE: CIPLA EQ; hereafter referred to as "Cipla") announced the receipt of final approval for its Abbreviated...


21 july 2019

19:00
Ascentage Pharma, a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases, today announced that the company was notified by the U.S. Food & Drug...


19 july 2019

09:00
ID Genomics, SPC today announced the completion of its first Pre-Submission meeting with the Food and Drug Administration for the CLoNeT E. coli Assay for Urinary Tract Infections (UTIs). "We continue to make great strides in our development plans...


18 july 2019

07:00
CTI BioPharma Corp. ("CTI" or "the Company") today announced the outcome of a Type B, End-of-Phase-2a meeting with the U.S. Food and Drug Administration ("FDA" or "the Agency") for the continued development of its investigational myelofibrosis...


17 july 2019

19:05
The FDA has cleared the "truSculpt® flex" muscle sculpting & toning device, the first that is capable of treating up to eight body areas simultaneously.Dr. Dennis Dass says the truSculpt® flex device is designed to perform total body muscle toning...

08:43
The U.S. Food and Drug Administration has approved Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI)....

08:35
Erchonia Corporation, the global leader in the manufacturing and development of low level laser therapy technology ("3LT"), today announces that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its FX...

08:00
DURECT Corporation today announced that the U.S. Food and Drug Administration (FDA) has acknowledged that the submission of DURECT's full response to the Complete Response Letter (CRL) it previously received from FDA related to POSIMIR® (bupivacaine...

00:39
Q'Apel Medical announced today that it received U.S. Food and Drug Administration clearance for its novel walrus Balloon Guide Catheter (BGC).  In the neurovascular space where speed, reliability and performance are so...


16 july 2019

13:23
BTL, the manufacturer behind the game-changing EMSCULPT technology, is continuing to raise the bar in aesthetics and non-invasive body shaping. Today, the brand announced its latest FDA clearance for EMSCULPT, which is now FDA cleared to strengthen,...

07:15
LUTRONIC, a leading developer of energy-based medical devices, announced Tuesday that the U.S. Food and Drug Administration has granted market clearance for the Clarity IItm 755nm and 1064nm wavelength platform. On the heels of a successful launch of...

06:00
Medical Coaches (www.medcoach.com), a leading manufacturer of mobile medical clinics, has been selected to produce six mobile health units, specializing in medication-assisted treatment (MAT), in Colorado as part of the State's Opioid Response (SOR)...


15 july 2019

12:46
Abbott today announced the company has received U.S. Food and Drug Administration (FDA) approval for the most advanced MitraCliptm heart valve repair device to treat mitral regurgitation. The latest approval for the fourth-generation MitraClip...

12:05
MSN Labs, the parent company of Novadoz Pharmaceuticals, was granted FDA approval to market Abiraterone Acetate 250mg tablets, a generic version of Janssen Pharmaceuticals' product Zytiga©, on July 9th.  This FDA approval marks the ninth since March...

10:00
Bayer announced today the U.S. Food and Drug Administration (FDA) has approved Gadavist® (gadobutrol) injection for use in cardiac magnetic resonance (MR) imaging to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult...

08:57
Soom, a pioneer in utilizing barcode and knowledge graph technologies to bridge information gaps between data sources and physical products, has introduced SoomSafety, an iOS mobile app that allows users to scan a medical device and receive...


12 july 2019

13:19
Minister of International Development and Minister for Women and Gender Equality, the Honourable Maryam Monsef, on behalf of Canada's Minister of Natural Resources, the Honourable Amarjeet Sohi, will make a clean technology announcement in...

07:00
Novo Nordisk announced today that Health Canada has approved ESPEROCT® (Antihemophilic Factor VIII (Recombinant, B-Domain Truncated), PEGylated) for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for: Routine...


11 july 2019

15:05
The NIHC is pleased to announce Lowell Schiller as a keynote speaker at the National Industrial Hemp Council's 2019 Business Summit. The meeting will be held August 12-13, in Portland, Oregon. It will be FDA's first major public presentation since...

09:00
Abbott announced today U.S. Food and Drug Administration (FDA) approval for its new blood and plasma screening Alinitytm s System.  This new solution will bring the latest screening technology to U.S. blood and plasma centers. Alinity s is designed...

04:16
RaySearch has received 510(k) clearance from the FDA in the USA for version 8B of the treatment planning system RayStation®. RayStation 8B was released in December 2018 and includes the first machine learning applications in a treatment planning...


10 july 2019

13:35
Scientists have identified a new ally in the battle against the deadly outbreak of the superbug Candida auris, currently found in more than 20 countries and likely spreading. An independent laboratory study shows that DuraDerm®, an FDA-cleared...

09:00
GE Healthcare, a leader in medical technology and diagnostic and therapeutic imaging, and INSIGHTEC®, a global medical technology innovator of incisionless surgery, today announced FDA approval and CE mark for Exablate Neurotm compatible with the...

08:07
La Roche-Posay is committed to improving access to dermatological care for people with acne, which affects over 50 million Americans. La Roche-Posay announces the launch of Effaclar Adapalene Gel 0.1% Acne Treatment, containing adapalene, a...

07:30
Moleculin Biotech, Inc. ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, today announced it has filed new patents covering the production and...

07:00
Takeda Canada announced today that Health Canada has authorized a chewable tablet of VYVANSE® (lisdexamfetamine dimesylate). This is the first and only chewable treatment for patients with attention deficit/hyperactivity disorder (ADHD) aged six and...

06:00
Azurity Pharmaceuticals, a specialty pharmaceutical company that makes safe, high-quality treatments for patients requiring customized formulations for their care, announced today that the U.S. Food and Drug Administration (FDA) has approved Katerzia...


9 july 2019

14:53
Koios Medical, the leader in ultrasound diagnosis decision support software, announces its second 510(k) clearance from the U.S. Food and Drug Administration (FDA). Koios DS (Decision Support) Breast 2.0 is intended for...

09:19
This week, ConTIPI Medical Ltd. received US Food and Drug Administration (FDA) approval to market its new product, the first of its kind, designed to treat pelvic prolapse in women (such as the uterus and bladder). The...


8 july 2019

15:04
icotec AG, a Swiss company, today announced the VADER®one pedicle screw system was granted U.S. Food and Drug Administration (FDA) 510(k) clearance for both minimally-invasive and open spine surgical procedures. VADER®one, made from icotec's unique...


4 july 2019

11:51
Grifols (MCE:GRF) (MCE:GRF.P) , a leading global producer of plasma-derived medicines, announced today that Xembify®, its new 20% subcutaneous immunoglobulin, has been approved by the U.S. Food and Drug Administration (FDA).  Xembify® is used to...

07:08
BioInvent International AB (BINV) today announced it will receive a $0.5 million milestone payment related to the acceptance by the U.S. Food and Drug Administration of the Investigational New Drug (IND) application for TAK-169, a first-in-class...


3 july 2019

12:51
Today, the U.S. Food and Drug Administration granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have...

08:37
Perrigo Company plc  today announced its product development partner received final approval from the U.S. Food and Drug Administration for its AB-rated Abbreviated New Drug Application ("ANDA") referencing Metrogel-Vaginal® (metronidazole vaginal...


1 july 2019

16:31
Luminex Corporation announced that the company submitted the ARIES® MRSA Assay to the U.S. Food and Drug Administration (FDA) for clearance on Friday, June 28, 2019. The assay is a real-time, quantitative polymerase chain reaction (qPCR)-based, in...

07:00
Palatin Technologies, Inc. , a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today provided a mid-calendar year update...


28 june 2019

12:00
Innovative Health, the leading single-use cardiology medical device reprocessing company, today announced it has received FDA clearance for reprocessing the market-leading PENTARAY® Nav eco High-Density mapping catheter (hereinafter PentaRay), a...


27 june 2019

14:27
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX® (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of patients with newly...

13:30
The U.S. Food and Drug Administration today approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD is...

08:30
DURECT Corporation today announced it has submitted a full response to the Complete Response Letter (CRL) it previously received from U.S. Food and Drug Administration (FDA) related to POSIMIR® (bupivacaine extended-release solution).  The...


26 june 2019

16:36
The U.S. Food and Drug Administration today approved Dupixent (dupilumab) to treat adults with nasal polyps (growths on the inner lining of the sinuses) accompanied by chronic rhinosinusitis (prolonged inflammation of the sinuses and nasal cavity)....

13:29
First biologic medicine for adults with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP) Dupixent significantly reduces nasal polyp size, improves congestion and loss of smell, while reducing the need for surgery and...


25 june 2019

09:00
Dominion Aesthetic Technologies, Inc. today announced that it has received FDA clearance for its body contouring product, eontm FR, which is a non-contact medical device that reduces fat. The laser energy is delivered using a patent-pending powered...

08:00
SweeGen, Inc., a stevia-based sweetener company, announced that the U.S. Food and Drug Administration (FDA) issued a GRAS (Generally Recognized As Safe) No Objection Letter for BESTEVIA® Rebaudioside E ("Reb E") stevia leaf sweetener for use in...


24 june 2019

14:20
QT Vascular Ltd. (the "Company"), is a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease. The United States Food and Drug Administration ("FDA")...

08:00
Micro Medical Solutions (MMS), an innovator in the field of microvascular interventions that improve clinical outcomes and quality of life, announced today that it has received Investigational Device Exemption (IDE) approval from the U.S. Food and...

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