Le Lézard

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

1 septembre 2017

08:30
ANI Pharmaceuticals, Inc. ("ANI") today announced that it has received approval from the U.S. Food and Drug Administration ("FDA") of its Abbreviated New Drug Application ("ANDA") for Oxycodone Hydrochloride Oral Solution USP, 100 mg/5 mL (20...


31 août 2017

10:39
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 approved by the FDA to treat Chagas disease.      (Logo:...

09:45
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 approved by the FDA to treat Chagas disease.      (Logo:...

08:14
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 of clinical data supporting the use of truFreeze Spray...

06:00
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 gene therapy treatment in the U.S. for children with...


30 août 2017

16:00
Amgen 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 the Phase 3 head-to-head ENDEAVOR trial demonstrating that...

14:57
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 or in second or later relapse. The Novartis...

13:49
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 receptor T cell (CAR-T) therapy, for the treatment of...

12:58
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 kill cancer cells.  This highly personalized therapy known...

12:06
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 Children's Hospital of Philadelphia (CHOP) for...

11:35
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 other serious and life-threatening diseases....

06:45
Eli Lilly and Company and Incyte Corporation announced today that, after discussions with the U.S. Food and Drug Administration (FDA) in late August, Lilly will resubmit the New Drug Application (NDA) for baricitinib before the end of January 2018....


29 août 2017

18:32
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 specific bacteria. Vabomere is a drug containing meropenem, an...

17:04
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 in the United States for the treatment of Chagas disease....

13:07
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 AtopXtm Emulsion, indicated for the...

09:26
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 multiple chronic inflammatory diseases, including:...

08:40
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 aware that importers have begun receiving...

05:30
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 dye fluorescein. When integrated into a M530 OH6...


28 août 2017

09:24
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 of development, hold significant promise for transformative...

09:00
Abbott 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 HeartMate 3 system provides a new option for physicians managing...

08:48
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 commercialization in the United States by the U.S....

02:09
Lumosa Therapeutics Co., Ltd. ("Lumosa"), a Taipei-based biopharmaceutical company developing innovative therapies focused on the treatment of neurological and inflammatory disease, announced today the FDA has confirmed the 505(b)(2) regulatory...


25 août 2017

12:18
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 adults with type 2 diabetes and established CV...

02:30
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 their investigational product,...


24 août 2017

07:00
Titan Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its ropinirole implant intended for treatment of the signs and symptoms of Parkinson's...


23 août 2017

08:00
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 Administration has granted Orphan Drug Designation...


22 août 2017

08:45
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 trans-Resveratrol has been granted. "Orphan Drug...


21 août 2017

21:00
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 ineffective.  The objective of this innovative development is to...

16:05
QIAGEN and Clinical Genomics, a private company developing evidence-based diagnostic tools for colorectal cancer, today announced they have implemented the PAXgene® Blood ccfDNA Tube* sample collection in Clinical Genomics' Colveratm colorectal...

10:03
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 technology. With a volume of...

09:00
Perrigo Company plc 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) capsules. The company also announced that it has reached a...


17 août 2017

18:41
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. Ario Khoshbin, Founder and CEO,...

15:51
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 regulatory evaluation of serological tests to detect recent Zika...

13:54
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 (ALL). "For adult patients with...

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
AbbVie , a global biopharmaceutical company, today announced...


16 août 2017

12:08
US FDA has granted two orphan drug designations (ODD) for T cell therapy products to Singapore-based biotech company, Lion TCR Pte Ltd, for the treatment of hepatocellular carcinoma (HCC). Lion TCR are developing two product candidates -- HBV...

08:51
Perrigo Company plc today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing Mycolog® II Cream (nystatin and triamcinolone acetonide cream USP, 100,000...

02:51
Medivir AB announces today that the Investigational New Drug (IND) application for MIV-711 has been accepted and the IND is now open with the FDA (U.S. Food and Drug Administration). "We are very pleased to have received FDA acceptance for our IND....


15 août 2017

08:08
Camber Spine Technologies announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SPIRAtm Open Matrix ALIF device, a unique, interbody fusion implant consisting of spiral support arches and...


11 août 2017

16:31
The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Major...

09:30
Renovis Surgical Technologies, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market posterior lumbar Tesera® porous titanium interbody fusion systems....

07:00
Ionis Pharmaceuticals, Inc. today reported that the Company has retained all rights to inotersen and IONIS-FB-LRx. As part of a reprioritization of its pipeline and strategic review of its Rare Diseases business, GSK declined its options on both...


9 août 2017

11:02
InDex Pharmaceuticals Holding AB (publ) today announced that the US Food and Drug Administration (FDA) has granted orphan-drug designation for the drug candidate cobitolimod for treatment of ulcerative colitis in pediatric patients. "We are pleased...

07:15
Ocugen, Inc., a clinical stage biopharmaceutical company developing novel treatments for sight-threatening diseases, today announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for OCU300 (brimonidine...


8 août 2017

10:32
AUM Cardiovascular announced that it has received clearance from the Food and Drug Administration for CADence,tm a non-invasive acoustic and ECG device designed to help physicians detect physiological and pathological heart murmurs....

08:30
Mitsubishi Tanabe Pharma America, Inc., today announced RADICAVA tm (edaravone), an intravenous therapy indicated for all adult patients diagnosed with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is now available for...

08:08
The Scottish Medicines Consortium (SMC) has announced today a positive decision for the use of NOQDIRNA®.[1] NOQDIRNA® is the only licensed treatment for the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults,...


7 août 2017

16:17
Valeant Pharmaceuticals International, Inc. today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution,...

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...