Le Lézard

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

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11 juin 2018

09:00
Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add the positive overall survival (OS) data from the Phase 3 ASPIRE trial to the U.S. Prescribing Information for...

08:15
OrthoSensor, Inc., a leader in sensor-assisted technology for total knee replacement (TKR), today announced it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for its VERASENSE* Sensor-Assisted Technology (VERASENSE) to...


10 juin 2018

23:27
Cellenkostm, Inc., a clinical-stage biotechnology company, today announced that the United States Food and Drug Administration has cleared the Investigational New Drug (IND) application which allows for Cellenkostm to proceed with a phase I clinical...


8 juin 2018

14:55
AbbVie , a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved, under priority review, VENCLEXTA® (venetoclax tablets) in combination with rituximab for the treatment of patients...


7 juin 2018

10:24
Amerigen Pharmaceuticals Limited ("Amerigen") today announced the commercial launch of its generic bexarotene 75mg capsules following the recent approval of the Company's corresponding Abbreviated New Drug Application ("ANDA") by the U.S. Food and...

10:00
Centinel Spine, LLC is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its FLXtm Platform of Integrated Interbodytm and non-integrated interbody fusion devices.  Centinel Spine is...

08:00
DarioHealth Corp. , a leading global digital health company with mobile health and big data solutions, announced today it has experienced a successful launch of its iPhone® 7, 8 and X compatible Blood Glucose Monitoring System following FDA...


6 juin 2018

07:54
Commercial-stage cancer biotech company, Partner Therapeutics, Inc. (PTx), announced the recent FDA approval of Leukine for the treatment of adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome...


5 juin 2018

09:00
Royal Philips , a global leader in health technology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Ingenia Elition 3.0T MR solution and two clinical applications, Philips Compressed...

06:45
Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new indication for ALIMTA® (pemetrexed for injection) in combination with carboplatin and KEYTRUDA® (pembrolizumab) for the initial...


4 juin 2018

16:58
The U.S. Food and Drug Administration today approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia (fever, often with other signs of...

16:52
Mylan N.V. and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's Fulphilatm (pegfilgrastim-jmbd), a biosimilar to Neulasta® (pegfilgrastim), co-developed with Biocon....

11:00
Micronics, Inc. has announced today that its test for the detection of Shiga toxin-producing E. coli (STEC) has received clearance from the U.S. Food and Drug Administration. The Micronics PanNAT STEC Test is performed in a disposable...

09:00
Rodo Medical, Inc., an innovative dental device company, announces FDA 510(k) clearance of the Rodo Smilekey, an induction remover device for use with the Rodo Abutment System.  The Smilekey uses Rodo's proprietary induction technology to remove...

08:41
AutoGenomics, Inc., based in Carlsbad, CA, announced that its INFINITI® Neural Response Panel has been granted designation as a Breakthrough Device by the US Food and Drug Administration (FDA).  The INFINITI® Neural Response Panel is a qualitative...

08:00
Camber Spine today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ENZAtm-A Titanium Anterior Lumbar Interbody Fusion (ALIF) system, a unique, minimally invasive interbody fusion device...

07:10
Palatin Technologies, Inc. , a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, announced today that the U.S. Food and...


1 juin 2018

16:45
Asymchem, a leading custom manufacturer of Intermediates and API's for the life sciences industry, today announced that its Fuxin 1 site, a dedicated carbapenem manufacturing facility, successfully passed the U.S. Food and Drug Administration (USFDA)...

12:04
Eli Lilly and Company and Incyte Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved the 2-mg dose of OLUMIANT® (baricitinib), a once-daily oral medication for the treatment of adults with...

09:23
Apobiologix, a division of Apotex Inc., further bolstered its leadership in Canada's growing biosimilar market. The company that is focused on the development of biosimilars for global markets, recently received approval from Health Canada for...

08:30
Aratana Therapeutics, Inc. , a pet therapeutics company focused on the licensing, development and commercialization of innovative therapeutics for dogs and cats, today announced the Company submitted a supplemental New Animal Drug Application (NADA)...

06:52
Lannett Company, Inc. today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Levofloxacin Oral Solution USP, 25 mg/mL, the therapeutic equivalent to the reference...


31 mai 2018

12:12
Following the receipt of two Complete Response Letters from the FDA related to manufacturing issues, Pfizer's Retacrit was finally cleared for marketing authorization.  Retacrit is the first biosimilar ESA to become available in the US....

11:20
Branchpoint Technologies, a company dedicated to providing accurate, reliable and cost-effective mobile solutions for intracranial pressure (ICP) monitoring, announced that the United States Food and Drug Administration (FDA) has granted 510(k)...

10:00
MicroVention, Inc., a U.S.-based subsidiary of Terumo and a global neurovascular company, announced today the FDA Premarket Approval (PMA) for the LVIS® and LVIS® Jr. stents for stent-assisted coil embolization of intracranial aneurysms. The LVIS®...

09:00
Global biotherapeutics leader CSL Behring today announced that the US Food and Drug Administration (FDA) has approved a 3500 IU (international unit) vial size for IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein (rFIX-FP)], its...

08:15
Nektar Therapeutics  today announced submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for NKTR-181, a new molecular entity (NME) and the first analgesic opioid molecule to exhibit a reduced incidence of...


30 mai 2018

15:26
The U.S. Food and Drug Administration today approved the first stand-alone prosthetic iris in the United States, a surgically implanted device to treat adults and children whose iris (the colored part of the eye around the pupil) is completely...

12:26
The U.S. Food and Drug Administration today expanded the approval of Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis. Xeljanz is the first oral medication approved for chronic use in this indication....

09:59
Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Priority Review for its antiepileptic drug FYCOMPA® (perampanel) CIII for monotherapy and adjunctive use for the...

09:37
TherapeuticsMD, Inc. , an innovative women's healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved IMVEXXYtm (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal...

08:00
Legend Biotech, a subsidiary of GenScript Biotech Corporation (HKEx: 1548), announced today that the U.S. Food and Drug Administration (FDA) has authorized its development partner, Janssen Biotech, Inc. ("Janssen"), to commence a Phase 1b/2 clinical...

07:15
Amneal Pharmaceuticals, Inc. , a specialty pharmaceutical company, today announced it has received U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application (ANDA) for Cyclophosphamide for Injection USP, the Company's...

07:00
Pursuit Vascular, Inc., manufacturer of ClearGuard HD Antimicrobial Caps, the leading antimicrobial device for catheter-based dialysis patients, today announced that the U.S. Food and Drug Administration (FDA) granted clearance for a broader...


29 mai 2018

09:00
TrioxBio Inc., a clinical-stage biopharmaceutical company specializing in the development of drugs to treat diseases and medical conditions related to the pathological overproduction of nitric oxide (NO), today announced that the U.S. Food and Drug...

08:30
Zeto, Inc., a privately held medical technology company transforming the way electroencephalography (EEG) is done at hospitals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its dry electrode EEG...

08:00
The U.S. Food and Drug Administration's (FDA) approval of CIMZIA® (certolizumab pegol) for use in moderate-to-severe plaque psoriasis marks the entry of UCB into immuno-dermatology CIMZIA Phase 3 psoriasis studies demonstrated significant and...

06:45
Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) submitted by its collaboration partner Loxo Oncology, Inc. , and granted Priority Review for larotrectinib for the treatment of adult...


24 mai 2018

18:22
The U.S. Food and Drug Administration today approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU). Patients with PKU are born with an inability to break down phenylalanine (Phe), an...

17:42
BioMarin Pharmaceutical Inc. today announced that BioMarin received standard approval from the U.S. Food and Drug Administration (FDA) for Palynziqtm (pegvaliase-pqpz) Injection to reduce blood phenylalanine (Phe) concentrations in adult patients...

11:00
AGC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, announced today that it will supply bulk drug substance for the launch of Portola Pharmaceuticals' Andexxa® [coagulation factor Xa (recombinant),...

11:00
AGC Biologics, leader mondial en production clinique et commerciale de protéines thérapeutiques, a annoncé aujourd'hui qu'elle fournira une substance médicamenteuse en vrac pour le lancement d'Andexxa® de Portola Pharmaceuticals [facteur Xa de...

00:05
Samsung BioLogics announced today that a third monoclonal antibody Drug Substance has been licensed by the US FDA (Food and Drug Administration) for its second plant, the world's largest single plant. With the approval, Samsung BioLogics has been...


23 mai 2018

09:00
Abbott today announced it received approval from the U.S. Food and Drug Administration (FDA) for XIENCE SierraTM, the newest generation of the company's gold-standard XIENCE everolimus-eluting coronary stent system. XIENCE stents are among the...

08:00
Bio Products Laboratory Limited (BPL), a leading manufacturer of plasma-derived protein therapies, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (BLA) for...

07:34
BERG, LLC, a Boston-based biopharmaceutical company that merges biology with technology to map the nature of diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation for the Company's lead product...


22 mai 2018

14:06
CrossRoads® Extremity Systems, the Global Leader in Active Stabilizationtm, offering innovative foot & ankle fixation implant systems and services, announced that the Company has received FDA clearance for the DynaFORCE® Active Stabilizationtm MPJ...

08:30
Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved a label update for Taltz® (ixekizumab) injection 80 mg/mL to include data in psoriasis involving the genital area.1 Taltz is the first and only...

08:01
The U.S. Food and Drug Administration (FDA) has accepted Sanofi's regulatory filing for Zynquista (sotagliflozin). The investigational oral treatment would be used in addition to insulin therapy to improve blood sugar control in adults with type 1...

06:00
Providence Medical Technology, Inc., a manufacturer of innovative instruments and implants for cervical fusion surgery, today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its DTRAX® Spinal...

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