Le Lézard

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

1 2 3 4 5 6 7 8 9 10

Aujourd'hui

10:00
PORTLAND, Ore., Oct. 15, 2018 /PRNewswire-PRWeb/ -- The Columbia-Inland Medical Pumper Car has been designated by the U.S. Food and Drug Administration (FDA) as non-measuring exercise device intended for medical purposes. Pumper Cars originally were...

09:00
Reflexion Health, the virtual rehabilitation therapy company, in conjunction with the Duke Clinical Research Institute (DCRI), today announced positive results from a randomized controlled clinical trial, "Virtual Exercise Rehabilitation In-home...


12 octobre 2018

16:15
AcelRx Pharmaceuticals, Inc. (AcelRx) , a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, announced today that the Anesthetic and Analgesic Drug Products Advisory Committee of the U.S. Food...

09:50
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, received approval  from the U.S. Food & Drug Administration (FDA) for its ID...

09:46
Transseptal Solutions Ltd. a mis au point un système d'accès transseptal innovant présentant une nouvelle approche de ponction transseptale et de navigation auriculaire gauche permettant d'introduire divers cathéters cardiovasculaires dans les...

08:00
Rockwell Medical, Inc. (the "Company" or "Rockwell Medical") today provided an update on the status of the Company's development of an intravenous ("IV") formulation of the Company's proprietary drug Triferic®, which is the only FDA-approved therapy...

07:00
Sutro Biopharma, Inc. , has been granted Orphan Drug Designation by the United States Food and Drug Administration (FDA) for STRO-001 for the treatment of multiple myeloma. STRO-001 is a potential first-in-class antibody drug conjugate (ADC)...


11 octobre 2018

16:56
The U.S. Food and Drug Administration today approved ID CORE XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility. The assay can be used to determine blood donor and patient non-ABO red blood cell (RBC)...

15:50
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved XARELTO® (rivaroxaban) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial...

11:15
Transseptal Solutions Ltd., developer of an innovative Transseptal Access System with a novel approach of transseptal puncture and left atrial navigation to introduce various cardiovascular catheters into the left heart chambers, announced today that...

09:01
MMS Holdings Inc. (MMS) ? an award-winning, data-focused CRO ? announced today their expert support to Paratek Pharmaceuticals, Inc. for the new drug application (NDA) approval and successful marketing authorisation application (MAA) filing of...

08:00
Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) approved new labeling for Stiolto Respimat (tiotropium bromide & olodaterol) Inhalation Spray that includes data showing a meaningful reduction in COPD...

08:00
Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced that the Journal of Drugs in Dermatology has published results of two identical Phase...


10 octobre 2018

08:30
SpineEX, Inc., a medical device company that aims to provide innovative and minimally invasive implants, high-value disposables and instrumentation for spinal fusion surgeries, announced today it has received 510(k) clearance from the U.S. Food and...


9 octobre 2018

11:15
Vapotherm, Inc. (Vapotherm), a leader in advanced respiratory technology, today announced that the U.S. Food and Drug Administration (FDA) has granted Vapotherm's latest version of the Precision Flow® product, the Precision Flow Hi-VNItm system, a...


8 octobre 2018

07:00
Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, one of the...


5 octobre 2018

17:08
The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years....

16:00
Coordination Pharmaceuticals, Inc. (CPI), a privately held and clinical-stage biopharmaceutical company focused on nanotechnology-based cancer immunotherapy, announced today that the U.S. Food and Drug Administration (FDA) has approved the Company's...

14:30
Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Roflumilast Tablets, 500mcg, generic for Daliresp® Tablets by AstraZeneca...

13:48
The U.S. Food and Drug Administration today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first...

11:01
Today, the Medical Technology business group of ZEISS announced the FDA Premarket Approval (PMA) for ReLEx® SMILE® PMA expanding myopia treatment to patients with astigmatism. The PMA also provides for a small entry incision to be made, allowing the...

08:35
EAS Consulting Group is honored to announce that Dean Cirotta, EAS President and COO, was an invited key speaker to the September 29, 2018 Fourth Session of the SIDS DOCK Assembly ? the Sustainable Energy and Climate Resilience Organization, at the...


4 octobre 2018

07:30
Allergan plc today announced that the CoolSculpting® treatment received FDA clearance to treat the submandibular area. In addition, the FDA clearance was expanded to include patients with a BMI of up to 46.2 when treating the submental and...


3 octobre 2018

11:06
CarboFix in Orthopedics LLC., has announced today that the U.S. Food and Drug Administration (FDA) has cleared its CarboClear® Carbon Fiber Transverse Connectors to be used in conjunction with its Carbon Fiber Pedicle Screw System, a novel device to...

08:00
PARI Pharma GmbH, a company focused on the development and commercialization of advanced aerosol delivery systems based on eFlow Technology, announces approval of its optimized eFlow technology nebulizer LAMIRAtm together with Insmed's ARIKAYCE®...


2 octobre 2018

09:00
Processa Pharmaceuticals, Inc. , a clinical stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have high unmet medical need conditions, announced today that the U.S. Food and Drug...

08:07
Today QOL Medical, LLC announced that the U.S. Food and Drug Administration (FDA) has approved the company's wholly owned manufacturing facility in Clearwater, Florida to manufacture sacrosidase, the drug substance used to make Sucraid® (sacrosidase)...

06:07
QOL Medical, LLC today announced that the U.S. Food and Drug Administration (FDA) has approved its new, state-of-the-art manufacturing facility in Florida. The supply of Sucraid® (sacrosidase) Oral Solution has been restored. QOL Medical, LLC is now...


1 octobre 2018

09:00
Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for KYPROLIS® (carfilzomib) to include a once-weekly dosing option in combination...

08:32
Infinity Pharmaceuticals, Inc. announced today that it earned a $22 million payment from Verastem Oncology under the license agreement between the Company and Verastem for COPIKTRA (duvelisib).  The payment was earned upon the approval by the U.S....


29 septembre 2018

23:00
Innovent Biologics, Inc. (Innovent), a world-class China-based biopharmaceutical company that develops high quality drugs, announced yesterday that its IND application for IBI-188, a fully human anti-CD47 monoclonal antibody (mAb) drug candidate, has...


28 septembre 2018

17:22
The U.S. Food and Drug Administration today approved a new drug, Arikayce (amikacin liposome inhalation suspension), for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex (MAC) in a limited population of...

16:51
The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for...

16:39
Libtayo is the third anti-PD-1 approved in the U.S. CSCC is the second most common skin cancer in the U.S. Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Libtayo®...

16:29
Today the U.S. Food and Drug Administration permitted marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a...

14:54
Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) expanded the indication of its antiepileptic drug FYCOMPA® (perampanel) CIII for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of...

08:00
TransThera Biosciences Co. Ltd, announced today that the company received FDA IND application approval for TT-00420, a novel small molecule investigational drug targeting Triple-Negative Breast Cancer (TNBC). TT-00420 is a selectively clustered...


27 septembre 2018

19:52
Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved Emgalitytm (galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in adults.1 Emgality offers a once-monthly,...

16:05
Sandoz Inc. today announced that the US Food and Drug Administration has approved SYMJEPItm (epinephrine) 0.15 mg Injection for the emergency treatment of allergic reactions in children. Sandoz will distribute and commercialize SYMJEPItm...

12:49
HighTide Therapeutics Inc., a globally focused clinical-stage biopharmaceutical company, announced that the U.S. FDA has granted Fast Track Designation to its investigational new drug, HTD1801, for the treatment of patients with primary sclerosing...

08:00
Profounda, Inc. ("Profounda") announced today that it has received the US Food and Drug Administration's Competitive Generic Therapy (CGT) Designation for the planned future ANDA filing of Minocycline Hydrochloride Microspheres, 1 mg, pursuant to...


26 septembre 2018

09:59
IDx, the company that has developed the first and only FDA-cleared autonomous AI diagnostic system, has secured significant venture capital funding to accelerate market adoption and further develop additional diagnostic systems for its AI platform....

08:38
OrthoXeltm is a specialist orthopaedic trauma company, using innovative engineering design to evolve truly next generation fracture fixation devices. OrthoXeltm is delighted to announce that the new Apex Femoral Nailing System has been granted US FDA...

07:30
Allergan plc , a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's supplemental New Drug Application (sNDA) for VRAYLAR® (cariprazine), seeking to expand the...

06:00
INSIGHTEC®,a global medical technology innovator of incisionless surgery, today announced that the U.S. Food and Drug Administration (FDA) has approved Exablate Neurotm compatibility for the state-of-the-art MRI Scanners Magnetom Skyra, Prisma and...

05:00
Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Tesera® X Lateral Interbody Fusion System. Tesera X is the latest...

02:00
Aronora Inc., a clinical stage biotechnology company developing first-in-class treatments for life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for proCase (E-WE thrombin,...


25 septembre 2018

06:30
The privately-owned company, MT.DERM GmbH, Berlin, Germany, a manufacturer of medical microneedling, micropigmentation and tattoo equipment is excited to announce its expansion into the US market of its medical microneedling device, Exceed under the...


24 septembre 2018

08:00
Alnylam Pharmaceuticals, Inc. , the leading RNA interference (RNAi) therapeutics company, announced today that Health Canada has granted Priority Review status to patisiran. Priority review is granted to regulatory filings in Canada intended for new...

06:45
Today, Boston Scientific announced that the U.S. Food and Drug Administration (FDA) has approved its Premarket Approval (PMA) application to market the Eluviatm Drug-Eluting Vascular Stent System, specifically developed for the treatment of...

1 2 3 4 5 6 7 8 9 10