Le Lézard

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

23 janvier 2017

07:00
WAYNE, Pa., Jan. 23, 2017 /PRNewswire/ -- Camber Spine Technologies, today announced that it has received 510(k) clearance for their Siconustm SI Joint Fixation System. Siconustm becomes the second product in the Camber Spine Technologies portfolio...

06:59
FRANKLIN LAKES, N.J., Jan. 23, 2017 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced its PleurXtm catheter system received U.S. Food and Drug Administration (FDA) 510(k)...


20 janvier 2017

11:15
UPPSALA, Sweden, Jan. 20, 2017 /PRNewswire/ -- OssDsign AB, a Swedish designer, manufacturer and distributor of next generation implants for cranial and facial reconstruction, today announced that it has received 510(k) clearance by the US FDA for...

09:00
KUOPIO, Finland, Jan. 20, 2017 /PRNewswire/ -- Bone Index Ltd., one of Europe's top new manufacturers of medical devices, has received 510(k) clearance from the Food and Drug Administration (FDA) for the second generation Bindex® point-of-care device...


19 janvier 2017

16:05
SILVER SPRING, Md., Jan. 19, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Trulance (plecanatide) for the treatment of Chronic Idiopathic Constipation (CIC) in adult patients. "No...

12:15
INDIANAPOLIS, Jan. 19, 2017 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it has received the 510(k) clearance for its Elecsys Troponin T Gen 5 STAT (TnT Gen 5 STAT) blood test for patients with a suspected heart attack. With this...

07:59
DUBLIN, Jan. 19, 2017 /PRNewswire/ -- Allergan plc, (NYSE: AGN), a leading global pharmaceutical company, announced today the approval of RHOFADEtm cream by the U.S. Food and Drug Administration (FDA) for the topical treatment of persistent facial...

07:05
HORSHAM, Pa., Jan. 19, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one...

07:00
LEXINGTON, Massachusetts, January 19, 2017 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465,...

07:00
NORTH CHICAGO, Ill., Jan. 19, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) approved IMBRUVICA® (ibrutinib) for the treatment of patients with...


18 janvier 2017

14:53
CLEVELAND, Jan. 18, 2017 /PRNewswire/ -- Ganeden continues its trend of being the first to receive regulatory approvals with the announcement that GanedenBC30® (Bacillus coagulans GBI-30, 6086) is FDA GRAS for infant formulas. Already known as the...

08:00
SAN DIEGO, Jan. 18, 2017 /PRNewswire/ -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe, rare diseases, today announced that its product...

05:00
SHANGHAI and GAITHERSBURG, Md., Jan 18, 2016 /PRNewswire/ -- Milestone represents first-time approval of biologics CTP for a joint multinational-local company venture in China WuXi AppTec, a global R&D enabling platform company, and MedImmune, the...

04:30
DALLAS, Jan. 18, 2017 /PRNewswire/ -- The OBALON 3-Balloon System is the first and only ingestible, non-surgical, fully reversible, 6 month, FDA-approved balloon system and Ultimate Bariatrics is proud to be one of the first practices in Texas to...


17 janvier 2017

09:45
LEXINGTON, Mass., Jan. 17, 2017 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases, today announced that its drug candidate for...

09:00
SCOTTSDALE, Ariz., Jan. 17, 2017 /PRNewswire/ -- CyMedica Orthopedics®, developer and manufacturer of innovative muscle rehabilitation systems announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for e-vivetm- the first...

07:15
PETACH-TIKVA, Israel, January 17, 2017 /PRNewswire/ -- OWC Pharmaceutical Research Corp. (OTCQB: OWCP), ("OWCP" or the "Company"), through its Israeli based fully owned subsidiary (One world Cannabis Ltd ) , a developer of cannabinoid-based...

07:00
ISFIYA, Israel, January 17, 2017 /PRNewswire/ -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK, CHEKW), a clinical stage medical diagnostics company developing a capsule-based system for preparation-free, colorectal cancer (CRC)...

07:00
TEL AVIV, Israel, January 17, 2017 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today the...


13 janvier 2017

20:15
WILMINGTON, Del., Jan. 13, 2017 /PRNewswire/ -- Dr. Isaias Irgau, from Christiana Institute of Advanced Surgery, is the first medical doctor to perform the newly FDA Approved Non-Surgical Weight Loss Solution ? AspireAssist in the Delaware Valley and...

16:51
INDIANAPOLIS, Jan. 13, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the new drug application (NDA) for...


12 janvier 2017

08:00
MONROE TOWNSHIP, N.J., Jan. 12, 2017 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world's leading companies in the diagnostic imaging business, announced today that its contrast agent LUMASON is...


11 janvier 2017

08:00
HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Jan. 11, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted...

07:17
MESA, Ariz., Jan. 11, 2017 /PRNewswire/ -- Paragon Vision Sciences, a world leader in orthokeratology, today announced China Food and Drug Administration (CFDA) approval and commercial availability of its corneal reshaping/ orthokeratology brand,...

03:00
CHARLOTTE, N.C., Jan. 11, 2017 /PRNewswire/ -- SonaCare Medical, leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, reports receipt of 510(k) regulatory clearance to market its latest version of Sonablate® in...


10 janvier 2017

11:05
PLEASANTON, Calif., Jan. 10, 2017 /PRNewswire/ -- Certent, Inc., a leading provider of software-as-a-service (SaaS) solutions for equity compensation and financial disclosure management, announces its partnership with NerdWallet, Inc....

09:00
SAN FRANSICSCO, Jan. 10, 2017 /PRNewswire/ -- ViraCyte, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Viralym-C, ViraCyte's T cell immunotherapy product designed to treat refractory...


9 janvier 2017

14:51
WAYNE, Penn., Jan. 9, 2017 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions,...

13:53
SAN FRANCISCO, Jan. 9, 2017 /PRNewswire/ -- Arterys, a pioneer in cloud-based medical imaging software, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Arterys Cardio DLTM application. Arterys Cardio DLTM...

12:51
SAN FRANCISCO, Jan. 9, 2017 /PRNewswire/ -- Arterys, a pioneer in cloud-based medical imaging software, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Arterys Cardio DLTM application. Arterys Cardio DLTM...

10:00
LAUSANNE, Switzerland, January 9, 2017 /PRNewswire/ -- Debiopharm International SA (Debiopharm - http://www.debiopharm.com), a Swiss-based company, part of Debiopharm Grouptm, today announced that triptorelin 6-month formulation (Decapeptyl® and...

10:00
GERMANTOWN, Maryland and HILDEN, Germany, January 9, 2017 /PRNewswire/ -- QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced the submission of QuantiFERON®-TB Gold Plus (QFT®-Plus), the fourth generation of the modern blood...

10:00
LAUSANNE, Suisse, January 9, 2017 /PRNewswire/ -- Cette formulation à libération prolongée est le premier traitement d'une durée d'action de 6 mois homologué dans l'UE pour la PPC   Debiopharm International SA (Debiopharm -...

09:02
ATLANTA, Jan. 9, 2017 /PRNewswire-USNewswire/ -- The Arthritis Foundation today announced they are hosting an Osteoarthritis (OA) Patient-Focused Drug Development (PFDD) meeting in the Washington, D.C. area on March 8, 2017. The meeting will provide...

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...

09:00
AUSTIN, Texas, Jan. 9, 2017 /PRNewswire/ -- Vermillion, Inc. (NASDAQ: VRML), a bio-analytical solutions company, today announced that the company and its wholly owned subsidiary, ASPiRA Labs, have received a Proprietary Laboratory...


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...