Le Lézard

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

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7 août 2017

09:37
CMP Pharma today announced that the US Food and Drug Administration (FDA) has granted final approval of the company's New Drug Application (NDA) for CaroSpir® (Spironolactone Oral Suspension, 25 mg/5mL), the first and only FDA-approved oral liquid...

08:00
Mylan N.V. , a leading global pharmaceutical company, today announced receipt of tentative approval from the U.S. Food and Drug Administration under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for...

08:00
Allergan plc , a leading global pharmaceutical company, and Medicines360, a global nonprofit women's health pharmaceutical company with a mission of expanding access to quality medicines, announced that the U.S. Food and Drug Administration (FDA)...

07:00
Polaryx Therapeutics, Inc, a biotech company developing oral small molecule therapeutics for Late Infantile Neuronal Ceroid Lipofuscinosis (LINCL) and for other forms of NCL, commonly known as Batten disease, has been granted Orphan Drug Designation...

04:00
L'extrait de curcuma BCM-95® reçoit une «  No Questions Letter » (lettre de non-objection) de la part de la FDA   La curcumine BCM-95® d'Arjuna Naturals Extracts Ltd., un extrait de curcuma hautement puissant, a reçu une lettre de non-objection de...


4 août 2017

09:35
The Society of Chemical Manufacturers and Affiliates (SOCMA) Bulk Pharmaceuticals Task Force today commends the U.S. Senate on passage of the Food and Drug Administration Reauthorization Act of 2017, which includes the Generic Drug User Fees (GDUFA)...

09:20
Perrigo Company plc today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Mirvaso® (brimonidine) topical gel 0.33%. Perrigo previously settled litigation with Galderma Laboratories,...


3 août 2017

15:32
The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate...

15:28
AbbVie , a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved MAVYRETtm (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV)...

14:49
The Leukemia & Lymphoma Society (LLS) applauds the U.S. Food and Drug Administration (FDA) approval today of CPX-351 (VyxeosTM), an innovative combination of two chemotherapy drugs being used to treat two high-risk subgroups of acute myeloid leukemia...

14:04
Nexus Pharmaceuticals announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Isoproterenol Hydrochloride Injection. Nexus Pharmaceuticals' Isoproterenol...

10:15
Jazz Pharmaceuticals plc today announced that the company will host a webcast on Monday, August 7, 2017 at 4:30 p.m. EDT/9:30 p.m. IST to provide investors with an update on Vyxeostm (daunorubicin and cytarabine) liposome for injection, which was...

10:10
Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) has approved Vyxeostm (daunorubicin and cytarabine) liposome for injection for the treatment of adults...

09:53
The U.S. Food and Drug Administration today approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is a...

07:00
Intec Pharma Ltd. , a clinical stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pilltm platform technology, announces the results from a Phase I clinical trial of AP-CBD/THC, its Accordion Pill platform...

05:00
BCM-95® Turmeric Extract Granted a 'No Questions' Letter from the FDA  Arjuna Naturals Extracts Ltd.'s BCM-95®, a high-potency turmeric extract, has been granted a 'No Questions' response letter from the US Food and Drug Administration (FDA)....


2 août 2017

21:23
WuXi Biologics (2269.HK), a global leading open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, and its partner TaiMed Biologics (4147.TWO) today announced that the...

16:49
Janssen Biotech, Inc. announced today that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) did not recommend approval of sirukumab (proposed trade name PLIVENSIAtm) for the treatment of moderately to severely active...

13:32
The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of adult patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.1 IMBRUVICA is the first and...

13:07
AbbVie , a global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of adult patients with chronic graft-versus-host-disease (cGVHD) after failure of one or...

11:48
The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved...


1 août 2017

15:49
Today marks another significant advance in the offensive against acute myeloid leukemia (AML), one of the most deadly blood cancers that takes more than 10,000 lives in the U.S. each year. The Leukemia & Lymphoma Society (LLS) applauds The U.S. Food...

13:00
Xavant Technology (Pty) Ltd today announced that the U.S. Food and Drug Administration (FDA) cleared their Stimpod NMS460. With the U.S. patent awarded on proprietary hybrid pulsed radio frequency (PRF) waveform, this non-invasive neuromodulation...

11:31
The U.S. Food and Drug Administration today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion...

09:08
Sirnaomics, Inc. (www.sirnaomics.com), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announced today that the Office of Orphan Product Development division of the USA FDA has granted Orphan Drug Designation to...

08:00
The Food and Drug Administration authorized the use of a qualified health claim confirming soybean oil's ability to reduce the risk of coronary heart disease.1 Soybean oil is the most widely used edible oil in the United States.2 Most oils sold as...


31 juillet 2017

15:20
Kitov Pharmaceuticals Holdings Ltd. , an innovative biopharmaceutical company, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for KIT-302, its lead drug candidate. KIT-302 is a...

12:07
Bunge North America, the North American arm of Bunge Limited , is pleased to announce that the U.S. Food and Drug Administration (FDA) approved its petition for a qualified health claim linking consumption of soybean oil to reduced risk of coronary...

09:00
Amgen and Allergan plc. today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 980, a biosimilar candidate to Herceptin® (trastuzumab). Amgen and Allergan are collaborating on...

07:30
Accuray Incorporated announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its iDMStm Data Management System, enabling its use with the Company's TomoTherapy® platform. It's designed to integrate with...

07:00
Bruker today announces that it has received US Food & Drug Administration (FDA) clearance for its third, further expanded claim for the market-leading MALDI Biotyper-CA (MBT-CA) system for fast, accurate and cost-effective microbial identification....

07:00
Immunalysis Corporation, a division of Alere Inc. , today announced that its SEFRIAtm Fentanyl Urine Enzyme Immunoassay has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for the qualitative detection of fentanyl in...


28 juillet 2017

09:00
Under the Orphan Drug Act (ODA), drugs, vaccines, and diagnostic agents qualify for orphan status if they are intended to treat a disease affecting less than 200,000 American citizens. Orphan drug sponsors qualify for seven-year FDA-administered...

08:00
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced the U.S. Food and Drug Administration (FDA) approved VARIBAR NECTAR (barium sulfate) oral suspension...


27 juillet 2017

17:49
Amgen  today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Amgen's supplemental Biologics License Application (sBLA) for Repatha® (evolocumab), a PCSK9 inhibitor. If approved by the FDA, the U.S....

11:28
Quantitative Insights, Inc. (QI) today announced that it has received regulatory clearance (via De Novo classification) from the U.S. Food and Drug Administration (FDA) for its QuantXtm Advanced system, the industry's first computer-aided diagnosis...

10:00
The XERO Viewer is part of Agfa HealthCare's award-winning Enterprise Imaging platform, which consolidates imaging data from multiple service lines and provides secure access to a patient's medical images, in one view, accessible 'anywhere, anytime'....

09:10
Acella Pharmaceuticals, LLC, a leading U.S. developer of specialty pharmaceuticals across several therapeutic categories, recently announced the Food and Drug Administration's approval of the Company's abbreviated new drug application (ANDA) for a...

08:00
Trovagene, Inc. , a precision medicine biotechnology company, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) Application for PCM-075, a Polo-like Kinase 1 (PLK1) inhibitor, and has...

08:00
Eiger BioPharmaceuticals, Inc. , focused on the development and commercialization of targeted therapies for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for pegylated interferon...

03:00
AMO Pharma Limited ("AMO Pharma"), a privately held biopharmaceutical company focusing on debilitating diseases with limited or no treatment options, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation...


26 juillet 2017

18:40
Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for FYCOMPA® (perampanel) CIII as monotherapy use for the treatment of partial-onset seizures (POS) with...

08:05
Sequoia Sciences a annoncé avoir obtenu la désignation Fast Track de la part de la Food and Drug Administration (FDA) américaine, pour son vaccin expérimental novateur destiné au traitement des infections des voies urinaires (IVU) récurrentes causées...

07:00
Algatech (Algatechnologies) Ltd. Received Brazilian Health Regulatory Agency (Anvisa) approval for its all-natural astaxanthin AstaPure® to be used as a food ingredient. Approval was granted thanks to the high quality and purity of this powerful...


25 juillet 2017

11:56
Hologenix, LLC, fabricant de Celliant, la technologie textile sensible la plus avancée au monde et testée...

10:49
ChiRhoClin, Inc. is pleased to notify the medical community that ChiRhoStim® (Human Secretin for Injection) has received FDA approval, updating its package insert. There are two significant changes to the package insert.  The first change eliminates...

10:26
Vertera Spine, a developer of medical devices using advanced biomaterial technologies, today announced the COALESCEtm Lumbar Interbody Fusion Device has received U.S. Food and Drug Administration (FDA) 510(k) clearance for use in anterior,...

10:09
Hologenix, LLC, fabricant de Celliant, la technologie textile sensible la plus avancée au monde et...

09:00
Resverlogix Corp. ("Resverlogix" or the "Company") is pleased to announce the receipt of a positive Type C written response from the Division of Metabolism and Endocrinology Products of the U.S. Food and Drug Administration (FDA). In light of...

08:00
Global biotherapeutics leader CSL Behring announced today that HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) is now available in the United States. The U.S. Food and Drug Administration (FDA) approved HAEGARDA on June 22, 2017 for routine...

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