Le Lézard

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

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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...

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
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...

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