Le Lézard

Communiqués de presse par sujet : Approbation de la FDA (Food and Drug Administration)

27 décembre 2016

07:00
New FDA-approved indications for ADYNOVATE provides more hemophilia A patients access to proven prophylaxis with a simple, twice-weekly dosing schedule   Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug...


24 décembre 2016

15:01
Within a week of Christmas day, a drug called nusinersen will be in the hands of doctors across the nation, who will use it, most urgently, to treat young children with a severe and potentially fatal illness called spinal muscular atrophy (SMA)....


23 décembre 2016

16:35
The U.S. Food and Drug Administration today approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement....

00:31
BioNet-Asia announced today that its first recombinant acellular Pertussis booster vaccine containing a proprietary genetically-detoxified Pertussis Toxin (PTgen), received Marketing Authorization Approval (MAA) from the Thai Food and Drug...


22 décembre 2016

18:00
Alcon, the global leader in eye care and a division of Novartis, has received approval from the US Food and Drug Administration (FDA) for its AcrySof® IQ ReSTOR® +3.0D Multifocal Toric Intraocular Lens (IOL). The new IOL is designed to address...


21 décembre 2016

23:27
Highlights AirXpanders has received U.S. Food and Drug Administration (FDA) de novo clearance for AeroForm®, opening the door for the device to be launched in the United States Commercial launch in the U.S. to commence January 2017 U.S. sales...

10:39
Une étude pivot démarrera en 2017 en vue d'obtenir une autorisation de pré-commercialisation  CartiHeal (2009) Ltd., développeur d'un implant acellulaire prêt à l'emploi destiné à une utilisation en cas de défauts cartilagineux et de lésions...

05:30
Animas Corporation, qui fait partie de Johnson & Johnson Diabetes Care Companies (JJDCC), a annoncé aujourd'hui avoir reçu l'approbation de la Food and Drug Administration (FDA) des États-Unis et l'autorisation de Santé Canada pour la...


20 décembre 2016

14:39
The U.S. Food and Drug Administration today expanded the approved use of Dexcom's G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years...

13:14
Elusys Therapeutics, Inc. (Elusys) today announced that the company published data and analyses used to determine the intravenous adult human dose for ANTHIM® (obiltoxaximab) Injection, its treatment for inhalational anthrax.  The animal to human...

11:16
PMA Pivotal Study will start during 2017 CartiHeal (2009) Ltd., developer of a cell-free, off-the-shelf implant for use in cartilage and osteochondral defects, announced today the FDA approval of the Investigational Device Exemption (IDE)...

09:07
Animas Corporation, part of the Johnson & Johnson Diabetes Care Companies (JJDCC), announced today that it has received U.S. Food and Drug Administration (FDA) approval, and Health Canada's authorization for the sale of the OneTouch Vibetm Plus...

08:58
Perrigo Company plc today announced it has received approvals from the U.S. Food and Drug Administration for Abbreviated New Drug Applications referencing GlaxoSmithKline's Nicorette® White Ice Mint® Gum (nicotine polacrilex gum 2 mg and 4 mg)....

08:00
Astellas Pharma Inc. (President and CEO: Yoshihiko Hatanaka, "Astellas") and Immunomic Therapeutics, Inc. (Founder & CEO: William Hearl, Ph.D., "Immunomic Therapeutics") today announced that the U.S. Food and Drug Administration (FDA) has granted...


19 décembre 2016

14:00
Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL), a once-daily, long-acting basal insulin, to...

12:48
Americans who don't want to see the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) prevail in the agencies' "war" against the coffee-like herb kratom are being urged to sign a petition to President-Elect Donald Trump...

11:21
The U.S. Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. Rubraca is approved for women with advanced ovarian cancer who have been treated with two or more...

10:17
Instrumentation Laboratory (IL) today announced the 510(k) clearance of their latest innovation, the GEM Premier 5000 in vitro diagnostic (IVD) analyzer with Intelligent Quality Management 2 (iQM®2) by the US Food and Drug Administration (FDA)....

07:00
Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for Xpert® MRSA NxG, the next generation methicillin-resistant Staphylococcus aureus (MRSA) infection control test from the leader in...

06:56
Lannett Company, Inc. today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Supplemental New Drug Application (sNDA) for Morphine Sulfate Oral Solution CII, color and flavor added, 20 mg/mL.  According to...

02:06
BrainStorm Cell Therapeutics Inc. , a leading developer of adult stem cell technologies for neurodegenerative diseases, today provided a corporate update and announced its clinical development objectives for 2017. 2017...


16 décembre 2016

09:48
QT Vascular Ltd., (the "Company" or "QT Vascular", and together with its subsidiaries, the "Group"), is a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of...

06:48
Grünenthal receives Breakthrough Therapy Designation from U.S. FDA for neridronic acid for the treatment of complex regional pain syndrome (CRPS), a debilitating orphan disease with high medical need  Neridronic acid is the first...


15 décembre 2016

07:00
EnteroMedics Inc. , the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced an assessment of real-world, clinical practice weight loss data in patients...


14 décembre 2016

13:32
The U.S. Food and Drug Administration today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older.  Atopic dermatitis, a chronic inflammatory skin disease, is often...

12:00
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to nintedanib for the treatment of mesothelioma. Orphan drug designation is granted by the FDA to investigational compounds...

09:38
Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a supplemental Biologics License Application (sBLA) for myBETAapptm and the BETACONNECTtm Navigator.  MyBETAapp is intended for patients taking...

09:30
Ability Pharmaceuticals, a drug development biopharmaceutical company specialized in oncology, announced today that it has received from the US Food and Drug Administration (FDA), orphan-drug designation (ODD) for ABTL0812, for the treatment of...

07:00
Janssen Inc. a annoncé aujourd'hui que Santé Canada a émis un avis de conformité (AC) pour STELARA® (ustekinumab) indiqué dans le traitement de la...

07:00
Janssen Inc. announced today that Health Canada has issued a Notice of Compliance (NOC) for STELARA® (ustekinumab) indicated for the treatment of adult patients with moderately to severely...


13 décembre 2016

17:54
The U.S. Food and Drug Administration today approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci is the first FDA-approved...


12 décembre 2016

15:28
The U.S. Food and Drug Administration (FDA) has approved Synjardy® XR (empagliflozin and metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. When used along with diet and exercise, SYNJARDY XR is indicated to improve...

07:55
Galderma, a global leader focused on medical solutions in skin health, announced today it has received U.S. Food and Drug Administration (FDA) approval of two new products for the treatment of nasolabial folds (NLF) or "laugh lines," in patients over...


9 décembre 2016

09:00
Portage Biotech Inc. ("Portage" or "the Company") , is pleased to announce that Biohaven has issued today the following press release: New Haven, Connecticut (PRWEB) Dec 9, 2016 - Biohaven Pharmaceutical Holding Company Ltd. (the "Company" or...


8 décembre 2016

13:17
Actuated Medical Inc. (AMI) received U.S. Food and Drug Administration (FDA) Clearance on 3 additional TubeClear System Clearing Stem Models. This FDA clearance enables the TubeClear System to operate in feeding tubes as narrow as 6 French (2mm),...

08:20
Mederi Therapeutics Inc. a annoncé l'approbation réglementaire par la CFDA et le lancement en Chine de la thérapie Stretta, un traitement non-chirurgical contre le reflux gastro-oesophagien chronique (RGO). Photo -...

08:00
LEVL, an exciting new health and wellness device announced today that it is now classified as a FDA Class I medical device. This is a critical next step for the innovative device that will change the fat loss conversation with just one breath....

07:11
Mederi Therapeutics Inc. has announced regulatory approval by CFDA and product launch in China for Stretta Therapy, a non-surgical treatment for chronic gastroesophageal reflux disease (GERD). Photo -...

07:00
Exact Imaging (www.exactimaging.com), the world's leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, announced it has received FDA 510(k) Clearance for its ExactVutm micro-ultrasound...


7 décembre 2016

09:21
Kitov Pharmaceuticals Holdings Ltd. , an innovative biopharmaceutical company focused on late stage drug development, announced today that its lead drug candidate KIT-302 met the U.S. Food and Drug Administration's (FDA) standards for establishing...

07:00
B. Braun Melsungen AG ("B. Braun"), The Trendlines Group Ltd. (SGX: 42T, OTCQX: TRNLY) ("Trendlines") and Gordian Surgical Ltd. ("Gordian") jointly announced B. Braun's lead position in Gordian's recent financing round of US$2.25 million; Gordian...


6 décembre 2016

10:17
The Amyloidosis Research Consortium (ARC) today announced the submission of a draft guidance for industry on developing drugs for AL amyloidosis to the Food and Drug Administration (FDA), to improve the design of clinical trials and accelerate the...

10:00
La société One Drop a annoncé aujourd'hui qu'elle avait reçu l'autorisation 510(k) de la U.S. Food and Drug Administration (FDA) et l'approbation de marquage de...

10:00
One Drop today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Conformité Européene (CE) mark approval for One Drop | Chrome, a beautiful blood glucose monitoring...


5 décembre 2016

08:00
The U.S. Food and Drug Administration (FDA) approved a new indication for Jardiance® (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. JARDIANCE is the first type...

07:00
CASI Pharmaceuticals, Inc. , a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announced today that China's Food and Drug Administration (CFDA) has accepted for review the Company's...


2 décembre 2016

13:08
The U.S. Food and Drug Administration today approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease. "Cardiovascular disease is a...


1 décembre 2016

16:18
Nanowear, an early stage developer of cloth-based diagnostic monitoring nanosensor technology, today announced that it has received FDA Class II 510(k) clearance for its first product, SimplECGtm, a remote cardiac monitoring undergarment. SimplECGtm...

13:50
Egalet Corporation ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, today announced that the company has submitted to the...

11:23
Helsinn Integrative Care, unité commerciale d'Helsinn spécialisée dans les produits non pharmaceutiques de soins de support en oncologie fondés sur des données factuelles, annonce aujourd'hui avoir obtenu de la FDA aux États-Unis l'autorisation...