Le Lézard

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

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6 avril 2018

07:33
Impax Laboratories, Inc. , a specialty pharmaceutical company, today announced it has launched a generic version of Estrace® Cream (estradiol vaginal cream, USP, 0.01%).  Impax's manufacturing and development partner, Perrigo Company plc , received...

07:00
Cipher Pharmaceuticals Inc. ("Cipher" or "the Company") today announced it has acquired from Aclaris Therapeutics, Inc. ("Aclaris") the exclusive Canadian rights to distribute and commercialize A-101 40% topical solution ("A-101 40%"). A-101 40% is...


5 avril 2018

10:49
TRELEGY ELLIPTA (furoate de fluticasone, uméclidinium et vilantérol) a été homologué au Canada en tant que premier et seul médicament en inhalation réunissant trois molécules actives pour le traitement d'entretien uniquotidien et prolongé d'une...

10:44
TRELEGY ELLIPTA (fluticasone furoate/umeclidinium/vilanterol), has been approved in Canada as the first and only inhaler product that combines three active molecules for the long-term, once daily, maintenance treatment of chronic obstructive...

08:30
Sanmina Corporation , a leading integrated manufacturing solutions company that makes some of the world's most complex and innovative electronic, optical and mechanical products, today announced that it has received FDA registration at its...


3 avril 2018

09:30
Opsens inc. ("Opsens" ou la "Société")  annonce que l'intégration de la technologie d'Opsens, au sein de la pompe cardiaque Impella CP® ("Impella CP®"), commercialisée par son client Abiomed, Inc. ("Abiomed"), est approuvée par la U.S. Food and Drug...

09:22
Opsens Inc. ("Opsens" or the "Company") announces that the integration of Opsens' technology, within the Impella Cardiac Pump® ("Impella CP®"), marketed by its client Abiomed, Inc. (" Abiomed "), is approved by the US Food and Drug Administration...

07:00
Following the unprecedented Gore REDUCE Clinical Study conclusion that closure of patent foramen ovale (PFO) can prevent recurrent ischemic strokes, W. L. Gore & Associates, Inc. (Gore) has received approval from the U.S. Food and Drug Administration...


2 avril 2018

17:00
Zimmer Biomet Holdings, Inc. , a global leader in musculoskeletal healthcare, today announced the completion of the first surgical case utilizing its Comprehensive® Augmented Baseplate, which received FDA clearance on January 3, 2018. The case was...


29 mars 2018

15:17
Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) for the treatment of adults and children with B-cell precursor acute lymphoblastic...

13:22
The U.S. Food and Drug Administration granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD)....


28 mars 2018

12:00
ASAHI INTECC CO., LTD. announces a Chronic Total Occlusion (CTO) indication for its Corsair, Corsair Pro Microcatheters and its Coronary Guide Wires to include MIRACLEbros series, CONFIANZA series, FIELDER series and Gaia series.  This marks a...

07:00
Global pharmaceutical company Mylan N.V. today announced that it will introduce in the U.S. a third cost-saving HIV combination. The U.S. Food and Drug Administration (FDA) approved Symfitm (efavirenz, lamivudine and tenofovir disoproxil fumarate)...


27 mars 2018

11:00
Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Entecavir tablets USP, 0.5mg and 1mg, a generic version of Baraclude® Tablets by...

08:06
Hologic, Inc. announced today that Clarity HD high-resolution 3Dtm imaging and Intelligent 2Dtm imaging technology have received PMA approval from the U.S. Food and Drug Administration (FDA) and are now available on the 3Dimensions breast...

08:03
The U.S. Food and Drug Administration (FDA) approved Sanofi's Toujeo® (insulin glargine 300 Units/mL) Max SoloStar®, the highest capacity long-acting insulin pen that will be available on the market. The new Max...

08:00
Following its FDA clearance in May 2017, today, Convexity Scientific (Booth #777), a medtech company committed to innovative design and distribution strategies, unveiled its FLYPtm nebulizer, a game-changing handheld nebulizer that is poised to...


26 mars 2018

09:56
Novo Nordisk today announced that the US Food and Drug Administration (FDA) approved updates to the prescribing information (PI) for Tresiba® (insulin degludec injection) 100 U/mL, 200 U/mL to include data from the DEVOTE safety outcomes trial. The...

08:00
DarioHealth Corp. , a leading global digital health company with mobile health and big data solutions, announced today that the United States Food and Drug Administration (FDA) has granted Pre-market Notification (510(k)) clearance for the Company's...

08:00
Bioness, Inc., the leading provider of cutting-edge, clinically supported rehabilitation therapies, today announced that it received clearance from the U.S. Food and Drug Administration (FDA) for the myBionessTM mobile app for use with the...

07:30
Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, today announced that its ORTHO CONNECT V2.0 middleware solution received 510(k) clearance by the U.S. Food and Drug Administration (FDA). ORTHO CONNECT is a comprehensive,...


23 mars 2018

14:00
- First allogeneic stem cell therapy to receive central marketing authorization approval in Europe  - Alofisel offers a new treatment option for patients who do not respond to current available therapies and may be subject to numerous invasive...


22 mars 2018

12:35
Novartis announced today that the US Food and Drug Administration (FDA) expanded the indication for Tasigna® (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive...

10:52
Human Xtensions, a rapidly growing startup company that develops handheld digital solutions for minimally invasive surgery (MIS), announces today that they received FDA 510 (k) clearance for HandXtm. The smart, electromechanically-simplified...

06:00
Respiratory Motion, Inc. reported today that FDA clearance was received for the newest version of its ExSpiron Minute Ventilation (MV) monitoring system on Friday March 16th and announced its plan to launch the new ExSpiron at the Society for...


21 mars 2018

09:04
Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies) today announced that the U.S. Food and Drug Administration (FDA) has approved...

09:00
Longhorn Vaccines and Diagnostics LLC (LHNVD), a private pre-analytical systems and molecular solutions company, has received a clearance from the U.S. Food and Drug Administration (FDA) for PrimeStore® Molecular Transport Medium (MTM).  As the...


20 mars 2018

14:43
The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy....

13:50
Amerigen Pharmaceuticals Limited ("Amerigen") today announced that its Abbreviated New Drug Application ("ANDA") for cyclophosphamide capsules 25mg and 50mg has received final approval from the U.S. Food and Drug Administration. Amerigen believes...

09:01
INVO Bioscience, Inc. , a medical device company granted FDA clearance for the first Intravaginal Culture System, INVOcelltm, today announced that Palm Beach Fertility Center, with locations in Boca Raton and Lake Worth, Florida, is now offering the...

08:50
Therapix Biosciences Ltd. ("Therapix" or the "Company"), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced today that the U.S. Food and...


19 mars 2018

17:20
Seldat Distribution, Inc., announced it has obtained Food and Drug Administration (FDA) certification for its warehouses located in Burlington, NJ, Compton, CA and Fontana, CA. Retailers, manufacturers, wholesalers and many other businesses rely on...


16 mars 2018

08:30
Q BioMed Inc. , a commercial stage biotechnology acceleration development company, and Bio-Nucleonics, licensor of Strontium 89 Chloride, announce submission of a regulatory filing to the FDA for the approval of a new manufacturing facility. Upon...

08:00
Global biotherapeutics leader CSL Behring today announced that the U.S. Food and Drug Administration (FDA) approved Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) as the first and only subcutaneous immunoglobulin (SCIg) for the treatment...


15 mars 2018

11:31
3i Diagnostics announced today that its new technology, called BiospectrixTM, for detecting and identifying bacteria directly from whole blood in less than an hour was granted Breakthrough Device designation by the US FDA. The FDA's Breakthrough...

10:59
UroViu Corporation has announced that its Uro-V single-use diagnostic cystoscopic system has received 510(k) clearance from the US Food and Drug Administration. Additionally, the United States Patent and Trademark Office has issued a patent to UroViu...

10:17
ReddyPort Inc. announced today that it received United States regulatory clearance from the Food and Drug Administration (FDA) for its ReddyPort NIV Access Elbow (www.ReddyPort.com). The ReddyPort Elbow is the first multiple-use access elbow that...

10:00
Royal Philips , a global leader in health technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market ProxiDiagnost N90, its newest premium Digital Radiography-Fluoroscopy (DRF) system. With...

08:00
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for erdafitinib in the treatment of urothelial cancer. Urothelial cancer, most...

07:30
DxNow, Inc., a privately held medical device company, announces receipt of FDA 510(k) clearance of its ZyM?ttm ICSI and ZyM?ttm Multi Sperm Separation Devices. DxNow is developing novel devices for use in assisted reproductive technology (ART)...


14 mars 2018

08:30
Researchers at the Endocrine Oncology Branch of the National Cancer Institute (NCI) reported in the latest edition of the Journal of the National Cancer Institute (JNCI) that they were able to safely and effectively deliver a next-generation...

08:30
Cerapedics, a privately-held orthobiologics company, today announced the company received approval from the U.S. Food and Drug Administration (FDA) to initiate an investigational device exemption (IDE) clinical trial evaluating the safety and...

08:00
Amneal Pharmaceuticals has received FDA approval for Erythromycin Tablets USP, 250 mg and 500 mg strengths.  The Amneal product is a therapeutic equivalent for the reference listed drug (RLD) Erythromycin Tablets from Arbor Pharmaceuticals and is the...


13 mars 2018

07:30
As blood resources nationwide are being closely examined to prevent the risk of transmitted infections during blood transfusions, one Wisconsin blood bank is proud to announce a new technology that will help to further its commitment to ensuring the...


12 mars 2018

08:00
Lipocine Inc. , a specialty pharmaceutical company, today announced financial results for the fourth quarter and fiscal year ended December 31, 2017. Fourth Quarter and Recent Corporate Highlights On January 10, 2018,...


9 mars 2018

12:45
MiMedx Group, Inc. , a leading developer and marketer of regenerative and therapeutic biologics, today announced that the U.S. Food and Drug Administration (FDA) has granted MiMedx's micronized amniotic tissue, AmnioFix® Injectable, the Regenerative...

07:00
Yesterday, the FDA approved the conduct of a pivotal clinical trial using a new technology to treat overactive bladder. The technology, developed and manufactured by Valencia Technologies, is called eCoinTM.  It works by sending out electrical...


8 mars 2018

10:41
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its new hematology testing solution, the cobas m 511 integrated hematology analyzer, has received 510(k) clearance  from the U.S. Food and Drug Administration (FDA)....


7 mars 2018

18:32
Veloxis Pharmaceuticals A/S announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food & Drug Administration (FDA) seeking a new indication for ENVARSUS XR (tacrolimus extended-release tablets) for the...

16:02
Protagonist Therapeutics, Inc. today reported its financial results for the fourth quarter and full year ended December 31, 2017 and provided an update on the company's recent achievements. "2017 was a very successful...

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