Le Lézard

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

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29 mai 2018

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...

04:00
FAST TRACK AND BREAKTHROUGH DESIGNATIONS BY THE FDA AND FIRST U.S. NARCOLEPSY PATIENTS INCLUDED IN AN EXPANDED ACCESS PROGRAM Bioprojet is pleased to share the following announcement from their partner Harmony Biosciences, LLC (Harmony) who received...

04:00
UN ACCES ACCELERE ET UN STATUT DE MEDICAMENTINNOVANT DECERNES PAR LA FDA ,ET DES PREMIERS PATIENTS NARCOLEPTIQUES INCLUS DANS UN PROGRAMME D'ACCES ELARGI AUX ETATS UNIS  Bioprojet est très heureux de  vous faire part de  l'annonce  de son...


21 mai 2018

16:45
Breckenridge Pharmaceutical, Inc. announced today the supplemental approval for the 40mg strength of Duloxetine Delayed-Release Capsules. The U.S. Food and Drug Administration granted final approval for the Supplemental Abbreviated New Drug...

16:00
Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the use of Prolia® (denosumab) for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture, defined as a history of...

12:19
The Department of Ear Nose & Throat/Allergy at Summit Medical Group was part of a clinical trial that led the U.S. Food & Drug Administration (FDA) to approve XHANCEtm (fluticasone proprionate), a nasal spray for the treatment of nasal polyps in...

11:19
The U.S. Food and Drug Administration today approved Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. This is the...

09:00
WAT Medical's leading product to treat nausea-induced vomiting, EmeTerm, has received its FDA clearance earlier in April. Now ready to officially enter the U.S. market as an effective medical treatment. WAT Medical is thrilled to bringing its...

08:35
CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EMBOTRAP II Revascularization Device, a next generation stent retriever used to...

08:30
Nestlé Skin Health, a global leader focused on meeting the world's increasing skin health needs, announced today that the U.S. Food and Drug Administration (FDA) has approved the hyaluronic acid (HA) dermal filler Restylane® Lyft for the correction...

08:00
Zavante Therapeutics, Inc., a biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients, today announced that the company and its research collaborators will present seven posters related to...

06:53
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 Dronabinol Capsules USP, 2.5 mg, 5 mg and 10 mg, the therapeutic equivalent to the...


17 mai 2018

19:15
The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment...

19:11
Novartis today announced that the US Food and Drug Administration (FDA) has approved Aimovigtm (erenumab-aooe) for the preventive treatment of migraine in adults. Aimovig is a novel therapeutic approach as the first and only FDA-approved treatment...

19:04
Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved Aimovigtm (erenumab-aooe) for the preventive treatment of migraine in adults. Aimovig is a novel therapeutic approach as the first and only FDA-approved treatment...

09:15
Amneal Pharmaceuticals, Inc. , a specialty pharmaceutical company, today announced it has received final U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application for a generic version of Welchol® (colesevelam HCI)...


16 mai 2018

17:55
US WorldMeds today announced that the US Food and Drug Administration (FDA) approved LUCEMYRA (lofexidine) for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. The FDA reviewed LUCEMYRA under Priority...

16:22
The U.S. Food and Drug Administration today approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While Lucemyra may lessen the severity of withdrawal...

15:28
Additive Orthopaedics, LLC., the leader in 3D printed orthopaedic foot and ankle devices, today announced that is has received FDA 510(k) clearance for its Patient Specific 3D Printed Bone Segments, to address internal bone fixation in the ankle and...

08:30
Castle Creek Pharmaceuticals (CCP), a global company dedicated to delivering transformative therapies to patients with orphan dermatologic and other underserved conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted...


15 mai 2018

11:56
The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV...

10:53
On May 10, 2018, Xcaliber International, Ltd., L.L.C. ("Xcaliber"), a Pryor, Oklahoma based cigarette manufacturer, received 15 orders from the U.S. Food and Drug Administration, Center for Tobacco Products ("FDA") finding certain tobacco products...

09:00
Medic Vision Imaging Solutions, Ltd., the leading innovator of vendor-independent solutions for CT and MRI scanners, today announced that the U.S. Food and Drug Administration (FDA) has cleared its latest product, iQMRtm (intelligent Quick MR)....

09:00
Caliber Imaging & Diagnostics Inc. (Caliber I.D.) announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for modifications to its VIVASCOPE® System. The VIVASCOPE System is an industry-leading reflectance...

07:00
Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for expanded claims for Xpert® Carba-R, an on-demand molecular test for rapid and accurate detection of carbapenemase-producing Gram-negative...


14 mai 2018

09:00
Allium Medical - an Israeli medical device company that specializes in minimally invasive technologies and solutions, announced today that it received regulatory clearance from the China Food and Drug Administration (CFDA) to market its portfolio...

08:00
Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, today announced the expansion of its blood typing solutions portfolio in the...

07:00
CurveBeam announced it has received FDA 510(k) clearance for its LineUP Multi-extremity weight bearing CT system. The compact system enables radiologists and orthopedic specialists to visualize three-dimensional bone...

01:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today FDA approval of an additional claim for the cobas® Zika test for use on the cobas® 6800/8800 Systems.  The newly approved claim allows for the streamlined screening of multiple individual blood or...


11 mai 2018

18:35
Novartis today announced that the US Food and Drug Administration (FDA) has approved Gilenya® (fingolimod) for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis, making it the first...

16:28
The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in pediatric patients. ...

16:01
Perrigo Company plc today announced that it expects to receive a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its Abbreviated New Drug Application (ANDA) for its generic version of ProAir® (albuterol sulfate)...


9 mai 2018

16:05
AcelRx Pharmaceuticals, Inc. , (AcelRx), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today reported its first quarter 2018 financial results. "The first quarter of this year was...


8 mai 2018

09:02
Acutus Medical®, a global heart rhythm technology company, today announced that the AcQMap® High Resolution Imaging and Mapping System has been utilized for the first time in U.S. patients. The company also revealed initiation of a new clinical study...

08:00
Debiopharm International SA (Debiopharm - www.debiopharm.com), part of Debiopharm Grouptm, a Swiss-based global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to...

08:00
Debiopharm International SA (Debiopharm - www.debiopharm.com), membre de Debiopharm Grouptm, une société pharmaceutique basée en Suisse, a annoncé aujourd'hui que la Food and Drug Administration des États-Unis (FDA) a accordé la désignation...

07:59
AstraZeneca today announced Health Canada's approval for Lynparza® (olaparib) tablets, as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed (PSR), high-grade epithelial ovarian, fallopian tube or primary...

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