Le Lézard

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

22 juin 2017

06:53
Lannett Company, Inc. today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Hydrocodone Bitartrate and Acetaminophen Tablets USP, 5 mg/300 mg, 7.5 mg/300 mg and...


21 juin 2017

11:22
Beckman Coulter Diagnostics along with partner Diazyme Laboratories announces FDA clearance of a new procalcitonin (PCT) assay, an important tool for the management of bacterial infections and sepsis. Sepsis is the...

10:34
Additive Orthopaedics, LLC., an orthopaedic device company, today announced that is has received FDA 510(k) clearance for its 3D printed minimally-invasive, intramedullary Bunion Correction System, to address alignment and stabilization of bunions. ...

09:00
Israeli biotechnology company Kadimastem announced today that it had received approval from the IRB (Helsinki Committee) of the Hadassah Ein Kerem Hospital for the phase 1/2a clinical trial in ALS patients using the cell therapy product developed by...


20 juin 2017

18:48
Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) has approved MYDAYIS[TM] (mixed salts of a single-entity amphetamine product), a once-daily treatment comprised of three different types of...

09:06
Egalet Corporation ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain and other conditions, today announced that it received a complete response letter...

08:30
Intezyne Technologies, a clinical-stage biopharmaceutical company developing novel anti-cancer therapies, announced that that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted Orphan Drug Designation...

06:59
BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced that its new line of Snowden-Pencertm 3.0mm laparoscopic ergonomic take-apart instruments received U.S. Food and Drug Administration (FDA) 510(k)...


19 juin 2017

09:00
Amgen today announced that the U.S. Food and Drug Administration (FDA) has accepted the XGEVA® (denosumab) supplemental Biologics License Application (sBLA) that seeks to expand the currently approved indication for the prevention of fractures and...

07:07
Spine surgery offers a new lease on life for patients experiencing back pain and discomfort. With an estimated 450,000+ lumbar fusions performed each year in the United States, surgeons are familiar with Meditech Spine's Talos® Lumbar Peek devices as...

06:53
Lannett Company, Inc. today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Niacin Extended-Release Tablets USP, 500 mg and 1000 mg, the therapeutic equivalent...


16 juin 2017

14:15
Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the immunotherapy DARZALEX® (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who...


15 juin 2017

12:01
It is incumbent upon FDA to ensure that we have the right policies in place to promote and encourage safe and effective innovation that can benefit consumers, and adopt regulatory approaches to enable the efficient development of these technologies....

08:00
Hologic, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for Cynosure's non-invasive body contouring product, SculpSure, to treat the back and inner and outer thighs. The SculpSure treatment is...


14 juin 2017

09:53
TSO3 inc. , une innovatrice dans le domaine de la stérilisation des instruments médicaux en milieu hospitalier, a annoncé aujourd'hui que la Société projette actuellement d'obtenir auprès des autorités américaines l'autorisation 510(k) pour son...

09:47
TSO3 Inc. , an innovator in sterilization technology for medical devices in healthcare settings, today announced that the Company now plans to seek 510(k) clearance for its STERIZONE® VP4 Sterilizer from US regulators for the terminal sterilization...


13 juin 2017

14:19
The International Dairy Foods Association appreciates the Food and Drug Administration's (FDA) announced intention to extend the compliance dates for the new Nutrition Facts label and Serving Size rules. "On behalf of our members, we thank the Food...

10:00
Interson announced today they have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market their SiMPLi Series ultrasound array probes for medical applications.  Interson has been the market leader in open-architecture...

09:00
TECHLAB,® Inc., a leading developer and manufacturer of rapid, non-invasive diagnostic tests for gastrointestinal disease, today announced that it received U.S. Food and Drug Administration (FDA) clearance for E. HISTOLYTICA QUIK CHEKtm test.  E....


12 juin 2017

04:05
BioMarin Pharmaceutical Inc. announced today The Food and Drug Administration (FDA) has approved a bulk biologics manufacturing plant, located in Shanbally, Cork, Ireland for production of the formulated bulk substance (N-acetylgalactosamine...

01:30
EuroMedLab -- A new immunoassay for the specific detection of buprenorphine and its three major metabolites -- buprenorphine-?-D-glucuronide, norbuprenorphine, and norbuprenorphine-?-D-glucuronide  -- has received 510(k) clearance from the U.S. Food...


8 juin 2017

16:30
OncoSec Medical Incorporated ("OncoSec") , a company developing DNA-based intratumoral cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for pIL-12, otherwise known as...

09:00
Thornhill Medical, has received notification from the US FDA that the MOVES® SLCtm Portable Emergency Life Support System has received 510K clearance. This approval expands the capabilities of the current MOVES® SLCtm system, including Pediatric...

09:00
QIAGEN N.V. today announced the U.S. regulatory approval of QuantiFERON®-TB Gold Plus (QFT®-Plus) the fourth generation of the market leading blood test for detecting latent tuberculosis (TB) infection. The approval by the U.S. Food and Drug...


7 juin 2017

15:17
MedNet Solutions, an innovative cloud-based eClinical technology company that supports the entire spectrum of clinical research, is pleased to announce they will preview the latest release of iMedNettm, its agile, efficient, and effective eClinical...

11:30
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...

09:00
Amgen and Allergan plc. today announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the Biologics License Application (BLA) for ABP 215, a biosimilar candidate to Avastin®...

08:00
Hologic, Inc. announced today that the Geniustm 3D Mammographytm exam is now the only mammogram that is FDA-approved as superior to standard 2D mammography for routine breast cancer screening of women with dense breasts.1 The Genius exam has been...

08:00
On behalf of patients living with lung cancer and their loved ones, the Canadian Cancer Survivor Network (CCSN) and Lung Cancer Canada (LCC) are calling on government and industry to help accelerate negotiations for public funding of Health Canada...

06:00
Eko Devices ("Eko"), the leader in mobile acoustic cardiac monitoring tools, has received FDA clearance to market its latest innovation, DUO ? a combined digital stethoscope and electrocardiogram (ECG). The portable cardiac device was inspired by...


6 juin 2017

08:30
Uncontrolled bleeding during surgery can adversely affect patient outcomes, hospital costs and resources.1-9 Primary methods of hemostasis alone may be ineffective or impractical,10 and it is increasingly important that health care professionals are...

08:00
PTC Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative scheduling of a Peripheral and Central Nervous Systems Drugs Advisory Committee meeting on September 28, 2017 to review...

05:30
Announcement marks company's official entry into the US market  OrbusNeich, a global company specializing in the provision of life-changing vascular solutions, has announced the launch of its world-renowned Sapphire PTCA balloon dilatation catheters...

05:30
OrbusNeich, a global company specializing in the provision of life-changing vascular solutions, has announced the launch of its world-renowned Sapphire PTCA balloon dilatation catheters following their recent 510k clearance by the FDA: the Sapphiretm...

05:30
Cette annonce marque l'entrée officielle de l'entreprise sur le marché des États-Unis    OrbusNeich, une entreprise mondiale spécialisée dans la fourniture de solutions vasculaires pour l'amélioration de la vie, a annoncé le lancement de ses...

02:00
QIAGEN today announced it has received premarket approval from the U.S. Food and Drug Administration (FDA) for its automated artus® CMV QS-RGQ MDx kit for use on QIAGEN's QIAsymphony platform, providing fast, reproducible, high-quality test results...


5 juin 2017

16:30
Edwards Lifesciences Corporation , the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it has received U.S. Food and Drug Administration (FDA) approval for aortic and mitral...

15:32
The U.S. Food and Drug Administration today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose...

10:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA approval for the cobas® CMV (cytomegalovirus) test for use on the fully automated cobas® 6800 and cobas® 8800 Systems. Health care professionals use the CMV test to assess...

09:00
Expanding Orthopedics Inc. (EOI), a privately-held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced CE mark of the FLXfittm15, enhancing the already successful FLXfittm...

07:30
Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today the appointment of Nobel Prize Laureate Professor Roger Kornberg and immune oncology expert and recently retired Novartis...


2 juin 2017

07:30
Mylan N.V. today announced the U.S. launch of Zoledronic Acid Injection, 5 mg/100 mL Single Dose Vial, a generic version of Novartis' Reclast® Injection. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its...

07:00
Personal Genome Diagnostics Inc. (PGDx), a pioneer in cancer genomic testing, today highlighted its patent-pending microsatellite instability (MSI) testing technology following the U.S. Food and Drug Administration's (FDA) accelerated approval of...


1 juin 2017

14:24
Nexus Pharmaceuticals announced today the immediate availability in the United States of Sodium Nitroprusside Injection. Nexus Pharmaceuticals' Sodium Nitroprusside Injection is available as a single dose vial containing 50 mg per 2mL (25mg/mL) and...

10:05
More than 1.6 million people die globally from lung cancer each year.1 ALK ? anaplastic lymphoma kinase ? is an important biomarker found in non-small cell lung cancer (NSCLC). Its detection and inhibition can help shrink tumors in some ALK-positive...

09:00
GenePOC announces it received 510(k) clearance from the US Food and Drug Administration to market its first molecular assay to detect Group B Streptococcus and for the revogene molecular diagnostics instrument.  GenePOC, Inc. (GenePOC) a member of...

09:00
GenePOC annonce l'homologation 510(k) de la part de la Food and Drug Administration des États-Unis pour la commercialisation de son premier test bactériologique, le GenePOC GBS LB, ainsi que l'instrument de diagnostic moléculaire, le revogene. ...

07:00
- Genentech has submitted all three solid tumor trials planned underits cancer immunotherapy collaboration with BioLineRx -  - Studies will investigate the combination in pancreatic cancer, gastric cancer and non-small cell lung cancer...


31 mai 2017

17:32
Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for REBINYN® (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia...

16:05
Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its recently submitted New Drug Application (NDA) for  VYXEOStm (cytarabine and daunorubicin) liposome injection,...