Regulatory and Drug Approvals News
Regulatory Affairs and Drug Approvals News
FDA Approves Embryonic Stem Cell-Based Therapy For Patients With Acute Spinal Cord Injury
Regulatory and Drug Approvals News
The US FDA (Food and Drug Administration) has lifted a clinical hold on Geron's Investigational New Drug (IND) application - the Phase I clinical trial of GRNOPC1 in patients with acute spinal cord injury may now go ahead. GRNOPC1 is the first ever clinical trial of a human embryonic stem cell based therapy in humans...
Eisai Announces U.S. Fda Approval For New Higher Dose Aricept® 23 Mg Tablet For The Treatment Of Moderate-To-Severe Alzheimer's Disease
Biotechnology news Pharma Industry News Regulatory and Drug Approvals News
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) announced that its U.S. subsidiary Eisai Inc. has received approval from the U.S. Food and Drug Administration (FDA) for Aricept® (generic name: donepezil hydrochloride) 23 mg once daily tablet for the treatment of moderate-to-severe Alzheimer's disease (AD)...
GSK Receives CHMP Positive Opinion For A New Indication For Arixtra
Biotechnology news Pharma Industry News Regulatory and Drug Approvals News
GlaxoSmithKline (GSK) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Arixtra (fondaparinux),an anti-clotting drug (antithrombotic) for the treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis (SVT) of the lower limbs without concomitant deep-vein thrombosis...
FDA Approves Vaccines For The 2010-2011 Influenza Season
The U.S. Food and Drug Administration announced that it has approved vaccines for the 2010-2011 influenza season in the United States. Seasonal influenza vaccine protects against three strains of influenza, including the 2009 H1N1 influenza virus, which caused the 2009 pandemic...
Hotspur Technologies Receives FDA 510(k) Clearance For First Three Product Lines Based On The Company's Unique Technology
Hotspur Technologies, Inc. announced that it has received FDA clearance for the first three commercial products in its portfolio. These products are based on Hotspur's unique and groundbreaking technology that makes dialysis access interventional and peripheral vascular procedures that open blood vessels less expensive, more efficient, and less invasive for patients...
NICE Gives Green Light To MabThera(R) (Rituximab) For Wider Use In Patients With Most Common Chronic Leukaemia
The National Institute for Health and Clinical Excellence (NICE) extended its recommendation for the use of targeted antibody MabThera® (rituximab) to include people with relapsed and difficult-to-treat (refractory) chronic lymphocytic leukaemia (CLL) except where patients have received the full therapeutic dose of MabThera in the first line setting or are refractory to fludarabine...
AdvanDx Receives FDA 510(k) Clearance For 90 Minutes Protocol For Yeast Traffic Light® PNA FISH®
AdvanDx announced that it has received FDA 510(k) clearance for a fast, 90 minutes protocol for its Yeast Traffic Light® PNA FISH® test. The faster protocol reduces the PNA FISH turn-around time from the original 2.5 hours to 90 minutes by reducing PNA probe hybridization from 90 minutes to 30 minutes...
Shionogi Inc. Announces FDA Approval Of CUVPOSA™ For The Treatment Of Chronic Severe Drooling In Pediatric Patients With Neurologic Conditions
Shionogi Inc., a U.S.-based group company of Shionogi & Co., Ltd., announced the U.S. Food and Drug Administration approval of CUVPOSA™ (glycopyrrolate), the first liquid treatment for patients ages 3-16 who suffer from chronic severe drooling associated with neurologic conditions such as cerebral palsy. CUVPOSA™ was designated an Orphan Drug by the FDA...
Boston Scientific Announces FDA Approval Of New Leads For The Precision Plus™ Spinal Cord Stimulator System
Boston Scientific Corporation (NYSE: BSX) announced U.S. Food and Drug Administration approval of two spinal cord stimulation (SCS) leads for use with its Precision Plus™ Spinal Cord Stimulator System, the world's first rechargeable SCS device for the management of chronic pain of the trunk and/or limbs...
ACT Files Documentation With FDA For Clinical Trials Using ES Cells To Treat Eye Disease.
Advanced Cell Technology, Inc...
Advanced Life Sciences Applies For FDA Fast-Track Designation For Restanza In CABP
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced that the Company has applied to the U.S...
Abbott's SIMCOR ® ( Niacin Extended-release / Simvastatin ) Receives FDA Approval For New Dosage Strengths
Abbott (NYSE: ABT) received U.S. Food and Drug Administration (FDA) approval for two new dosage strengths of SIMCOR®, a cholesterol medication. The new SIMCOR dosage strengths combine 40 mg of simvastatin the most commonly prescribed dose of simvastatin with either 500 mg or 1,000 mg of niacin extended-release...
Encap Drug Delivery Receives Patent Approval For DuoCapTM Capsule System
Encap Drug Delivery, a leading provider of development and manufacturing services to the pharmaceutical industry, has received confirmation that their DuoCapTM, capsule delivery system has been granted patents for US and Europe. DuoCapTM, is a single oral dosage unit that comprises a capsule-in-a-capsule and offers broad therapeutic applications...
Mapping NTDs Is Critical For Controlling, Treating Diseases
Mapping neglected tropical diseases (NTDs) is vital for efforts to control and treat diseases, write the authors of an editorial published Tuesday in PLoS Neglected Tropical Diseases, ANI/Sindh Today reports (7/28)...
Abbott's SIMCOR(R) (Niacin Extended-Release / Simvastatin) Receives FDA Approval For New Dosage Strengths
Abbott received U.S. Food and Drug Administration (FDA) approval for two new dosage strengths of SIMCOR®, a cholesterol medication. The new SIMCOR dosage strengths combine 40 mg of simvastatin - the most commonly prescribed dose of simvastatin - with either 500 mg or 1,000 mg of niacin extended-release...
Abraxis BioScience And Specialised Therapeutics Announce Approval To Market ABRAXANE For Metastatic Breast Cancer In New Zealand
Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, and Specialised Therapeutics Ltd. today announced that MEDSAFE, the New Zealand Medicines and Medical Devices Safety Authority, has approved for marketing ABRAXANE® (nanoparticle albumin-bound paclitaxel) for the treatment of metastatic breast cancer after failure of anthracycline therapy...
Abbott's SIMCOR ® ( Niacin Extended-release / Simvastatin ) Receives FDA Approval For New Dosage Strengths
Abbott (NYSE: ABT) received U.S. Food and Drug Administration (FDA) approval for two new dosage strengths of SIMCOR®, a cholesterol medication. The new SIMCOR dosage strengths combine 40 mg of simvastatin the most commonly prescribed dose of simvastatin with either 500 mg or 1,000 mg of niacin extended-release...
Advanced Life Sciences Applies For FDA Fast-Track Designation For Restanza In CABP
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced that the Company has applied to the U.S...
FDA Approves Drug For Chronic Drooling In Children
The U.S. Food and Drug Administration approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years. Drooling is normal in infants. But a significant proportion of the developmentally disabled population experiences drooling caused primarily by neuromuscular dysfunction that makes it hard to swallow...
New Early Detection System Helps FDA Identify More Than 100 Food Safety Problems In First 7 Months
More than 100 food safety reports were submitted by industry to the U.S. Food and Drug Administration's new electronic portal in its first months of operation, the agency said today...
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