Le Lézard

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

10 mai 2017

12:44
NxStage Medical, Inc. , a leading medical technology company focused on advancing renal care, today announced that its next generation hemodialysis system has received FDA clearance.  This innovative system consists of new features and capabilities,...

08:00
Bridge Therapeutics, Inc., an innovative development-stage specialty pharmaceutical company, has announced that its CEO and Chief Scientific Officer Greg Sullivan, MD, will present at BioTrinity 2017 in London on Thursday, May 11....

05:46
Taiwan-based vaccine provider Adimmune (4142.TT) successfully obtained approval of its quadrivalent flu vaccine (ADIMFLU-S(QIS)) from Taiwan FDA. Adimmune will start the commercial production of quadrivalent flu vaccine in 2017 and supply the...

03:00
Bridge Therapeutics, Inc., an innovative development-stage specialty pharmaceutical company, has announced that its CEO and Chief Scientific Officer Greg Sullivan, MD, will present at BioTrinity 2017 in London on Thursday, May 11. BioTrinity is...


9 mai 2017

15:53
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the US and Canada, and Pfizer Inc. today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) Injection for the treatment of...

09:00
INSIGHTEC, the leader in MR-guided Focused Ultrasound (MRgFUS), announced today that the FDA has approved its Exablate Neuro (Model 4000) system for use with 1.5T MRI in the non-invasive treatment of essential tremor (ET) in patients who have not...

07:00
Biscayne Neurotherapeutics, Inc., a clinical-stage company developing novel treatments for neurological disorders, today announced that lead compound BIS-001 has received an Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for...

06:30
Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for the Resonatetm family of implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems. The approval includes new...


8 mai 2017

18:47
Valeant Pharmaceuticals International, Inc.'s wholly owned subsidiary, Bausch + Lomb, a leading global eye health company, today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for brimonidine...

16:15
Novartis announced today that the US Food and Drug Administration (FDA) has approved the Kisqali® Femara® Co-Pack (ribociclib tablets; letrozole tablets) for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2...

13:55
BIOTRONIK today announced FDA approval of the company's MultiPole Pacing (MPP) technology, providing physicians with additional treatment options for heart failure patients who have been non-responsive to cardiac resynchronization therapy (CRT).1 MPP...

13:23
BIOTRONIK today announced FDA approval and the launch of Sentus ProMRI®, the thinnest quadripolar left ventricular lead available in the United States. This introduction completes BIOTRONIK's second-generation ProMRI lead portfolio, which also...

12:03
CurveBeam announced it has received FDA 510(k) clearance for the InReach, a Cone Beam CT imaging system primarily designed for the hand, wrist & elbow; & lower extremities in non-weight bearing position. The InReach is...

08:00
Atlanta-based company MagVenture Inc. can now add another FDA cleared medical device to its product portfolio. The technology behind is Transcranial Magnetic Stimulation, also known as TMS. It is indicated for the treatment of major depressive...

07:00
Oncolytics Biotech® Inc. (Oncolytics or the Company) announced today that the United States Food and Drug Administration (FDA) has granted Fast Track designation for REOLYSIN®, the Company's proprietary immuno-oncology viral agent, for the...


5 mai 2017

18:55
MT Pharma America, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted approval of RADICAVAtm (edaravone), as an intravenous infusion treatment for amyotrophic lateral sclerosis (ALS), a rapidly progressive neurodegenerative...

17:03
The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's disease. "After learning about the use of...


4 mai 2017

12:10
Spherix Global Insights recently released data collected from 257 rheumatologists in France, Germany, Italy, Spain and the UK, revealing a high unmet need for small molecules and alternate mechanism biologics for the treatment of rheumatoid arthritis...

09:00
Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today that it has released the new plasma hysteroscopic resection and vaporization full...


3 mai 2017

08:00
Luminex Corporation today announced that it has received FDA clearance for the ARIES® Bordetella Assay for direct detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acid in...

06:00
Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has received US Food and Drug...


2 mai 2017

15:52
Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced approval of the VENTANA PD-L1 (SP263) Assay by the US Food and Drug Administration (FDA) as a complementary diagnostic3 to provide PD-L1 status for patients with locally advanced or metastatic...

07:00
BioDelivery Sciences International, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) revising the indication to...


1 mai 2017

15:52
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to IMFINZItm (durvalumab). IMFINZI is indicated for the treatment of...

10:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its new, dedicated high-volume testing immunoassay solution for the cobas 8000 modular analyzer series, the cobas e 801 module, has received 510(k) clearance from the U.S. Food and Drug...

09:00
Conavi Medical Inc. (www.conavi.com) is pleased to announce 510(k) clearance from the FDA for its Foresight ICE System expanded feature set. The enhancements include color doppler, pulsed wave doppler, 2D and 3D measurements, and ECG-gated 3D...

08:30
Many U.S. importers are required to comply with the U.S. Food and Drug Administration (FDA) Foreign Supplier Verification Program (FSVP) rule by May 30, 2017.   Finalized in November 2015 under the Food Safety Modernization Act (FSMA), FDA's FSVP...

08:00
Sanofi Genzyme, une division de Sanofi-Aventis Canada Inc., a annoncé aujourd'hui que Santé Canada a récemment approuvé CerdelgaMC (capsules d'éliglustat), le seul traitement oral de première intention indiqué pour le traitement des patients adultes...


28 avril 2017

11:43
Novartis announced today the US Food and Drug Administration (FDA) has approved Rydapt® (midostaurin, formerly PKC412) for two indications. The first indication is for the treatment of acute myeloid leukemia (AML) in newly diagnosed patients who are...

10:07
The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy. The...


27 avril 2017

19:42
WARNING: HEPATOTOXICITY Severe and sometimes fatal hepatotoxicity has occurred in clinical trials. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested by...

15:31
Allergan recently announced that it has received FDA approval for TrueTeartm Intranasal Tear Neurostimulator, the first and only FDA-cleared device developed to temporarily increase tear production in adult patients. "The FDA approval of the...

13:27
The U.S. Food and Drug Administration today approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. Brineura is the first FDA-approved treatment to slow loss of walking ability (ambulation) in symptomatic pediatric...

13:11
The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug sorafenib. This is the...

12:35
La Federal Drug Agency (FDA) des États-Unis accorde à l'entreprise Agrisoma Biosciences Inc., établie au Québec, l'autorisation réglementaire de fabriquer un nouveau produit d'alimentation animale sans OGM et à faible teneur en carbone. Cette...

11:30
The US Federal Drug Agency (FDA) is giving Quebec-based Agrisoma Biosciences Inc. regulatory clearance to produce a new GMO-free and low carbon animal feed. The approval gives Agrisoma agricultural license to...

11:06
Novo Nordisk today announced that the US Food and Drug Administration (FDA) approved an updated product label for Saxenda® (liraglutide) injection 3 mg, including data showing that approximately half of patients on Saxenda® (26% vs 10% on placebo)...


26 avril 2017

16:30
Mentor Worldwide LLC, a global leader in breast aesthetics, today announced that it has received approval from the U.S. Food & Drug Administration (FDA) to market MemoryGel® Xtra silicone gel-filled breast implants in the U.S. The new addition to the...

16:01
Impax Laboratories, Inc. , a specialty pharmaceutical company, today announced it has received final U.S. Food and Drug Administration (FDA) approval for a generic version of Vytorin® (ezetimibe/simvastatin tablets), 10/10, 10/20, 10/40 and 10/80 mg,...

10:13
Source-Ray Inc., the largest American manufacturer of portable X-Ray systems announced today the FDA 510(k) approval for its new X-Ray unit - the model UC-5000 ? A fully DIRECT-DIGITAL TURNKEY system for the Urgent Care market. "Source-Ray Inc. was...

08:41
Silvergate Pharmaceuticals, Inc. (www.silvergatepharma.com), leaders in the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration (FDA) approved XATMEP...

08:00
Inspirion Delivery Sciences, LLC ("Inspirion") announced that the United States Food and Drug Administration (FDA) has approved RoxyBondtm (oxycodone hydrochloride) tablets, for oral use, CII, indicated for the management of pain severe enough to...

07:30
Valeant Pharmaceuticals International, Inc.'s wholly owned subsidiary, Bausch + Lomb, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Vitessetm, the first and only hypersonic  device for vitreous...

01:00
Natpar is the first and only licensed recombinant human parathyroid hormone therapy for chronic hypoparathyroidism  Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the European Commission (EC) has granted Conditional Marketing Authorisation...


25 avril 2017

08:00
Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved the companies' new supplemental Biologics License Application (sBLA) for a once-monthly (every four weeks), 300 mg dose of Praluent®...

08:00
Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration (FDA) approved the companies' new supplemental Biologics License Application (sBLA) for a once-monthly (every four weeks), 300 mg dose of Praluent®...


24 avril 2017

08:30
Sanofi today announced that the U.S. Food and Drug Administration (FDA) approved Thymoglobulin® [anti-thymocyte globulin (rabbit)], for use in conjunction with concomitant immunosuppression in the prophylaxis, or prevention, of acute rejection in...

06:00
Millennium Medical Technologies (MMT) (www.mmt-us.com) has become the first in the nation to receive FDA clearance for a reusable fat collection and transfer system used in plastic or reconstructive surgery and regenerative aesthetics.  This FDA...


20 avril 2017

08:00
American Society of Interventional Pain Physicians Annual Meeting, Booth #407 -- Halyard Health , a medical technology company focused on eliminating pain, speeding recovery and preventing infection, today announced the U.S. Food and Drug...


19 avril 2017

09:00
The circular anastomosis is one of the most critical steps in cancer surgery and has a high risk for complications. Complications can include leaks and bleeding which can require reoperation. In an effort to make measurable clinical and cost-of-care...