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» FDA Drug Safety Communication: Safety Review Update of Medications used to treat ADHD in children and young adults
The U.S. Food and Drug Administration (FDA) is updating the public that a large, recently-completed study in children and young adults treated with medication for Attention-Deficit/Hyperactivity Disorder (ADHD) has not shown an association between use of certain ADHD medications and adverse cardiovascular events.
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» FDA Drug Safety Communication: Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills containing drospirenone
The U.S. Food and Drug Administration (FDA) is continuing its review of the potential increased risk of blood clots with the use of birth control pills containing drospirenone.
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» FDA Drug Safety Communication: Voluntary market withdrawal of Xigris due to failure to show a survival benefit
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris [drotrecogin alfa (activated)].
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» FDA. New and Generic Drug Approvals - November 1, 2011
New drugs approved. List of drugs approved by FDA to date November 1, 2011
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» FDA. New and Generic Drug Approvals - October 31, 2011
New drugs approved. List of drugs approved by FDA to date October 31, 2011.
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» FDA. New and Generic Drug Approvals - October 28, 2011
New drugs approved. List of drugs approved by FDA to date October 28, 2011.
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» FDA. New and Generic Drug Approvals - October 27, 2011
New drugs approved. List of drugs approved by FDA to date October 27, 2011.
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» FDA. New and Generic Drug Approvals - October 26, 2011
New drugs approved. List of drugs approved by FDA to date October 26, 2011.
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» FDA. New and Generic Drug Approvals - October 25, 2011
New drugs approved. List of drugs approved by FDA to date October 25, 2011.
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» Data about Early Use and Long-Term Benefit of TYSABRI Presented at 5th Joint Triennial Congress of ECTRIMS and ACTRIMS
Biogen Idec and Elan Corporation, plc announced 28 company-supported TYSABRI (natalizumab) presentations at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS), held in Amsterdam, the Netherlands.
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» Quintiles Strengthens Late Phase Offerings with Acquisition of Outcome Sciences, Inc.
With late phase (Phase IIIB and Phase IV) research becoming increasingly important to multiple healthcare stakeholders, Quintiles announced it has acquired Outcome Sciences, Inc. (Outcome), a privately held outcomes research firm headquartered in Cambridge, Mass.
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» Alemtuzumab (Lemtrada) Significantly Reduces Relapses in Multiple Sclerosis vs Interferon Beta-1a in a Phase III Study
Sanofi and its subsidiary Genzyme announced new results from the CARE-MS I trial, the first of two randomized, Phase III clinical trials comparing the investigational drug alemtuzumab (Lemtrada) to Rebif
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» Oral Therapy Teriflunomide (Aubagio) Significantly Reduces Relapses Leading to Hospitalization of Patients with Multiple Sclerosis
Sanofi and its subsidiary Genzyme announced new data from the pivotal TEriflunomide Multiple Sclerosis Oral (TEMSO) Phase III trial showing that once-daily oral teriflunomide significantly reduced annualized rates of relapses leading to hospitalization.
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» EU study shows once-daily lisdexamfetamine dimesylate (LDX) effective for symptom control in children and adolescents with ADHD
Shire plc the global specialty biopharmaceutical company, presented positive top line results of the first European phase III study of once-daily lisdexamfetamine dimesylate (LDX) in children and adolescents aged 6 to 17 years with Attention-Deficit/Hyperactivity Disorder (ADHD).
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» Geron Presents Clinical Data Update from GRNOPC1 Spinal Cord Injury Trial
Geron Corporation announced two presentations on the company`s ongoing Phase 1 clinical trial of its human embryonic stem cell-based therapy, GRNOPC1, in patients with spinal cord injury.
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