Le Lézard

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

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30 janvier 2018

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 the labeling of its contrast agent MultiHance® has obtained FDA approval for an...


29 janvier 2018

09:44
Meso Scale Diagnostics, LLC. (MSD) is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its conventional C-reactive protein (CRP) assay for in-vitro diagnostic (IVD) use in the United...

08:45
electroCore, LLC (electroCore), a commercial-stage bioelectronic medicine company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an expanded label for gammaCore® (nVNS) as an acute...

08:30
Theravance Biopharma, Inc. ("Theravance Biopharma") and Mylan N.V. ("Mylan") today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companies' recently submitted New Drug Application (NDA) for revefenacin...

08:00
CutisPharma announced today that the US Food and Drug Administration (FDA) has approved FIRVANQtm (vancomycin hydrochloride) for oral solution, for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus...

08:00
Bioness, Inc., the leading provider of cutting edge, clinically supported rehabilitation therapies, today announced it has received a medical device license from Health Canada for its StimRouter Neuromodulation System for the treatment of chronic...

07:00
MedyMatch Technology, a company focused on helping physicians provide accurate patient assessment through artificial intelligence (AI)-based insights, today announced that it has been granted Expedited Access Pathway (EAP) designation by the United...

02:18
The new regulatory clearance from the American Food and Drug Administration, FDA, concerns the SyMRI NEURO product package. Combined with FDA's clearance from August 2017, this means SyMRI as a whole can now be offered to clinics and hospitals on the...

02:13
The new regulatory clearance from the American Food and Drug Administration, FDA, concerns the SyMRI NEURO product package. Combined with FDA's clearance from August 2017, this means SyMRI as a whole can now be offered to clinics and hospitals on the...


26 janvier 2018

14:09
The Pancreatic Cancer Action Network (PanCAN) is excited to share that the Food & Drug Administration (FDA) just approved Lutathera®, a medication effective for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs),...

12:53
Perrigo Company plc today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Onexton® Gel (clindamycin phosphate 1.2% and benzoyl peroxide 3.75%). Perrigo previously settled litigation...

11:33
The U.S. Food and Drug Administration today approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This...


24 janvier 2018

07:51
Perrigo Company plc today announced it has received final approval from the U.S. Food and Drug Administration for the generic version of Estrace® Cream (estradiol vaginal cream, USP, 0.01%). This product will be marketed by Perrigo's partner, Impax...

07:46
Perrigo Company plc today announced it has received final approval from the U.S. Food and Drug Administration and has launched an AB rated generic version of Epiduo® (adapalene and benzoyl peroxide) Gel, 0.1%/2.5%....

06:00
BioAtla, LLC, a global biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, announced today the U.S. Food and Drug Administration (FDA) has cleared BioAtla's Investigational New Drug...


23 janvier 2018

12:09
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) has announced its role in the successful granting of a de novo by the U.S. Food and Drug Administration (FDA) on December 19, 2017, enabling IlluminOss Medical, Inc. to initiate...

09:00
TECHLAB, Inc., a leading developer and manufacturer of rapid non-invasive diagnostic tests for gastrointestinal diseases, today announced that it received U.S. Food and Drug Administration (FDA) clearance for the CAMPYLOBACTER QUIK CHEKtm and the...

09:00
TechCare Corp. , a technology company with a revolutionary delivery platform that uses vapor technology for natural health, wellness and beauty treatments, today announced it has signed its first distribution agreement with MWMedical B.V., a leading...

03:18
Swedish Orphan Biovitrum AB (publ) (Sobitm) announces that the FDA has issued a Study may proceed letter for the first study in humans, thereby accepting the investigational new drug (IND) application for the drug candidate SOBI003. In addition,...


22 janvier 2018

08:45
Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, announced today that its development partnership with a leading medical products company has resulted in the U.S. Food and Drug Administration...

08:00
Today, Elanco Animal Health, a division of Eli Lilly and Company , announced the approval of Credelio® (lotilaner). Credelio is a new monthly oral tick and flea treatment that is easy on dogs, but tough on ticks and fleas. This new tick and flea...


19 janvier 2018

12:06
Enzychem Lifesciences, Corp. (KONEX:183490), announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to EC-18 for the treatment of Acute Radiation Syndrome (ARS). The US FDA Orphan Drug Designation program...

08:25
Oramed Pharmaceuticals Inc. (www.oramed.com) Dear Shareholders, All the hard work and dedication in 2017 has successfully positioned Oramed to initiate a U.S. based multicenter 90-day treatment study under a FDA IND focused on the lowering of...

06:03
Grünenthal announced today that Adhesys Medical GmbH, a wholly-owned subsidiary of the Grünenthal Group, has received CE-Certification for MAR-CUTIS (Flix®). Flix® is a topical skin adhesive for surgical use and the first product from Grünenthal's...


18 janvier 2018

17:00
Medizone International, Inc. or Medizone, manufacturer of the AsepticSure® system, today announced that as a result of its meeting with representatives of the U.S. Food and Drug Administration ("FDA") on January 18, 2018, it has reached decisions...

16:05
QIAGEN N.V. today announced that the U.S. Food and Drug Administration (FDA) has approved a PMA supplement extending the indications for use of QIAGEN's therascreen® EGFR RGQ PCR Kit as a companion diagnostic to guide the use of Boehringer...

08:30
Aquestive Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application for clobazam Oral Soluble Film (clobazam OSF) for adjunctive treatment of seizures associated...

03:00
Biohaven Pharmaceutical Holding Company Ltd. (Biohaven or the "Company") and its wholly owned subsidiary, Biohaven Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it may proceed...


17 janvier 2018

16:15
Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for...

09:00
Lyric Pharmaceuticals, Inc (Lyric), a biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of ulimorelin (LP101) for the treatment of enteral...

08:00
International Biophysics Corporation, a global medical device manufacturer based in Austin, Texas, announced they have received FDA 510k clearance for their FloPump 32 centrifugal disposable heart pump. The FloPump 32 is one of the smallest...

06:00
Outpost Medicine, a biopharmaceutical company focused on the development of new treatments of urologic and gastrointestinal disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted two Investigational New Drug (IND)...


16 janvier 2018

08:30
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced findings from the U.S. Food and Drug Administration's (FDA) Mini-Sentinel assessment, confirming the positive safety and efficacy profile of XARELTO® (rivaroxaban) established...

08:00
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) for the first-line treatment of patients with metastatic non-small cell lung cancer...

01:20
Sandoz, a Novartis division and the global leader in biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed...


15 janvier 2018

02:04
PLENVU® est la première préparation intestinale d'un litre à base de PEG Il a été prouvé que PLENVU® était supérieur à MOVIPREP® pour provoquer un nettoyage de haute qualité du côlon ascendant - une région importante pour la détection des adénomes...

02:00
PLENVU® is the first 1-litre PEG bowel preparation PLENVU® is superior to MOVIPREP® in providing high-quality cleansing in the colon ascendens - an important area for adenoma detection Norgine B.V. today announced marketing authorisation for...


12 janvier 2018

09:39
The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited...

08:00
GSK [LSE/NYSE: GSK] announced today it has received approval from the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research expanding the indication for FLUARIX® QUADRIVALENT (Influenza Vaccine) to include use in...

07:00
Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. ("Valeant") , today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application for IDP-121 (tretinoin 0.05%) lotion (ALTRENOtm1)...


11 janvier 2018

07:00
Norgine B.V. today announced the launch of LYMPHOSEEK® (Tc 99m tilmanocept) in Finland and Sweden. LYMPHOSEEK® is a radiopharmaceutical used for diagnostic purposes by nuclear medicine specialists and surgeons. It is specifically designed for a...

07:00
Norgine B.V. a annoncé aujourd'hui le lancement de LYMPHOSEEK® (Tm 99m tilmanocept) en Finlande et en Suède. LYMPHOSEEK® est un produit radiopharmaceutique utilisé à des fins diagnostiques par les chirurgiens et les spécialistes de la médecine...

06:30
Boston Scientific Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved the Spectra WaveWritertm Spinal Cord Stimulator (SCS) System. It is the first and only system approved by the FDA to simultaneously provide...


10 janvier 2018

08:00
AstraZeneca today announced that BYDUREON® BCisetm (exenatide extended-release) injectable suspension 2mg is now available in pharmacies across the United States. BYDUREON BCise was recently approved by the U.S. Food and Drug Administration for...

04:08
La FDA a accordé une approbation d'exemption pour dispositif expérimental (IDE - Investigational Device Exemption approval) pour mener une étude clinique examinant l'utilisation du système de ballon ProSpacetm dans le but d'éviter la toxicité rectale...

04:07
FDA has granted investigational Device Exemption approval (IDE) to conduct a pivotal clinical study examining the use of the ProSpace[TM] Balloon System to prevent rectal toxicity following prostate cancer radiotherapy BioProtect, the...


8 janvier 2018

09:00
Clearbridge BioMedics today announced that it has successfully registered its target cell enrichment device, the ClearCell® FX1 system, with the U.S. Food and Drug Administration (FDA) as a Class I Medical Device, for in vitro diagnostic use. This...

08:10
Varian today announced its Halcyontm system has received Taiwan FDA approval, which allows the company to market this new cancer treatment system in Taiwan.  This approval further expands the global availability of Halcyon and high-quality,...

08:00
AbbVie , a global research and development-based biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational, once-daily oral JAK1-selective inhibitor...

08:00
STS Medical Ltd. ("S.T.Stent"), a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T; OTCQX: TRNLY), announced today that it received regulatory clearance from the United States Food and Drug Administration (FDA) for its...

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