Le Lézard

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

19 janvier 2017

12:15
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 clearance, Roche is the first IVD company...

07:59
Allergan plc, , 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 erythema (redness) associated with rosacea in...

07:05
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 prior anti-CD20-based therapy.1 Accelerated...

07:00
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, a long-acting, triple-bead, mixed amphetamine salts...

07:00
AbbVie , a global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) approved IMBRUVICA® (ibrutinib) for the treatment of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who require systemic...


18 janvier 2017

14:53
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 leading probiotic ingredient for functional...

08:00
aTyr Pharma, Inc. , a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe, rare diseases, today announced that its product candidate Resolaristm was granted Fast Track designation by...

05:00
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 global biologics research and development arm of AstraZeneca,...

04:30
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 offer this new tool in helping people...


17 janvier 2017

09:45
Pulmatrix, Inc. , a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases, today announced that its drug candidate for treating fungal infections in the lungs of CF patients, PUR1900,...

09:00
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 of its kind app-controlled, data-driven muscle...

07:15
OWC Pharmaceutical Research Corp. , ("OWCP" or the "Company"), through its Israeli based fully owned subsidiary (One world Cannabis Ltd ) , a developer of cannabinoid-based therapies targeting a variety of different medical conditions and disorders,...

07:00
Check-Cap Ltd. (the "Company" or "Check-Cap") , a clinical stage medical diagnostics company developing a capsule-based system for preparation-free, colorectal cancer (CRC) screening, today announced the enrollment of the first patient in its...

07:00
BioLineRx Ltd. , a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today the initiation of a second Phase 2a trial investigating BL-8040 in combination with...


13 janvier 2017

20:15
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 the Greater Philadelphia area. The FDA has...

16:51
Eli Lilly and Company and Incyte Corporation announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the new drug application (NDA) for investigational baricitinib, a once-daily oral medication for the...


12 janvier 2017

08:00
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 the first ultrasound contrast agent to obtain Food and...


11 janvier 2017

08:00
Mylan N.V. and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's biologics license application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through...

07:17
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, Paragon CRT® Contact Lenses in China.   The...

03:00
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 the United States. Sonablate was the first...


10 janvier 2017

11:05
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. NerdWallet's mission is to bring...

09:00
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 cytomegalovirus (CMV) infections in patients...


9 janvier 2017

14:51
Egalet Corporation ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions, today announced that the U.S. Food and Drug...

13:53
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 is the first technology to be cleared by the...

12:51
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 is the first technology to be cleared by the...

10:00
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 Pamorelin® 22.5 mg) received approval for the treatment of...

10:00
QIAGEN N.V. today announced the submission of QuantiFERON®-TB Gold Plus (QFT®-Plus), the fourth generation of the modern blood test for detecting tuberculosis (TB) infection, for pre-market approval (PMA) by the U.S. Food and Drug Administration...

10:00
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 - http://www.debiopharm.com), une société de Debiopharm Grouptm, basée en...

09:02
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 the U.S. Food and Drug Administration (FDA) and...

09:00
ResMed 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 airway pressure (CPAP) device. ResMed's tiny yet...

09:00
Vermillion, Inc. , a bio-analytical solutions company, today announced that the company and its wholly owned subsidiary, ASPiRA Labs, have received a Proprietary Laboratory Analyses (PLA) code (0003U) for Overa (MIA2G), Vermillion's second-generation...


6 janvier 2017

14:45
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® by Cephalon, Inc. Breckenridge, and its...

08:00
PTC Therapeutics, Inc. 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 Muscular Atrophy (SMA). RG7916 is part of PTC's joint development...


5 janvier 2017

11:00
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 and provides early detection of an...

09:30
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 approved the company's Investigational New Drug (IND)...

08:30
XTL Biopharmaceuticals Ltd.  ("XTL" or the "Company"), a clinical-stage biopharmaceutical company developing treatments for autoimmune diseases, today announced the Company intends to pursue Sjögren's syndrome as the second indication for its lead...

08:00
Sangamo BioSciences, Inc. 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 program for the treatment of  hemophilia A. The IND is now...

08:00
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 Series B round.  The company will...


4 janvier 2017

17:09
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 landmark EMPA-REG OUTCOME® trial. The data show that empagliflozin...

16:05
Vermillion 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 reference to the September 7, 2016 FDA Safety Communication...

10:07
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 has received FDA clearance to proceed with...

09:39
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. Food and Drug Administration (FDA)....

09:00
CytRx Corporation , a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing new therapeutics to treat patients with cancer, today announced that, in response to a request from the company, the U.S. Food and...

09:00
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 a novel small molecule drug that inhibits protein kinase...

08:45
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 FDA's Intentional Adulteration Rule. ...

07:35
Allergan plc, a leading global pharmaceutical company, and Medicines360, a nonprofit global women's health pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's supplemental...


3 janvier 2017

08:20
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 phase I study of its lead candidate, GBR...

08:00
Teligent, Inc. , 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 the U.S. Food and Drug Administration (FDA) of Nystatin...

08:00
Hologic, Inc. 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 is a nucleic acid amplification test for the quantitative...

07:35
Allergan plc 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 reconstruction, augmentation or revision surgery a...