Le Lézard

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

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6 octobre 2017

16:59
The U.S. Food and Drug Administration today approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea. The Remed? System is an implantable device that stimulates a nerve located in the chest that...

08:07
The injury and surgery recovery technology leader, Game Ready®, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary orthopedic rehabilitation device, the Med4 Elitetm....


5 octobre 2017

17:39
The U.S. Food and Drug Administration today approved the cobas Zika test, a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from...

16:01
Hologic, Inc. announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Panther Fusion® Flu A/B/RSV assay running on the new Panther Fusion® system.  The Panther Fusion is available as...

11:57
McGuff Pharmaceuticals, Inc., a wholly owned subsidiary of McGuff Company, Inc. announces the United States Food and Drug Administration's New Drug Approval (NDA) of Ascor® (Ascorbic Acid Injection USP). Ascor® is...

07:00
Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Xpress Strep A. The test provides rapid, accurate, and reliable molecular detection of Streptococcus pyogenes (Group A...

07:00
Neurocrine Biosciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved an 80 mg INGREZZA® (valbenazine) capsule strength to be used for the treatment of adults with tardive dyskinesia (TD). INGREZZA, a novel,...


4 octobre 2017

17:16
Solta Medical, a division of Valeant Pharmaceuticals North America LLC, announced today that its Thermage FLXtm System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to non-invasively smooth skin on the face, eyes, and...

16:16
Peerbridge Health Inc., a Health IT company, announced today that its first product, the Peerbridge Cortm System -- a wireless electrocardiogram (ECG) monitor -- has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The...

13:00
FDA issues final Guidance for Industry, transferring regulatory authority to EPA  Following new Guidance issued by the U.S. Food and Drug Administration's Center for Veterinary Medicine (FDA-CVM), regulatory jurisdiction for Oxitec's Friendlytm...

10:14
Intellijoint Surgical®, a medical technology company, is pleased to announce that it has received the approval of the CE Mark (Conformité Européenne) for its intellijoint HIP® System in Europe. A 3D Mini-Optical Navigation System, intellijoint HIP®...

09:54
On September 29, 2017, the U.S. Food and Drug Administration (FDA) proposed an extension of the compliance dates for the final rules mandating changes to food, beverage, and supplement labeling.  The extension would provide large food businesses...

09:00
Applied Spectral Imaging (ASI), a global leader in computer-assisted biomedical imaging, announced today the launch of PathFusiontm and HiPath Protm, innovative Brightfield and FISH imaging & analysis solutions for pathology. ASI will unveil the new...

08:00
Solta Medical, a division of Valeant Pharmaceuticals International, Inc. ("Valeant"), announced today that its Thermage FLXtm System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to non-invasively smooth skin on the...

04:00
CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces it has secured new equity funding. Existing investors, Archangel Investors and the Scottish Investment Bank...


3 octobre 2017

20:08
Mylan N.V. today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, an AP-rated, substitutable generic...

09:00
DiscGenics, Inc., a clinical stage regenerative medicine company focused on developing regenerative therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, is pleased to announce that it has been...

08:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced immediate plans to initiate screening of blood samples with the cobas® Babesia test under an Investigational New Drug Application protocol. The cobas® Babesia test for use with the cobas® 6800/8800...

07:31
Today Allergan plc announced the FDA approval of BOTOX® Cosmetic for its third indication, the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. This approval makes the...

07:00
Carrot Inc. announced today that its Carbon Monoxide Breath Sensor System has been cleared by the U.S. Food and Drug Administration (FDA) for over-the-counter commercial use in smoking cessation programs. The Bluetooth-enabled mobile device, which...


2 octobre 2017

16:05
QIAGEN today announced that its manufacturing and supply chain for consumables and other products for forensic and human identity testing has been certified by Bureau Veritas, a leading inspection agency, as meeting the latest international...

12:39
Mylan N.V. today announced the U.S. launch of Caspofungin Acetate for Injection, one of the first generic versions of Merck's Cancidas®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug...

08:00
Allergan plc , a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and avibactam) for priority review. The sNDA filing...

07:00
Alere Inc. , a global leader in rapid diagnostics, today announced that its Aleretm i Influenza A & B 2 test has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for the detection of influenza A and B infection in...

06:56
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 Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg, the therapeutic...


29 septembre 2017

16:59
Mylan N.V. today announced the U.S. launch of Imatinib Mesylate Tablets, 100 mg and 400 mg, a generic version of Novartis's Gleevec® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug...

11:03
Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved Fiasp® (insulin aspart injection) 100 Units/mL, a fast-acting mealtime insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes.1...


28 septembre 2017

14:25
The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has...

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 FDA 510(k) clearance for the FLXfittm15, enhancing the already...

07:00
Impopharma Inc. ("Impopharma") today announced that it has entered into an asset purchase, license, and commercialization agreement with Breckenridge Pharmaceutical, Inc. ("Breckenridge"). Under terms of the agreement, Breckenridge has acquired the...


27 septembre 2017

18:41
- REVOLUTIONARY SYSTEM TO REPLACE BLOOD GLUCOSE MONITORING, ELIMINATING THE NEED FOR ROUTINE FINGER STICKS(1) AND FINGER STICK CALIBRATION - EASY-TO-USE(2), LONGER LASTING AND LESS BULKY(3) THAN OTHER CONTINUOUS GLUCOSE MONITORS AVAILABLE IN U.S....

17:42
Abbott  today announced that the U.S. Food and Drug Administration (FDA) has approved the FreeStyle® Libre Flash Glucose Monitoring System as a replacement1 for blood glucose monitoring (BGM) for adults with diabetes in the U.S. This revolutionary...

17:24
The U.S. Food and Drug Administration today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using...

08:00
Hologic, Inc.  announced today that the U.S. Food and Drug Administration (FDA) has granted an expanded FDA 510(k) clearance for Cynosure's non-invasive body contouring product, SculpSure®. The state-of-the-art body contouring laser treatment is now...

07:00
Check-Cap Ltd. (the "Company" or "Check-Cap") , a clinical-stage medical diagnostics company engaged in the development of C-Scan®, an ingestible capsule for preparation-free, colorectal cancer screening, today announced that it has filed for the CE...

06:51
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 Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg and 10 mg/325 mg, the...

06:00
Fotona, based in the U.S. and Europe, has received FDA clearance for its new StarWalker® MaQX Q-Switched laser system for treating tattoos, pigmented and vascular lesions, acne and scar revision and even permanent hair reduction. The Verde 532 mode...

06:00
Pall Medical, a division of Pall Corporation ? a global leader in filtration, separation and purification ? is pleased to announce that its QPoint® Water Filter Capsules have received FDA 510(k) clearance as a Class ll Medical Device.  The...


26 septembre 2017

14:23
Eisai Inc. today announced the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for lenvatinib (marketed as Lenvima®) for the potential use in the first-line treatment of patients with...

08:35
Mortise Medical, a start-up medical device company focused on advanced soft tissue repair systems for ankle injuries, announces that it has recently received FDA 510(k) clearance for its innovative LigaMetricstm Suture Anchor System.   The Mortise...

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 Dexmethylphenidate Hydrochloride Tablets, 2.5 mg, 5 mg, and 10 mg, the therapeutic...


25 septembre 2017

08:00
Atox Bio today announced that it has been awarded the next option on a performance-based contract with the Biomedical Advanced Research and Development Authority (BARDA) for the development of Reltecimod in patients with Necrotizing Soft Tissue...

08:00
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) approved TAGITOL V (barium sulfate) oral suspension...

07:00
Boston Scientific has launched the Resonatetm family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems featuring the HeartLogictm Heart Failure Diagnostic to help physicians improve...

06:30
Prometic...

06:30
Prometic Life Sciences Inc. (Prometic) today announced that its oral anti-fibrotic lead...

06:30
Ocugen, Inc., a clinical stage biopharmaceutical company developing novel treatments for sight-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application for OCU310...


22 septembre 2017

08:00
Abbott today announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for one of Abbott's most widely-used implantable cardioverter defibrillators (ICD) and associated high voltage leads. The...


21 septembre 2017

09:29
Perrigo Company plc today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing Exalgo® 32mg extended release tablets (hydromorphone HCl). The company...

09:00
CEFALY Technology announces today that on Friday, September 15th, the U.S. Food and Drug Administration (FDA) released the use of a new Cefaly® medical device for the acute treatment of migraine, with or without aura, in patients 18 years of age or...

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