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 The leading web portal for pharmacy resources, news, education and careers September 26, 2016
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - September 26, 2016

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 53     Next >>     Go To Page:

9/26/16 - AbbVie Announces Submission of a Supplemental New Drug Application for Ibrutinib (IMBRUVICA) for Treatment of Marginal Zone Lymphoma
AbbVie, a global biopharmaceutical company, today announced that it submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for ibrutinib to treat patients with marginal zone lymphoma. IMBRUVICA is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc.. "We continue t
9/26/16 - FDA Approves AMGN's 1st Biosimilar, MRNS On Track, All Ears For DRRX, PTIE
BASEL- The FDA on Friday approved Amgen's AMJEVITA, a biosimilar to AbbVie's Humira, across all eligible indications. AMJEVITA, which is Amgen's first biosimilar to receive the FDA nod, has been approved for the treatment of seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile...
9/26/16 - Ibrutinib (IMBRUVICA) Supplemental New Drug Application Submitted to the U.S. Food and Drug Administration (FDA) for Marginal Zone Lymphoma (MZL)
The filing is based on data from the multi-center, open-label Phase 2 PCYC-1121 trial assessing the use of ibrutinib, a BTK inhibitor, in patients with MZL who have received at least one prior therapy. IMBRUVICA is jointly developed and commercialized by Janssen and Pharmacyclics LLC, an AbbVie company. "We are encouraged by the results of this st
9/26/16 - Medtronic's StealthStation Cranial Software Receives FDA Clearance as an Aid for Deep Brain Stimulation Lead Placement
The Company Continues to Pioneer Innovations in Deep Brain Stimulation and Surgical Technologies by Launching the Only Fully-Integrated Procedural Solution for Neurosurgery DUBLIN and SAN DIEGO- September 26, 2016- Medtronic plc today announced U.S. Food and Drug Administration clearance of StealthStation Cranial Software as an aid for deep brai
9/25/16 - FDA approves first-line cervical cancer screen test
It can concurrently detect 12 other types of high-risk HPVs, according to the FDA. The FDA recommended that women who test positive for HPV 16 or HPV 18 using the cobas HPV test have a colposcopy. "They conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening
9/25/16 - FDA Okays Amgen's AMJEVITA For Treatment Of Seven Inflammatory Diseases
THOUSAND OAKS- Amgen said that the U.S. Food and Drug Administration has approved AMJEVITA or adalimumab-atto across all eligible indications of the reference product, Humira or adalimumab. AMJEVITA is Amgen's first biosimilar to receive regulatory approval. Biosimilar adalimumab is one of nine programs included in Amgen's robust pipeline of...
9/24/16 - FDA approves Amjevita, a biosimilar to Humira [Palestine Chronicle, The]
The U.S. Food and Drug Administration today approved Amjevita as a biosimilar to Humira for multiple inflammatory diseases. This is the fourth FDA- approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions, said Janet Woodcock, M.D., direc
9/24/16 - FDA Approves Expanded Use Of Ilaris To Treat 3 Rare Periodic Fever Syndromes
BASEL- Novartis announced that the US Food and Drug Administration or FDA has granted three simultaneous approvals for the expanded use of Ilaris to treat three rare and distinct types of Periodic Fever Syndromes: Tumor Necrosis Factor-Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome/ Mevalonate Kinase Deficiency and Familial...
9/24/16 - US FDA approves labeling update of Rexulti (brexpiprazole) for maintenance treatment of schizophrenia [Saudi Election]
-Labeling update includes clinical data on use of Rexulti in adult patients with schizophrenia in the maintenance phase of treatment. Valby, Denmark and Princeton, New Jersey, 23 September 2016- H. Lundbeck A/S and Otsuka Pharmaceutical Development& Commercialization, Inc. announced today that the US Food and Drug Administration approved the labeli
9/23/16 - Additive Orthopaedics Announces the 510k Clearance of Their 3D Printed Osteotomy Wedge System for the Global Extremities Market
By a News Reporter-Staff News Editor at Health& Medicine Week Additive Orthopaedics, LLC., an early stage orthopaedic device company, announced that is has received FDA 510 clearance for its 3 D printed osteotomy wedge system, to address bone fractures or osteotomies in the foot and ankle. This is the Company's second innovative device leveraging
9/23/16 - Allergan Announces FDA Approval of NATRELLE INSPIRA Cohesive Breast Implants
Allergan plc today announced the company has received approval from the U.S. Food and Drug Administration to market NATRELLE INSPIRA Cohesive breast implants, offering women undergoing reconstruction, augmentation or revision surgery a new breast shaping option that combines a high gel fill ratio and Allergan's highly cohesive gel 1,2 for a...
9/23/16 - Carestream's OnSight 3D Extremity System Receives FDA 510k Clearance
By a News Reporter-Staff News Editor at Health& Medicine Week The CARESTREAM OnSight 3 D Extremity System that uses cone beam CT technology to capture weight-bearing and other types of extremity exams has received FDA 510 clearance and is available for order in the United States. "Our extremity imaging system can help in treating a host of ortho
9/23/16 - Cepheid's Xpert TV Now Cleared For Testing Symptomatic And Asymptomatic Men
By a News Reporter-Staff News Editor at Genomics& Genetics Weekly Men in the United States can now have easier access to fast and accurate testing for a potentially dangerous sexually transmitted infection, thanks to expanded claims allowed by the Food and Drug Administration for the Xpert TV assay by Cepheid, a sensitive urine-based test for Tri
9/23/16 - FDA Approves Amgen's AMJEVITA? (Adalimumab-Atto) For Treatment Of Seven Inflammatory Diseases
Amgen today announced that the U.S. Food and Drug Administration has approved AMJEVITA? across all eligible indications of the reference product, Humira . AMJEVITA is Amgen's first biosimilar to receive regulatory approval. In addition, AMJEVITA holds the potential to offer patients with chronic inflammatory diseases an additional treatment o
9/23/16 - FDA approves Amjevita, a biosimilar to Humira
The U.S. Food and Drug Administration today approved Amjevita as a biosimilar to Humira for multiple inflammatory diseases. "This is the fourth FDA- approved biosimilar. The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions, "said Janet Woodcock, M.D., di
9/23/16 - FDA approves lower-cost alternative to biotech drug Humira
WASHINGTON Federal regulators on Friday approved the first alternative version of the second-best selling drug in the world, Humira, the blockbuster injection used to treat rheumatoid arthritis and other inflammatory diseases.
9/23/16 - GNW-News: Novartis receives three new FDA approvals for the expanded use of Ilaris treating rare Periodic Fever Syndrome conditions (english)
Novartis receives three new FDA approvals for the expanded use of Ilaris treating rare Periodic Fever Syndrome conditions. Novartis International AG/ Novartis receives three new FDA approvals for the expanded use of Ilaris treating rare Periodic Fever Syndrome conditions. Basel, September 23, 2016- Novartis announced today that the US Food and Drug
9/23/16 - Novartis receives three new FDA approvals for the expanded use of Ilaris treating rare Periodic Fever Syndrome conditions
Novartis International AG/ Novartis receives three new FDA approvals for the expanded use of Ilaris treating rare Periodic Fever Syndrome conditions. *Ilaris is the first and only US FDA- approved biologic treatment for patients with TRAPS, HIDS/MKD and FMF disease* These three simultaneous approvals conducted under FDA Priority Review follow...
9/23/16 - Tactile Medical Receives FDA 510(k) Clearance for New Indication of At-Home Lymphedema Treatment [Tripoli Post, The (Libya)]
-Tactile Systems Technology, Inc., a medical technology company that develops and provides innovative medical devices for the treatment of chronic diseases at home, announced today that it has received 510 clearance from the U.S. Food and Drug Administration for the Flexitouch System in treating lymphedema of the head and neck, a common consequence
9/23/16 - U.S. FDA Approves Labeling Update of REXULTI (brexpiprazole) For Maintenance Treatment of Schizophrenia
PRINCETON, N.J.& VALBY, Denmark Otsuka Pharmaceutical Development& Commercialization, Inc. and H. Lundbeck A/S announced today that the U.S. Food and Drug Administration approved the labeling update of REXULTI to reflect clinical data for maintenance treatment of schizophrenia. There are approximately 2.4 million adults in the U.S. with s
9/23/16 - US FDA approves labeling update of Rexulti (brexpiprazole) for maintenance treatment of schizophrenia
Valby, Denmark, 2016-09-24 00:30 CEST. Valby, Denmark and Princeton, New Jersey, 23 September 2016- H. Lundbeck A/S and Otsuka Pharmaceutical Development& Commercialization, Inc. announced today that the US Food and Drug Administration approved the labeling update of Rexulti to reflect clinical data for maintenance treatment of schizophrenia.
9/23/16 - US FDA gives tentative approval for Aurobindo`s generic HIV drug [Palestine Chronicle, The]
Aurobindo Pharma Limited announced on Thursday that it has received tentative approval from the US Food and Drug Administration for Dolutegravir 50 mg. This is the first FDA approval for a generic version of Dolutegravir, an integrase inhibitor recommended for use in treatment of HIV patients by the US Centers for Disease Control and Prevention and
9/23/16 - ViewRay Receives Chinese Regulatory Approval for its MRIdian System
By a News Reporter-Staff News Editor at Drug Week ViewRay, Inc. announced that the company has received China Food and Drug Administration approval for its MRIdian System, the world's first and only clinical MRI-guided radiation therapy system. "China is one of the largest markets for medical devices in the world, so securing CFDA approval is an
9/23/16 - Zeiss VisuMax Laser Now Approved for All Laser LASIK & SMILE Vision Correction
For Bernard Milstein, M.D. of The Eye Clinic of Texas, the Food and Drug Administration (FDA) approval of the Zeiss VisuMax Laser for SMILE Laser Vision Correction of Nearsightedness is another "tool" in his refractive surgery "toolbox."
9/22/16 - Aurobindo Pharma to launch HIV drug in Africa this year, gets tentative FDA nod [Cyprus Mail]
Aurobindo Pharma Limited, a pharmaceutical manufacturing company based in Hyderabad, said it received a tentative approval for HIV drug Dolutegravir from US Food& Drug Administration. Further, we are also developing a fixed dose combination of DTG, said N. Govindarajan, Managing Director of Aurobindo Pharma Limited. ViiV Healthcare and Aurobindo Ph
Articles(s): 1 - 25 of 53     Next >>     Go To Page:


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