Le Lézard

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

9 janvier 2017

09:00
SAN FRANCISCO, Jan. 9, 2017 /PRNewswire/ -- ResMed (NYSE:RMD) announced today at the 35th annual J.P. Morgan Healthcare Conference that the U.S. Food and Drug Administration has cleared ResMed's AirMini, the world's smallest continuous positive...


6 janvier 2017

14:45
BOCA RATON, Fla., Jan. 6, 2017 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced that FDA has granted final approval of its ANDA bendamustine hydrochloride powder for IV (infusion), 25 mg/vial and 100 mg/vial, a generic version of Treanda®...

08:00
SOUTH PLAINFIELD, N.J., Jan. 6, 2017 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to RG7916 for the treatment of patients with Spinal...


5 janvier 2017

11:00
HAMPTON, Va., Jan. 5, 2017 /PRNewswire/ -- Medical device manufacturer ivWatch, LLC today announced United States availability of the ivWatch Model 400 for pediatric patients under the age of 18. The device is a continuous monitor for a patient's IV...

09:30
STATE COLLEGE, Pa., Jan. 5, 2017 /PRNewswire/ -- Keystone Nano, Inc., a biopharmaceutical company focused on improving cancer treatments through the application of nanotechnology, announced today that the U.S. Food and Drug Administration has...

08:30
RAANANA, Israel, Jan. 5, 2017 /PRNewswire/ -- XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTLB.TA) ("XTL" or the "Company"), a clinical-stage biopharmaceutical company developing treatments for autoimmune diseases, today announced the Company...

08:00
RICHMOND, Calif., Jan. 5, 2017 /PRNewswire/ -- Sangamo BioSciences, Inc. (NASDAQ: SGMO) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug application (IND) for its SB-525 gene therapy...

08:00
SAN DIEGO, Jan. 5, 2017 /PRNewswire/ -- Neurelis, Inc. today announced that it has finalized a Series B financing round led by HBM Healthcare Investments. In addition, LYZZ Capital, which led the Series A funding for Neurelis, has participated in the...


4 janvier 2017

17:09
RIDGEFIELD, Conn. and INDIANAPOLIS, Jan. 4, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved supplemental New Drug Applications for three type 2 diabetes medicines within the empagliflozin family to include data from the...

16:05
AUSTIN, Texas, Jan. 4, 2017 /PRNewswire/ -- Vermillion (NASDAQ: VRML) and ASPiRA LABS, a Vermillion company, today announced the receipt of an FDA Clarification Letter regarding OVA1 (MIA) and Overa (MIA2G).  This letter (see attached) is in...

10:07
SAN FRANCISCO, Jan. 4, 2017 /PRNewswire/ -- Biotech Showcase at the JP Morgan Healthcare Conference NeuroRx, a clinical stage biopharma company developing the first oral therapy for Acute Suicidal Ideation and Behavior (ASIB) in Bipolar Depression...

09:39
INDIANAPOLIS, Jan. 4, 2017 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its new dedicated, high-throughput HbA1c testing solution, the cobas c 513 analyzer, and HbA1c Gen. 3 assay has received 510(k) clearance from the U.S....

09:00
LOS ANGELES, Jan. 4, 2017 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing new therapeutics to treat patients with cancer, today announced that, in...

09:00
TAIPEI, Taiwan and SAN DIEGO, Jan. 4, 2017 /PRNewswire/ -- Senhwa Biosciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CX-4945 for the treatment of cholangiocarcinoma. CX-4945 is...

08:45
HAMPTON, Va., Jan. 4, 2017 /PRNewswire/ -- Registrar Corp's FSMA Compliance Wizard, a free tool that helps food facilities, importers, and farms determine their possible requirements under the Food Safety Modernization Act (FSMA), now incorporates...

07:35
DUBLIN and SAN FRANCISCO, Jan. 4, 2017 /PRNewswire/ -- Allergan plc, (NYSE: AGN) a leading global pharmaceutical company, and Medicines360, a nonprofit global women's health pharmaceutical company, today announced that the U.S. Food and Drug...


3 janvier 2017

08:20
MAHWAH, N.J., Jan. 3, 2017 /PRNewswire/ -- Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational New Drug (IND) application to initiate a...

08:00
BUENA, N.J., Jan. 3, 2017 /PRNewswire/ -- Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of three of the Company's abbreviated new drug applications (ANDAs) from...

08:00
MARLBOROUGH, Mass., Jan. 3, 2017 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted PMA approval for the Company's HIV-1 viral load monitoring assay. The Aptima® HIV-1 Quant assay...

07:35
DUBLIN, Jan. 3, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market NATRELLE INSPIRA® SoftTouch breast implants, offering women undergoing breast...


2 janvier 2017

03:00
NESS ZIONA, Israel, January 2, 2017 /PRNewswire/ -- Investor Shares BiondVax Vision of Commercializing World's First Universal Flu Vaccine BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) is honored to announce that Angels High Tech...


29 décembre 2016

16:23
HERTFORDSHIRE, England and PITTSBURGH, Dec. 29, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), today announced the U.S. launch of Methylphenidate Hydrochloride Extended-Release Tablets USP, 18 mg, 27 mg, 36 mg and 54 mg, a generic version of...

07:00
HERTFORDSHIRE, England and PITTSBURGH, Dec. 29, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), today announced the U.S. launch of Fosphenytoin Sodium Injection USP, 75 mg/mL, (50 mg PE*/mL), packaged in 100 mg PE*/2 mL, and 500 mg PE*/10 mL...


28 décembre 2016

16:33
HERTFORDSHIRE, England and PITTSBURGH, Dec. 28, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), today announced the U.S. launch of Ethynodiol Diacetate and Ethinyl Estradiol Tablets USP, 1 mg / 0.05 mg. Mylan's product was determined to be...

05:00
MENLO PARK, Calif., Dec. 28, 2016 /PRNewswire/ -- Escend Pharmaceuticals, Inc., a privately held company focused on the development of small molecule therapeutics for oncology orphan diseases, announced today that the FDA Office of Orphan Products...


27 décembre 2016

07:00
LEXINGTON, Massachusetts, December 27, 2016 /PRNewswire/ -- New FDA-approved indications for ADYNOVATE provides more hemophilia A patients access to proven prophylaxis with a simple, twice-weekly dosing schedule   Shire plc (LSE: SHP, NASDAQ:...


24 décembre 2016

15:01
COLD SPRING HARBOR, N.Y., Dec. 24, 2016 /PRNewswire/ -- Within a week of Christmas day, a drug called nusinersen will be in the hands of doctors across the nation, who will use it, most urgently, to treat young children with a severe and potentially...


23 décembre 2016

16:35
SILVER SPRING, Md., Dec. 23, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal...

00:31
BANGKOK, Dec. 23, 2016 /PRNewswire/ -- BioNet-Asia announced today that its first recombinant acellular Pertussis booster vaccine containing a proprietary genetically-detoxified Pertussis Toxin (PTgen), received Marketing Authorization Approval (MAA)...


22 décembre 2016

18:00
FORT WORTH, Texas, Dec. 22, 2016 /PRNewswire/ -- Alcon, the global leader in eye care and a division of Novartis, has received approval from the US Food and Drug Administration (FDA) for its AcrySof® IQ ReSTOR® +3.0D Multifocal Toric Intraocular Lens...


21 décembre 2016

23:27
PALO ALTO, Calif., Dec. 21, 2016 /PRNewswire/ -- Highlights AirXpanders has received U.S. Food and Drug Administration (FDA) de novo clearance for AeroForm®, opening the door for the device to be launched in the United States Commercial launch...

10:39
KFAR SABA, Israël, December 21, 2016 /PRNewswire/ -- Une étude pivot démarrera en 2017 en vue d'obtenir une autorisation de pré-commercialisation  CartiHeal (2009) Ltd., développeur d'un implant acellulaire prêt à l'emploi destiné à une utilisation...

05:30
Le nouveau système permet une mesure de la glycémie d'une exactitude exceptionnelle et l'administration précise d'insuline, y compris pour les personnes diabétiques les plus sensibles à l'insuline CHESTERBROOK, Pennsylvanie, le 21 décembre 2016...


20 décembre 2016

14:39
SILVER SPRING, Md., Dec. 20, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today expanded the approved use of Dexcom's G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose...

13:14
PINE BROOK, N.J., Dec. 20, 2016 /PRNewswire/ -- Elusys Therapeutics, Inc. (Elusys) today announced that the company published data and analyses used to determine the intravenous adult human dose for ANTHIM® (obiltoxaximab) Injection, its treatment...

11:16
KFAR SABA, Israel, December 20, 2016 /PRNewswire/ -- PMA Pivotal Study will start during 2017 CartiHeal (2009) Ltd., developer of a cell-free, off-the-shelf implant for use in cartilage and osteochondral defects, announced today the FDA approval of...

09:07
New system to enable exceptional glucose measuring accuracy and precise insulin delivery for even the most insulin-sensitive people with diabetes CHESTERBROOK, Pa., Dec. 20, 2016 /CNW/ -- Animas Corporation, part of the Johnson & Johnson Diabetes...

08:58
DUBLIN, Dec. 20, 2016 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO; TASE) today announced it has received approvals from the U.S. Food and Drug Administration for Abbreviated New Drug Applications referencing GlaxoSmithKline's Nicorette® White Ice...

08:00
TOKYO, Dec. 20, 2016 /PRNewswire/ -- Astellas Pharma Inc. (President and CEO: Yoshihiko Hatanaka, "Astellas") and Immunomic Therapeutics, Inc. (Founder & CEO: William Hearl, Ph.D., "Immunomic Therapeutics") today announced that the U.S. Food and Drug...


19 décembre 2016

14:00
PLAINSBORO, N.J., Dec. 19, 2016 /PRNewswire/ -- Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Tresiba® (insulin degludec injection 100 U/mL, 200...

12:48
WASHINGTON, Dec. 19, 2016 /PRNewswire-USNewswire/ -- Americans who don't want to see the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) prevail in the agencies' "war" against the coffee-like herb kratom are being...

11:21
SILVER SPRING, Md., Dec. 19, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. Rubraca is approved for women with...

10:17
BEDFORD, Mass., Dec. 19, 2016 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced the 510(k) clearance of their latest innovation, the GEM Premier 5000 in vitro diagnostic (IVD) analyzer with Intelligent Quality Management 2 (iQM®2) by...

07:00
SUNNYVALE, Calif., Dec. 19, 2016 /PRNewswire/ -- Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for Xpert® MRSA NxG, the next generation methicillin-resistant Staphylococcus aureus (MRSA)...

06:56
PHILADELPHIA, Dec. 19, 2016 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Supplemental New Drug Application (sNDA) for Morphine Sulfate Oral...

02:06
HACKENSACK, N.J. and PETACH TIKVAH, Israel, Dec. 19, 2016 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (Nasdaq: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today provided a corporate update and...


16 décembre 2016

09:48
SINGAPORE, Dec. 16, 2016 /PRNewswire/ -- QT Vascular Ltd., (the "Company" or "QT Vascular", and together with its subsidiaries, the "Group"), is a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for...

06:48
AACHEN, Germany and PISA, Italy, December 16, 2016 /PRNewswire/ -- Grünenthal receives Breakthrough Therapy Designation from U.S. FDA for neridronic acid for the treatment of complex regional pain syndrome (CRPS), a debilitating orphan disease...


15 décembre 2016

07:00
ST. PAUL, Minn., Dec. 15, 2016 /PRNewswire/ -- EnteroMedics Inc. (NASDAQ:ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced an...


14 décembre 2016

13:32
SILVER SPRING, Md., Dec. 14, 2016 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older.  Atopic...