Le Lézard

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

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Aujourd'hui

14:46
SILVER SPRING, Md., Nov. 17, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform. The remote...

08:39
Insulia détient désormais un agrément pour le titrage de toutes les marques d'insuline basale CAMBRIDGE, Massachusetts, le 17 novembre 2017 /PRNewswire/ -- Aujourdhui, Voluntis a annoncé qu'Insulia®, son logiciel compagnon pour les personnes...


16 novembre 2017

16:02
SILVER SPRING, Md., Nov. 16, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Sutent (sunitinib malate) for the adjuvant treatment of adult patients who are at a high risk of kidney cancer (renal cell carcinoma)...

14:21
JERSEY CITY, N.J., Nov. 16, 2017 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that more than 1,000 people with amyotrophic lateral sclerosis (ALS) have been treated with RADICAVA® (edaravone) since it became available...

08:45
AUSTIN, Texas, Nov. 16, 2017 /PRNewswire/ -- Vermillion (NASDAQ: VRML) announced today the acceptance and publication of a novel paper, "Economic Impact of Increased Utilization of Multivariate Assay Testing to Guide the Treatment of Ovarian Cancer:...

08:00
RANCHO SANTA MARGARITA, Calif. and WESTCHESTER, Ill., Nov. 16, 2017 /PRNewswire/ -- SweeGen, Inc., a nature-based sweetener company, and Ingredion Incorporated, a leading global provider of ingredient solutions to diversified industries, jointly...

08:00
Insulia now cleared for titration of all brands of basal insulin CAMBRIDGE, Massachusetts, Nov. 16, 2017 /PRNewswire/ -- Today, Voluntis announced that Insulia®, its digital companion for people with Type 2 diabetes, has received FDA clearance and...

07:15
QUÉBEC et MYRTLE BEACH, SC, le 16 nov. 2017 /CNW Telbec/ - TSO3 inc. (la « Société ») (TSX: TOS), une société innovatrice du domaine de la technologie de stérilisation des instruments médicaux en milieu hospitalier, a annoncé aujourd'hui qu'elle a...

07:15
QUEBEC CITY and MYRTLE BEACH, SC, Nov. 16, 2017 /PRNewswire/ - TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, announced today that it has responded to the recent request for additional...


15 novembre 2017

21:36
ROCKVILLE, Md., Nov. 15, 2017 /PRNewswire-USNewswire/ -- Ascentage Pharma, a global clinical-stage biopharmaceutical company dedicated to developing apoptosis-targeted therapies, today announced that the U.S. Food and Drug Administration (FDA) has...

12:08
SILVER SPRING, Md., Nov. 15, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Mepsevii (vestronidase alfa-vjbk) to treat pediatric and adult patients with an inherited metabolic condition called...

11:31
SILVER SPRING, Md., Nov. 15, 2017 /PRNewswire-USNewswire/ -- Today, the U.S. Food and Drug Administration granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal....

10:36
DUBLIN, Nov. 15, 2017 /PRNewswire/ -- Noden Pharma DAC, a global specialty pharmaceutical company that is focused on acquiring prescription medicines across a broad range of therapeutic areas, announced today the approval by the U.S. Food and Drug...

08:00
LOWELL, Mass., Nov. 15, 2017 /PRNewswire/ -- Alcyone Lifesciences, Inc., announced that the U.S. Food and Drug Administration (FDA) cleared the Alivio Ventricular Catheter & Flusher System (Alivio System) for the treatment of hydrocephalus. This...


14 novembre 2017

19:02
WILMINGTON, Del., Nov. 14, 2017 /PRNewswire/ -- AstraZeneca (NYSE: AZN) and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has approved FASENRAtm (benralizumab) for the...

13:00
 -- The VENTANA MMR IHC Panel1 helps differentiate between sporadic colorectal cancer and probable Lynch syndrome, a hereditary form of colorectal cancer  -- The National Comprehensive Cancer Network recommends universal screening of all newly...

07:50
ATLANTA, Nov. 14, 2017 /PRNewswire/ -- MedShape, Inc., the industry leader in orthopaedic devices using advanced functional materials, announced today that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the...

00:16
TOKYO and REDWOOD CITY, Calif., Nov. 14, 2017 /PRNewswire/ -- Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital Health (Proteus) today announce that the United States Food and Drug Administration (FDA) has granted the first approval of a...


13 novembre 2017

19:17
SILVER SPRING, Md., Nov. 13, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved the first drug in the U.S. with a digital ingestion tracking system. Abilify MyCite (aripiprazole tablets with sensor) has an ingestible...

08:15
DARMSTADT, Germany, November 13, 2017 /PRNewswire/ -- New pen is easy-to-learn and easy-to-use, supporting the one in six couples affected by infertility in the U.S.[1]  Insights of patients, nurses and doctors helped to evolve the...

08:00
ROCKLAND, Mass., Nov. 13, 2017 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, received approval for a redesigned version of GONAL-f® RFF* Redi-ject® (follitropin alfa injection)...

07:35
DUBLIN, Nov. 13, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for VRAYLARtm (cariprazine) for the maintenance treatment of...


9 novembre 2017

09:00
CHICAGO, Nov. 9, 2017 /PRNewswire-USNewswire/ -- Northwestern Medicine's urology department is excited to announce a minimally invasive treatment option for men with enlarged prostates. The UroLift® System is the first permanent implant to treat...

08:30
KALAMAZOO, Michigan, USA, Nov. 9, 2017 /PRNewswire/ -- Stryker Corporation announced today that the U.S. Food and Drug Administration has approved the Neuroform Atlastm Stent System for marketing under a humanitarian device exemption (HDE).  The...


8 novembre 2017

17:34
BALTIMORE, Nov. 8, 2017 /PRNewswire/ -- DT MedTech, LLC (DTM) today announced that the Hintermann Series H2tm Total Ankle Replacement System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA)....


7 novembre 2017

10:58
TUCSON, Ariz., Nov. 7, 2017 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced it has obtained US Food and Drug Administration (FDA) approval for the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive...

06:00
CALGARY, Nov. 7, 2017 /CNW/ - Kent Imaging Inc., a leading innovator in multispectral oxygenation imaging, announced today that their handheld KD203 is a licensed medical device with Health Canada. Kent's device is also cleared with the U.S. Food and...


6 novembre 2017

11:40
SILVER SPRING, Md., Nov. 6, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with Erdheim-Chester Disease (ECD), a rare...

08:00
NEW YORK, Nov. 6, 2017 /PRNewswire/ -- Artemis Therapeutics, Inc. (OTCQB: ATMS), ("Artemis" or the "Company"), a pharmaceutical company developing new therapies for the treatment of life-threatening infectious diseases, today announced that the...

08:00
ATLANTA and BRUSSELS, Nov. 6, 2017 /PRNewswire/ --  VIMPAT® (lacosamide) CV oral formulations are approved as a monotherapy or adjunctive therapy in patients four years of age and older with partial-onset seizures (POS)1 Pediatric epilepsy is...

07:59
Approval granted based on promising tumour response rate and duration of response MISSISSAUGA, ON, Nov. 6, 2017 /CNW/ - AstraZeneca Canada today announced that Health Canada has approved Imfinzi® (durvalumab) for the treatment of advanced bladder...

07:59
Approbation accordée en raison de données prometteuses concernant le taux de réponse tumorale et la durée de la réponse MISSISSAUGA, ON, le 6 nov. 2017 /CNW/ - AstraZeneca Canada a annoncé aujourd'hui que Santé Canada avait approuvé l'emploi...

07:00
NASDAQ, TSX: NVCN VANCOUVER, Nov. 6, 2017 /CNW/ - Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN) announced that it has received approval of the U.S. Food and Drug Administration ("FDA") to initiate the COSIRA-II IDE pivotal clinical...


2 novembre 2017

22:10
SHANGHAI et LYON, France, 3 novembre 2017 /PRNewswire/ -- La société de technologies médicales EYE TECH CARE, qui a reçu plusieurs prix d'innovation, a reçu l'autorisation de la part de l'Administration chinoise des produits alimentaires et...

16:26
LAVAL, Quebec and SOPHIA ANTIPOLIS, France, Nov. 2, 2017 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc.'s (NYSE: VRX and TSX: VRX) wholly owned subsidiary, Bausch + Lomb, a leading global eye health company, and Nicox S.A. (Euronext...

08:35
BURLINGTON, Mass., Nov. 2, 2017 /PRNewswire/ -- scPharmaceuticals, Inc., a pharmaceutical company focused on developing and commercializing products that have the potential to transform the way therapy is delivered, advance patient care and reduce...

08:33
DUBLIN, Nov. 2, 2017 /PRNewswire/ -- Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for the generic version of Picato® Gel (ingenol mebutate) 0.05%. The...


1 novembre 2017

09:44
WATERLOO, ON, Nov. 1, 2017 /CNW/ - Intellijoint Surgical®, a medical technology company, is pleased to announce that it has received FDA Clearance for revision Total Hip Arthroplasty (THA) with its intellijoint HIP® System. A 3D Mini-Optical...

08:45
LOGAN, Utah, Nov. 1, 2017 /PRNewswire/ -- IntraFuse, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for its...

08:30
PALM BEACH, Florida, November 1, 2017 /PRNewswire/ -- The U.S Food and Drug Administration is taking advantage of latest policy guidance spelled out in past years to speed drug approvals. Thirty-four new drug products and advanced medicines,...


31 octobre 2017

16:05
AUSTIN, Texas, Oct. 31, 2017 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today announced that it has received FDA clearance for the ARIES® Group A Strep Assay, a moderate complexity, sample to answer test for the direct detection of...

15:54
PHOENIX, Oct. 31, 2017 /PRNewswire/ -- Avella announced that it has been selected by AstraZeneca to distribute CALQUENCE® (acalabrutinib), a Bruton tyrosine kinase (BTK) inhibitor indicated for patients with mantle cell lymphoma (MCL) who have...

14:54
WILMINGTON, Del., Oct. 31, 2017 /PRNewswire/ -- AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to CALQUENCE®...

12:08
SILVER SPRING, Md., Oct. 31, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one...

11:03
SHANGHAI and LYON, France, Oct. 31, 2017 /PRNewswire/ -- Award-winning medical technology company EYE TECH CARE has received approval from the China Food and Drug Administration (CFDA) to begin marketing its EyeOP1® glaucoma treatment product in...

09:00
ABBOTT PARK, Ill., Oct. 31, 2017 /PRNewswire/ -- Abbott (NYSE: ABT) has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its Alinitytm ci-series instruments for clinical chemistry and immunoassay diagnostics. These innovative...

09:00
JERUSALEM, October 31, 2017 /PRNewswire/ -- BRH Medical, a medical device company developing and marketing innovative products for increasing blood flow and pain reduction, announced today that it has received 510 (k) clearance from the US Food and...

08:45
PALM BEACH, Florida, October 31, 2017 /PRNewswire/ -- The FDA has approved 34 drugs to date in 2017 after approving 22 novel drugs last year. Many biotech and pharma companies have dealt with the drug development process being lengthy and...


30 octobre 2017

09:15
PORT WASHINGTON, New York, October 30, 2017 /PRNewswire/ -- Equashield (http://www.equashield.com), a leading provider of Closed System Transfer Devices (CSTDs) for hazardous drugs, announced today that its Spanish distributor, Palex Medical, will...

08:00
TITUSVILLE, N.J., Oct. 30, 2017 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration (FDA) approved the 10 mg once-daily dose of XARELTO® (rivaroxaban) for reducing the continued risk for recurrent...

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