Le Lézard

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

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8 février 2018

08:00
DarioHealth Corp. , a leading global digital health company with mobile health and big data solutions, today announced it has entered into an agreement with a pharmaceutical company conducting a clinical study for a new drug related to managing...

07:00
Propeller Health, the leading digital solution for respiratory medicine, has been awarded International Organization for Standardization (ISO) 13485:2016 certification for medical device quality management systems. Propeller's FDA-cleared medical...

07:00
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 that the marketing...

01:22
Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) antagonist approved to treat moderate to severe plaque psoriasis.1 The updated label...


7 février 2018

10:15
Phosplatin Therapeutics LLC, a clinical stage pharmaceutical company focused on oncology drug development, announced today it has enrolled the first cohort of patients into its Phase I / II study of PT-112 as a single agent in relapsed or refractory...

10:00
RESTON, Va., Feb. 07, 2018 /PRNewswire-PRWeb/ -- MMJ International Holdings, the premier medical cannabis research company that is advancing the science of medical marijuana through FDA patient clinical research and the operation of medical cannabis...

08:30
Therapix Biosciences Ltd. ("Therapix" or the "Company"), a specialty clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments, announced today that it has held a pre-Investigational New Drug (pre-IND)...

05:00
Mesa Biotech Inc., a privately held, molecular diagnostic company that has developed an affordable PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced that it...


6 février 2018

09:45
Grifols (MCE: GRF, MCE: GRF.P, and NASDAQ: GRFS), a leading global producer of plasma-derived medicines and provider of a variety of postexposure prophylaxis and immune globulin products for patients, has received approval from the U.S. Food & Drug...

09:00
SANDY, Utah., Feb. 6, 2018 /PRNewswire-PRWeb/ --Utah Cord Bank (UCB) is pleased to announce that it has engaged in a consulting agreement with A3Cell and Dr. Barbara Krutchkoff* to help strategize its regulatory roadmap over the coming years. UCB...


5 février 2018

08:40
Today, True Health announced that it is now offering comprehensive testing for celiac disease and gluten sensitivity. When medically necessary, this testing will provide clinicians useful diagnostics to determine the specific cause of symptoms...

08:18
Trethera Corporation, a biopharmaceutical company committed to developing novel drugs targeting cellular nucleotide metabolism for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared its...

08:00
ChineseInvestors.com, Inc. ("CIIX" or the "Company"), the premier financial information website for the Chinese-speaking investors, today announced that its wholly-owned foreign enterprise CBD Biotechnology Co. Ltd. ("CBD Biotech") will launch 4 new...


1 février 2018

16:31
Allergan plc , a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Allergan's supplemental New Drug Application (sNDA) to expand the approved use of AVYCAZ® (ceftazidime and...

07:00
Imago BioSciences, a clinical-stage pharmaceutical company developing novel therapies for hematological and inflammatory diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted their Investigational New Drug (IND)...

06:11
Grünenthal announced today that Adhesys Medical Inc., a wholly-owned subsidiary of Grünenthal, has been granted Expedited Access Pathway (EAP) designation by the U.S. Food and Drug Administration (FDA) for VIVO. VIVO is a surgical sealant proposed...


31 janvier 2018

16:06
Ferring Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ZOMACTON® (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH) indicated for replacement of GH in adults with GH...


30 janvier 2018

09:00
Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced that it has received U.S. Food and Drug Administration (FDA) approval of its abbreviated new drug application (ANDA) for Bumetanide Tablets, USP, 0.5 mg, 1 mg, and 2 mg.  Bumetanide...

08:17
Perrigo Company plc today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Soolantra® (ivermectin) cream, 1%. Perrigo previously announced a patent litigation suit with Galderma...

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...

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