Le Lézard

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

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1 novembre 2017

08:45
IntraFuse, a start-up medical device company focused on advanced surgical devices for improving outcomes for orthopaedic extremity procedures, announces that it has received FDA 510(k) clearance for its FlexThreadtm Fibula Pin System. The IntraFuse...

08:30
The U.S Food and Drug Administration is taking advantage of latest policy guidance spelled out in past years to speed drug approvals. Thirty-four new drug products and advanced medicines, treating everything from cancer to rare genetic diseases, have...


31 octobre 2017

16:05
Luminex Corporation today announced that it has received FDA clearance for the ARIES® Group A Strep Assay, a moderate complexity, sample to answer test for the direct detection of Streptococcus pyogenes from throat swab specimens using the ARIES®...

15:54
Avella announced that it has been selected by AstraZeneca to distribute CALQUENCE® (acalabrutinib), a Bruton tyrosine kinase (BTK) inhibitor indicated for patients with mantle cell lymphoma (MCL) who have received at least one prior...

14:54
AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to CALQUENCE® (acalabrutinib). CALQUENCE is a kinase...

12:08
The U.S. Food and Drug Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. "Mantle cell...

11:03
Award-winning medical technology company EYE TECH CARE has received approval from the China Food and Drug Administration (CFDA) to begin marketing its EyeOP1® glaucoma treatment product in China. The first non-invasive medical device approved for...

09:00
Abbott has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its Alinitytm ci-series instruments for clinical chemistry and immunoassay diagnostics. These innovative testing solutions were designed to help the lab more effectively...

09:00
BRH Medical, a medical device company developing and marketing innovative products for increasing blood flow and pain reduction, announced today that it has received 510 (k) clearance from the US Food and Drug Administration ("FDA") for its...

08:45
The FDA has approved 34 drugs to date in 2017 after approving 22 novel drugs last year. Many biotech and pharma companies have dealt with the drug development process being lengthy and time-consuming along with requiring the utilization of a lot of...


30 octobre 2017

09:15
Equashield (http://www.equashield.com), a leading provider of Closed System Transfer Devices (CSTDs) for hazardous drugs, announced today that its Spanish distributor, Palex Medical, will expand distribution of Equashield's CSTDs through its...

08:00
Janssen Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration (FDA) approved the 10 mg once-daily dose of XARELTO® (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism (VTE) after completing at...


26 octobre 2017

23:30
Veeda Clinical Research is glad to share the successful completion of 2 USFDA Inspections at 2 of its locations at Ahmedabad in Sep-2017. Both the Inspections were Routine Inspections by BIMO (BioResearch Monitoring Program - USFDA) covering Clinical...

09:00
Nitiloop, a medical device company dedicated to the development of Cardiovascular and peripheral microcatheters for complex lesions, received FDA clearance for its new Nova Crosstm Extreme and Nova Crosstm BTK. These dedicated microcatheters are...

08:07
Hologic, Inc. announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Panther Fusion® Paraflu assay, a multiplexed assay which runs on the new Panther Fusion® system. ...


25 octobre 2017

16:24
Agenus Inc. , an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted in...

07:00
Prometic Life Sciences Inc. (Prometic) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PBI-4050, a clinical candidate in development for idiopathic pulmonary fibrosis (IPF). The Fast Track...

07:00
Prometic Sciences de la Vie inc. (« Prometic » ou la « Société ») a annoncé aujourd'hui avoir obtenu une désignation accélérée de la Food and Drug Administration américaine (« FDA ») pour le PBI-4050, un médicament candidat en...

02:38
Swedish Orphan Biovitrum AB (publ) (Sobitm) today announces that the Saudi Food & Drug Authority (SFDA) in the Kingdom of Saudi Arabia has approved Alprolix® (eftrenonacog alfa), for the treatment of haemophilia B.  Alprolix is the first extended...


24 octobre 2017

09:20
Ortek Therapeutics, Inc. today announced that the Ortek ECDtm received 510(k) clearance from the U.S. Food and Drug Administration. The ECD is a patented lightweight tabletop device designed as an aid for dental professionals to diagnose and monitor...

09:08
Perrigo Company plc today announced it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for the generic version of Picato® Gel (ingenol mebutate) 0.015%. The submission date of Perrigo's Abbreviated New Drug...

08:03
Acutus Medical® today announced that the U.S. Food and Drug Administration has cleared the AcQMap® High Resolution Imaging and Mapping System and the AcQMap® 3D Imaging and Mapping...

06:00
Denovo Biopharma, a leader in precision medicine, announced today that the US Food and Drug Administration (FDA) has granted DB102 the Investigational New Drug application (IND) clearance to proceed for a phase 3 trial to treat Diffuse Large B Cell...


23 octobre 2017

16:57
Neurocrine Biosciences, Inc. today announced that valbenazine, a novel selective vesicular monoamine transporter 2 (VMAT2), has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of pediatric...

16:01
Impax Laboratories, 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 ("ANDA") for a generic version of Renvela® (sevelamer...

09:00
Abbott has secured U.S. Food and Drug Administration (FDA) clearance for the Confirm Rxtm Insertable Cardiac Monitor (ICM), the world's first and only smartphone compatible ICM designed to help physicians remotely identify cardiac arrhythmias. With...

06:00
United Therapeutics Corporation today announced approval by the U.S. Food and Drug Administration (FDA) of a new inhalation device, called the TD-300/A, for use with Tyvaso® (treprostinil) Inhalation Solution (Tyvaso). Tyvaso was originally...


20 octobre 2017

19:16
GlaxoSmithKline plc [LSE/NYSE: GSK] today announced that the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 50 years and older....

19:00
Agenus Inc. , an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that the US Food and Drug Administration (FDA) granted marketing authorization to GlaxoSmithKline's (GSK) herpes zoster...

16:23
Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI ARIA® (golimumab), the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion, for the...

06:00
Taiho Pharma Canada, Inc., a Canadian subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), today announced that Health Canada accepted for review Taiho's New Drug Submission (NDS) for trifluridine (FTD) and tipiracil (TPI), and that the NDS has been...

06:00
Taiho Pharma Canada, Inc., une filiale canadienne de Taiho Pharmaceutical Co., Ltd. (Japon), a annoncé aujourd'hui que Santé Canada avait accepté aux fins d'examen sa Présentation de drogue nouvelle (PDN) pour trifluridine (FTD) en combinaison avec...


19 octobre 2017

13:36
Nexus Pharmaceuticals announced today the immediate availability in the United States of Procainamide HCL Injection, USP. Nexus Pharmaceuticals' Procainamide HCL Injection, USP is available as a multi dose vial containing 1,000 mg per 2 mL (500...

12:37
Merck, une société de science et de technologie de premier ordre, a annoncé aujourd'hui que son unité de...

07:19
SafeTraces, Inc., a San Francisco Bay Area based company that provides ground-breaking food source assurance solutions, announced that it completed a $6.5 million Series A financing round. Omidyar Network led the investment round with participation...

06:30
BioLife Solutions, Inc. , the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media ("BioLife" or the "Company"), today announced that its customer Kite...

02:00
Merck, a leading science and technology company, today announced that its Carlsbad, California-based manufacturing facility for the production of...


18 octobre 2017

19:36
The Leukemia & Lymphoma Society (LLS) hails today's U.S. Food and Drug Administration (FDA) approval of a new, personalized cell therapy that supercharges the patient's immune system to find and kill cancer cells. The therapy, axicabtagene ciloleucel...

19:13
The Food and Drug Administration announced today the approval of Yescartatm (Axicabtagene ciloleucel), a revolutionary new immunotherapy for adult patients with diffuse large B cell lymphoma, a form of non-Hodgkin's lymphoma. Yescarta is a Chimeric...

17:56
The U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two...

17:34
Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) voted 16-0, supporting the approval of once-weekly semaglutide to improve glycemic control in adults...

08:45
The small business compliance deadline for the U.S. Food and Drug Administration (FDA) Preventive Controls Rule for Human Food passed on September 18, 2017.  Under the Foreign Supplier Verification Program (FSVP) Rule, many U.S. importers have six...

08:45
Biotech Briefing: The Biotech Sector continues to impress and even surprise many as the SPDR S&P Biotech ETF (XBI) has surged 49 percent in 2017 to its highest level in more than two years and some industry professionals believe the climb isn't over...

08:00
Respiratory Motion, Inc., announced today its plans to launch the newest version of its ExSpiron 1Xitm Minute Ventilation (MV) Monitor at the American Society of Anesthesiologists (ASA) in Boston, October 21-25 following recent FDA 510(k) clearance....

07:00
OptiScan Biomedical Corporation, a developer of innovative continuous monitoring systems for use in the surgical intensive care unit (SICU), today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the...


17 octobre 2017

10:07
Unequal®, a leading manufacturer of sports protective gear, announced that the Food and Drug Administration has determined that Unequal's patented HART® CC Pad device, found in every Unequal HART chest protector, can improve safety on the playing...


16 octobre 2017

09:00
Stryker's Joint Replacement division today announced that its cementless Mako Total Knee with Triathlon Tritanium has received 510(k) market clearance by the U.S. Food and Drug Administration. Triathlon Tritanium...

08:30
NuVasive, Inc. , a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced an expanded U.S. Food and Drug Administration (FDA) 510(k) clearance of the...

08:30
Instrumentation Laboratory (IL) today announced the 510(k) clearance of the HemosIL AcuStar HIT-IgG(PF4-H) Assay and HemosIL AcuStar HIT Controls by the US Food and Drug Administration (FDA).  The HemosIL AcuStar HIT-IgG(PF4-H) Assay is the first...


13 octobre 2017

16:20
Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for STELARA® (ustekinumab) for the treatment of adolescents (12 years of age or older) with moderate to severe plaque...

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