Le Lézard

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

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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...

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...

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