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 The leading web portal for pharmacy resources, news, education and careers September 30, 2016
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - September 30, 2016

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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9/28/16 - U.S. Food and Drug Administration Approves ORKAMBI (lumacaftor/ivacaftor) for Use in Children with Cystic Fibrosis Ages 6 through 11 who have Two Copies of the F508del Mutation
Vertex Pharmaceuticals Incorporated today announced that the U.S. Food and Drug Administration approved ORKAMBI for use in children with cystic fibrosis ages 6 through 11 who have two copies of the F508del mutation. With today s approval, approximately 11,000 people with CF are eligible for treatment with ORKAMBI in the United States.
9/27/16 - Aesthetic Lasers Market Is Forecasted To Grow At A CAGR of Around 15.5% By 2024: Hexa Reports
"Get key Market Research Reports and Insightful Company Profiles" In April 2016, Oculus Innovative Sciences, Inc. received the FDA approval for Microcyn-based Lasercyn Gel, intended for post-non-ablative laser therapy procedures management The " Global Aesthetic Lasers Market" is expected to reach USD 1.8 billion by 2024, according to a new report
9/27/16 - Asterias Biotherapeutics Announces Dosing of First Patient in New SCiSTAR Clinical Trial Cohort Testing AST-OPC1 in an Expanded Cervical Spinal Cord Injury Patient Population
Asterias Biotherapeutics, Inc., a biotechnology company pioneering the field of regenerative medicine, today announced that the first patient with incomplete AIS-B cervical spinal cord injury was successfully dosed with 10 million cells of AST-OPC1 in the SCiSTAR clinical trial at Shepherd Center in Atlanta. The company recently received FDA clea
9/27/16 - FDA Approves STELARA (Ustekinumab) for Treatment of Adults With Moderately to Severely Active Crohn's Disease
Release date- 26092016- Horsham, Pa- Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration has approved STELARA for the treatment of moderately to severely active Crohn's disease in adults who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necr
9/27/16 - Markey Calls on FTC to Fully Investigate Suboxone Drugmaker for Antitrust Violations
Washington- With 78 Americans losing their lives everyday due to prescription painkiller and opioid overdoses, Senator Edward J. Markey today called on the Federal Trade Commission to investigate Indivior, the manufacturer of the drug Suboxone, for antitrust violations. In 2002, the Food and Drug Administration granted Indivior exclusive rights to
9/27/16 - Medtronic's StealthStation Cranial Software Receives FDA Clearance as an Aid for Deep Brain Stimulation Lead Placement
Release date- 26092016- DUBLIN and SAN DIEGO- Medtronic plc today announced U.S. Food and Drug Administration clearance of StealthStation Cranial Software as an aid for deep brain stimulation lead placement. The software is fully integrated with Medtronic's latest O-arm Imaging System, providing clinicians with a complete procedural solution for th
9/27/16 - U.S. FDA Approves Labeling Update of REXULTI(brexpiprazole) for Maintenance Treatment of Schizophrenia in Patients in the U.S.
Release date- 26092016- 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 in patients in the U.S.. The approval was based on results from a long-term rand
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 - Allergan Receives FDA Approval to Market Natrelle Inspira Breast Implants
Allergan plc announces it has received approval from the US Food and Drug Administration (FDA) to market Natrelle Inspira Cohesive breast implants, the latest entry in the gummy category of implants.
9/26/16 - BrainScope Announces FDA Clearance of the First Handheld Medical Device for Assessment of the Full Spectrum of Traumatic Brain Injury [Saudi Press Agency (Saudi Arabia)]
Developed in partnership with the U.S. Department of Defense, the Ahead 300 provides a multi-modal device of clinically relevant measures, offering clinicians a comprehensive panel of data to assist in their diagnosis of the full spectrum of TBI, including concussion. The Ahead 300 represents an evolution from the three BrainScope products that hav
9/26/16 - CompactCath Unveils the World's Most Discreet FDA-Cleared Catheter
CompactCath, a medical device company committed to improving the quality of life for people with bladder conditions, has today unveiled its flagship intermittent urinary catheter designed to address the most common frustrations of regular catheter users. The FDA-Cleared device will be available today through various distributors including 180...
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 - FDA approves Amjevita, a biosimilar to Humira
Release date- 23092016- 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 J
9/26/16 - FDA Approves STELARA (ustekinumab) For Treatment Of Adults With Moderately To Severely Active Crohn's Disease
Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration has approved STELARA for the treatment of moderately to severely active Crohn's disease in adults who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor blocker, or who fail
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
9/26/16 - Novartis receives three new FDA approvals for the expanded use of Ilaris treating rare Periodic Fever Syndrome conditions
Release date- 23092016- Basel- Novartis announced today that the US Food and Drug Administration has granted three simultaneous approvals for the expanded use of Ilaris to treat three rare and distinct types of Periodic Fever Syndromes. Ilaris is the first and only FDA approved biologic treatment for Tumor Necrosis Factor-Receptor Associated Period
9/26/16 - Opsens receives 510(k) clearance for the OptoMonitor II providing extended indication
-Opsens Inc. announces 510 clearance from the U.S. Food and Drug Administration for the OptoMonitor II, a new multimodality monitor combining the ability to measure Fractional Flow Reserve along with measuring intravascular and intracatheter pressure. In the United States, Opsens already sells its products to measure FFR for the diagnostic and trea
9/26/16 - Roche receives 510(k) clearance from FDA for Treponema pallidum assay to aid clinicians in the diagnosis of syphilis infection
Roche announced today that it has received 510 clearance from the U.S. Food and Drug Administration for a fully automated assay for the detection of antibodies to Treponema pallidium for use on all Roche immunoassay systems for low-, mid- and high-volume testing environments, including the cobas e 411, cobas e 601, cobas e 602 and MODULAR ANALYTI
9/26/16 - U.S. FDA APPROVES LABELING UPDATE OF REXULTI (brexpiprazole) FOR MAINTENANCE TREATMENT OF SCHIZOPHRENIA*
Release date- 23092016- Princeton, New Jersey and 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
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
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