Le Lézard

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

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5 septembre 2017

14:00
HOUSTON, Sept. 5, 2017 /PRNewswire/ -- C4 Imaging LLC is pleased to announce an additional US Food and Drug Administration 510(k) clearance for its Siriustm MRI Marker, a novel positive-signal MRI Marker that is used during the treatment of prostate...

13:47
PRINCETON, N.J., Sept. 5, 2017 /PRNewswire/ -- Guerbet LLC USA, the US affiliate of the global specialist in contrast products and solutions for medical imaging, announced today that the US Food and Drug Administration (FDA) has approved Dotarem®...

09:35
KEYSTONE, Colo., Sept. 5, 2017 /PRNewswire/ -- Sapheneia and Scannerside received FDA 510(k) clearance to market their XR-29 DoseCheck solution. Scannerside DoseCheck is a third-party Vendor neutral CT product that makes it affordable to update...

09:12
CHICAGO, Sept. 5, 2017 /PRNewswire/ -- 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...

09:00
WASHINGTON, Sept. 5, 2017 /PRNewswire/ -- The Regulatory Affairs Professionals Society (RAPS) has just published the updated 10th tenth edition of its popular text, Fundamentals of US Regulatory Affairs, the most extensive reference available on...

08:00
PALO ALTO, Calif., Sept. 5, 2017 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare diseases, today announced that the U.S. Food and Drug Administration (FDA)...

07:08
STOCKHOLM, Sept. 05, 2017 /PRNewswire/ -- Swedish Orphan Biovitrum AB (publ) (Sobitm) has received approval from the U.S. Food and Drug Administration (FDA) for a reduced dosing frequency for Orfadin® (nitisinone) from twice daily to once daily in...

07:02
TEL AVIV, Israel, Sept. 5, 2017 /PRNewswire/ -- Cellect Biotechnology Ltd. (NASDAQ: APOP), a developer of stem cells selection technology, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for...

06:53
PHILADELPHIA, Sept. 5, 2017 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Esomeprazole Magnesium...

06:00
JERUSALEM, Sept. 5, 2017 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it has...


1 septembre 2017

14:33
RYE BROOK, N.Y., Sept. 1, 2017 /PRNewswire-USNewswire/ -- The steady march of progress in new treatments for patients with acute myeloid leukemia (AML), one of the most deadly blood cancers which takes more than 10,000 lives in the U.S. each year,...

14:00
BRIDGEWATER, N.J., Sept. 1, 2017 /PRNewswire-USNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) granted tentative approval for Admelog® (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin analog....

12:20
WASHINGTON, BUENOS AIRES, Argentine, MADRID et GENÈVE, September 1, 2017 /PRNewswire/ -- Le 29 août, la Food and Drug Administration (FDA) des États-Unis a approuvé la demande de nouveau médicament de Chemo Research pour le benznidazole. Il s'agit...

11:11
SILVER SPRING, Md., Sept. 1, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33...

08:30
BAUDETTE, Minn., Sept. 1, 2017 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has received approval from the U.S. Food and Drug Administration ("FDA") of its Abbreviated New Drug Application ("ANDA") for...


31 août 2017

10:39
WASHINGTON, BUENOS AIRES, Argentina, MADRID and GENEVA, August 31, 2017 /PRNewswire/ -- On August 29th, the U.S. Food and Drug Administration (FDA) approved Chemo Research's New Drug Application (NDA) for benznidazole. This is the first drug ever...

09:45
WASHINGTON D.C., BUENOS AIRES, Argentina, MADRID and GENEVA, August 31, 2017 /PRNewswire/ -- On August 29th, the U.S. Food and Drug Administration (FDA) approved Chemo Research's New Drug Application (NDA) for benznidazole. This is the first drug...

08:14
BOSTON, Aug. 31, 2017 /PRNewswire/ -- CSA Medical announced on Thursday, the expansion of its truFreeze® label with the addition of Barrett's Esophagus with low grade dysplasia.  This expansion comes after 510(k) submission...

06:00
LOS ANGELES, Aug. 31, 2017 /PRNewswire-USNewswire/ -- As the largest private funder of childhood cancer research grants, the St. Baldrick's Foundation is proud to have contributed to the research and advocacy that led to the FDA approving the first...


30 août 2017

16:00
THOUSAND OAKS, Calif., Aug. 30, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) based on the overall survival (OS) data from...

14:57
WALTHAM, Mass., Aug. 30, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved a new cell therapy for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory...

13:49
EAST HANOVER, N.J., Aug. 30, 2017 /PRNewswire/ -- Novartis announced today that the US Food and Drug Administration (FDA) has approved Kymriahtm(tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, the first chimeric antigen...

12:58
RYE BROOK, N.Y., Aug. 30, 2017 /PRNewswire-USNewswire/ -- Today heralds a new era in cancer treatment with the U.S. Food and Drug Administration (FDA) approval of a new, cutting-edge gene therapy that reprograms a patient's immune system to find and...

12:06
PHILADELPHIA, Aug. 30, 2017 /PRNewswire/ -- In a landmark decision for the field of cancer immunotherapy, the U.S. Food and Drug Administration (FDA) today approved a personalized cellular therapy developed by the University of Pennsylvania and...

11:35
SILVER SPRING, Md., Aug. 30, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and...

06:45
INDIANAPOLIS, Aug. 30, 2017 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that, after discussions with the U.S. Food and Drug Administration (FDA) in late August, Lilly will resubmit the New...


29 août 2017

18:32
SILVER SPRING, Md., Aug. 29, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by...

17:04
SILVER SPRING, Md., Aug. 29, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved...

13:07
LOS ANGELES, Aug. 29, 2017 /PRNewswire/ -- Global Health Solutions, a Georgia based biotechnology company engaged in the development of novel, topical therapeutic agents for chronic wounds and dermatologic conditions, has announced FDA clearance of...

09:26
RIDGEFIELD, Conn., Aug. 29, 2017 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Cyltezotm, a biosimilar to Humira®, in a pre-filled syringe for the treatment of...

08:40
HAMPTON, Va., Aug. 29, 2017 /PRNewswire/ -- As of May 30, 2017, most U.S. importers of food and beverages are required to comply with the U.S. Food and Drug Administration's (FDA) Foreign Supplier Verification Program (FSVP) rule.  Registrar Corp is...

05:30
WETZLAR, Germany, Aug. 29, 2017 /PRNewswire/ -- Leica Microsystems is proud to be the first company to attain FDA 510(k) clearance for its FL560 fluorescence microscope filter for visualization of cerebrovascular blood flow in conjunction with the...


28 août 2017

09:24
SILVER SPRING, Md., Aug. 28, 2017 /PRNewswire-USNewswire/ -- One of the most promising new fields of science and medicine is the area of cell therapies and their use in regenerative medicine. These new technologies, most of which are in early stages...

09:00
ABBOTT PARK, Ill., Aug. 28, 2017 /PRNewswire/ -- Abbott (NYSE: ABT) announced today it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLevtm HeartMate 3tm Left Ventricular Assist System (also known as an LVAD). The...

08:48
RARITAN, N.J., Aug. 28, 2017 /PRNewswire/ -- Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, today announced that ORTHOtm Sera blood grouping reagents designed for extended phenotype testing has been licensed for...

02:09
TAIPEI, Taiwan and CINCINNATI, Aug. 28, 2017 /PRNewswire/ -- Lumosa Therapeutics Co., Ltd. ("Lumosa"), a Taipei-based biopharmaceutical company developing innovative therapies focused on the treatment of neurological and inflammatory disease,...


25 août 2017

12:18
PLAINSBORO, N.J., Aug. 25, 2017 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved a new indication for Victoza® (liraglutide) to reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in...

02:30
TOKYO, August 25, 2017 /PRNewswire/ -- Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151 President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") today announced that U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to...


24 août 2017

07:00
SOUTH SAN FRANCISCO, Calif., Aug. 24, 2017 /PRNewswire/ -- Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its ropinirole...


23 août 2017

08:00
PARAMUS, N.J., Aug. 23, 2017 /PRNewswire/ -- Epygenix Therapeutics, Inc., a privately held biopharmaceutical company developing precision medicine for rare and catastrophic forms of genetic epilepsy, announced today that the U.S. Food and Drug...


22 août 2017

08:45
JUPITER, Fla., Aug. 22, 2017 /PRNewswire/ -- Jupiter Orphan Therapeutics, Inc. ("JOT"), Jupiter, FL, today announced that it has received notification from the US Food and Drug Administration (FDA) that its Orphan Drug Designation request for...


21 août 2017

21:00
MOUNTAIN VIEW, California, August 22, 2017 /PRNewswire/ -- The experiment will examine the effectiveness of the MobiusHD implant in the reduction of blood pressure among chronic patients for whom at least three different medications proved...

16:05
HILDEN, Germany, GERMANTOWN, Maryland and BRIDGEWATER, New Jersey, August 21, 2017 /PRNewswire/ -- QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) and Clinical Genomics, a private company developing evidence-based diagnostic tools for...

10:03
LAKE OSWEGO, Ore., Aug. 21, 2017 /PRNewswire/ -- BIOTRONIK today announced FDA approval and commercial availability of Edora HF-T QP, an MR conditional quadripolar (QP) cardiac resynchronization therapy pacemaker (CRT-P) with MRI AutoDetect...

09:00
DUBLIN, Aug. 21, 2017 /PRNewswire/ -- Perrigo Company plc (NYSE; TASE: PRGO) today announced that it has received final approval from the U.S. Food & Drug Administration for the store brand OTC equivalent of Nexium® 24HR (esomeprazole magnesium)...


17 août 2017

18:41
AURORA, ON, Aug. 17, 2017 /CNW/ - Prollenium Medical Technologies Inc., a leading medical device manufacturer, announced today its United States (U.S.) Food and Drug Administration (FDA) approval for its cross-linked hyaluronic acid dermal filler....

15:51
SILVER SPRING, Md., Aug. 17, 2017 /PRNewswire-USNewswire/ -- As an additional measure in the fight against Zika virus, today the U.S. Food and Drug Administration announced that it has made available a panel of human plasma samples to aid in the...

13:54
SILVER SPRING, Md., Aug. 17, 2017 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia...

09:04
MAVIRET est le premier et le seul traitement pangénotypique d'une durée de huit semaines chez les patients atteints d'hépatite C qui sont exempts de cirrhose et qui reçoivent un traitement pour la première fois*1. L'approbation repose sur un taux de...

09:03
MAVIRET is the first and only 8-week, pan-genotypic treatment for hepatitis C patients without cirrhosis and who are new to treatment*1 The approval is supported by a 97 percent (n=639/657) cure** rate across GT1-6 patients without cirrhosis and who...

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