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 The leading web portal for pharmacy resources, news, education and careers August 14, 2018
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - August 14, 2018

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 89     Next >>     Go To Page:

8/14/18 - Amicus Galafold wins US approval [Sudan Tribune]
Amicus Therapeutics Galafold has been approved in the US as the first oral medication for the treatment of adults with Fabry disease. Galafold was approved using the Accelerated Approval pathway, which allows the US Food and Drug Administration to approve drugs for serious conditions where there is an unmet medical need if a treatment drug is shown
8/14/18 - Amicus oral Fabry disease drug approved in US [Arab News (Saudi Arabia)]
Amicus Therapeutics first oral drug for the rare condition Fabry disease has been approved by the FDA, giving patients an alternative to conventional injected enzyme replacement therapy. The oral drug is an alternative to the infused enzyme replacement therapy that is current standard of care Sanofi/ Genzymes Fabarazyme. Already approved in Europe,
8/14/18 - Arbutus LNP Licensee Alnylam Announces FDA Approval of ONPATTRO (patisiran), for the Treatment of ATTR Amyloidosis [Sport360]
Arbutus Biopharma Corporation, an industry-leading Hepatitis B Virus therapeutic solutions company, today announced that the Company`s lipid nanoparticle licensee, Alnylam Pharmaceuticals, Inc., announced that their new drug application for ONPATTRO, an RNAi therapeutic, has been approved by the U.S. Food and Drug Administration for the treatment o
8/14/18 - Department of Labor recommending a revolutionary multi-modal medical device 'Neurolumen' for pain relief
Oklahoma City, OK Forget high doses of pain killer medications for pain relief. The American Department of Labor has finally found a better and safer alternative for injured employees suffering from persistent and physically limiting pain. The innovative device has received approval from both FDA and Intertek and was covered by Reader's Digest a
8/14/18 - Department of Labor recommending a revolutionary multi-modal medical device Neurolumen for pain relief
It works on all types of pain. Oklahoma City, OK- August 13, 2018- Forget high doses of pain killer medications for pain relief. The American Department of Labor has finally found a better and safer alternative for injured employees suffering from persistent and physically limiting pain. The innovative device has received approval from both FDA and
8/14/18 - FDA Approvals for Cardiac Electrophysiology Products Bright Spot in Healthcare Industry
Active healthcare stocks in news today include: BioSig Technologies, Inc., electroCore, Inc., Boston Scientific Corporation, Abbott Laboratories, Johnson& Johnson. BioSig Technologies, Inc. BREAKING NEWS- BioSig Technologies announced that the Company has received 510 clearance for its first product, PURE EP System, from the U.S. Food and Drug Admi
8/14/18 - FDA approves Amicus` Galafold for Fabry disease [T-break Tech (Middle East)]
The efficacy of Galafold was demonstrated in a six-month, placebo-controlled clinical trial in 45 adults with Fabry disease. The U.S. Food and Drug Administration recently approved Galafold, the first oral medication for the treatment of adults with Fabry disease. Galafold differs from enzyme replacement in that it increases the activity of the bod
8/14/18 - FDA approves app as a form of birth control [T-break Tech (Middle East)]
There have never been so many choices when it comes to birth control, and now the US Food and Drug Administration has approved a&# x2018; digital contraceptive&# x2019; for the first time.&# xA0;. Natural Cycles has been approved as a contraceptive method since 2017 in the European Union, but it&# x2019; s taken a little longer for the US to get on
8/14/18 - First ever RNA-based gene-silencing drug approved by FDA, and it`s not cheap [All Iraq News Agency (AIN)]
Twenty years after the breakthrough discovery illustrating how RNA interference can be used to silence certain genes, and over a decade after the research won a Nobel prize, the U.S. Food and Drug Administration has approved the first drug utilizing this method for adult clinical treatment. The condition, hereditary transthyretin-mediated amyloidos
8/14/18 - Genmab Announces Submission of U.S. & EU Regulatory Applications Seeking Approval of DARZALEX Split Dosing Regimen
Copenhagen- Genmab A/S announced today that its licensing partner, Janssen Biotech, Inc., has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration and a Type II Variation to the European Medicines Agency seeking approval of a split dosing regimen for DARZALEX. In August 2012, Genmab granted Janssen an excl
8/14/18 - GI Dynamics Announces FDA Approval for EndoBarrier Pivotal Trial [Tehran Times (Iran)]
GI Dynamics Inc., a medical device company that is developing EndoBarrier for patients diagnosed with type 2 diabetes and obesity, is pleased to announce it has received approval of an investigational device exemption from the U.S. Food and Drug Administration to begin enrollment in a pivotal trial evaluating the safety and efficacy of EndoBarrier
8/14/18 - Glenmark Pharmaceuticals' partner Elite Pharmaceuticals receives US FDA approval for generic methadone hydrochloride tablets
NORTHVALE- Elite Pharmaceuticals, Inc., a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today announced that it received approval from the U.S. Food and Drug Administration for the Company's abbreviated new drug application for methadone hydrochloride 5 mg and 10 mg tablets. Based on QuintilesIMS...
8/14/18 - Inova Diagnostics Receives FDA Clearance for Test to Detect Antibodies to HMGCR
Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is pleased to announce the clearance of QUANTA Flash HMGCR by the US Food and Drug Administration. HMGCR is a marker exclusively available from Inova Diagnostics, and is one of 30 FDA- cleared assays available on BIO-FLASH , a
8/14/18 - Janssen Submits U.S. & EU Regulatory Applications Seeking Approval of DARZALEX Split Dosing Regimen
RARITAN- The Janssen Pharmaceutical Companies of Johnson& Johnson announced today the submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration and a Type II Variation to the European Medicines Agency seeking approval of a split dosing regimen for DARZALEX. In the U.S., DARZALEX first received FDA approval
8/14/18 - Procleix Zika Virus Assay Approved by the FDA for Blood Screening on the Procleix Panther System
Grifols, a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, today announced that the U.S. Food and Drug Administration approved the Procleix Zika Virus assay for the detection of the virus in individual or pooled plasma specimens from human donors, including volunteer donor
8/14/18 - VRTX - FDA Approves ORKAMBI as First Medicine to Treat the Underlying Cause of Cystic Fibrosis for Children Ages 2-5 Years with Most Common Form of the Disease
BOSTON- Vertex Pharmaceuticals Incorporated today announced the U.S. Food and Drug Administration has approved ORKAMBI to include use in children ages 2 through 5 years with cystic fibrosis who have two copies of the F508del-CFTR mutation, making it the first medicine approved to treat the underlying cause of CF in this population. 'For the first t
8/13/18 - 7D Surgical Receives FDA Approval For Cranial Surgery
7 D Surgical announced today that it has received 510 clearance from the U.S. Food and Drug Administration for its Cranial Module. This achievement is a crucial step in the commercial launch of 7 D Surgical's innovative Machine-vision Image Guided Surgery system for cranial surgery throughout the United States. Faster, better and cheaper is the n
8/13/18 - Advanced Cardiac Therapeutics, Inc. Changes Name to EPIX Therapeutics, Inc.
Advanced Cardiac Therapeutics, Inc., a medical device company that designs and manufactures a catheter-based system for the treatment of patients with atrial fibrillation, today announced it has changed its name to EPIX Therapeutics, Inc.. Founded in 2007, the company has pioneered the development of catheter ablation solutions for the treatment
8/13/18 - Alynlam Pharma Receives FDA Approval for Onpattro
On Friday, Alnylam Pharmaceuticals received US Food and Drug Administration approval for Onpattro.. Are You Aware of the FDA's Plans for 2018? Alnylam also announced on Friday the pricing for the drug and a new pricing guarantee.
8/13/18 - Amicus' Galafold wins accelerated approval from FDA
Amicus said the U.S. approval is the first for a new Fabry disease therapy in more than 15 years. Amicus plans to launch Galafold immediately in the U.S., and intends to reveal its U.S. price during an Aug. 13 conference call. In 2016, the company slowed Galafold's U.S. development timeline, saying FDA did not consider changes in GL-3 to be a basis
8/13/18 - Arbutus LNP Licensee Alnylam Announces FDA Approval of ONPATTRO (patisiran), for the Treatment of ATTR Amyloidosis
Arbutus Biopharma, an industry-leading Hepatitis B Virus therapeutic solutions company, today announced that the Company s lipid nanoparticle licensee, Alnylam Pharmaceuticals,, announced that their new drug application for ONPATTRO, an RNAi therapeutic, has been approved by the U.S. Food and Drug Administration for the treatment of hereditary A
8/13/18 - Arbutus LNP Licensee Alnylam Announces FDA Approval of ONPATTRO? (patisiran), for the Treatment of ATTR Amyloidosis
Arbutus Biopharma Corporation, an industry-leading Hepatitis B Virus therapeutic solutions company, today announced that the Company's lipid nanoparticle licensee, Alnylam Pharmaceuticals, Inc., announced that their new drug application for ONPATTRO, an RNAi therapeutic, has been approved by the U.S. Food and Drug Administration for the treatment
8/13/18 - FDA Approves Contraceptive Vaginal Ring That Can Be Used for a Year [Sudan Tribune]
On Friday, August 10, the US Food and Drug Administration approved the first-ever contraceptive vaginal ring that can be used for up to a full year, BuzzFeed News reports. The product, called Annovera, was developed by the non-profit organization Population Council, which recently partnered with TherapeuticsMD, a pharmaceutical company, in order to
8/13/18 - FDA approves first consumer app for contraceptive use
The U.S. Food and Drug Administration for the first time has approved marketing of a mobile app as a contraception method to prevent pregnancy. Terri Cornelison, assistant director for the health of women in the FDA's Center for Devices and Radiological Health, said in a press release Friday. The app costs $79.99 per year and includes an oral basal
8/13/18 - FDA approves its first RNA-based treatment for a rare disease [Syrian Arab News Agency]
This is also the first FDA- approved treatment for this rare, debilitating and often fatal genetic disease characterized by the buildup of abnormal amyloid protein in peripheral nerves, the heart and other organs. "This approval is part of a broader wave of advances that allow us to treat disease by actually targeting the root cause, enabling us t
Articles(s): 1 - 25 of 89     Next >>     Go To Page:


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