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 The leading web portal for pharmacy resources, news, education and careers January 20, 2018
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - January 20, 2018

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 51     Next >>     Go To Page:

1/20/18 - Avera To Enroll First Patients in Landmark Lung Cancer Tri-Therapy Clinical Trial [Sudan Tribune]
This clinical trial that received the approval of the FDA is Averas latest collaboration as part its membership in the Worldwide Innovative Networking Consortium. This latest step in our collaboration with WIN represents one clinical trial but is part of our larger goal to revolutionize cancer care through personalized medicine, said Benjamin Solom
1/19/18 - AstraZeneca Announces Approval Of Fasenra In Japan
LONDON- AstraZeneca and MedImmune announced the Japanese Ministry of Health, Labour and Welfare has approved Fasenra as an add-on treatment for bronchial asthma in patients who continue to experience asthma exacerbations despite treatment with high-dose inhaled corticosteroid and other asthma controllers. The Japanese approval follows US FDA...
1/19/18 - Avera To Enroll First Patients in Landmark Lung Cancer Tri-Therapy Clinical Trial
This clinical trial that received the approval of the FDA is Avera s latest collaboration as part its membership in the Worldwide Innovative Networking Consortium. Through the WIN Consortium, an Avera research team under Solomon s leadership has helped design and implement the clinical trial from the ground up. This breakthrough research i
1/19/18 - Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
SUMMARY: The Food and Drug Administration is announcing the availability of a guidance for industry entitled "Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503 B of the Federal Food, Drug, and Cosmetic Act." For a drug product compounded by an outsourcing facility to qualify for the exemptions under se
1/19/18 - EC approves Amgen's biosimilar Avastin
Amgen Inc. and Allergan plc said the European Commission approved Mvasi, a biosimilar of Avastin bevacizumab. In September, FDA approved the drug as Mvasi bevacizumab-awwb for all cancer types on Avastin's U.S. label except ovarian cancer. Roche and its Genentech Inc. unit market Avastin.
1/19/18 - Lupin launches generic Vibra-Tabs tablet in US [India Infoline News Service]
Pharma Major Lupin announced the launch of its Doxycycline Hyclate Tablet USP, 100 mg having received an approval from the United States Food and Drug Administration earlier. The stock is currently trading at Rs919, up by Rs0.6 or 0.07% from its previous closing of Rs918.4 on the BSE. The scrip opened at Rs920.25 and has touched a high and low of R
1/19/18 - Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application; Guidance for Industry; Availability
This final guidance describes the conditions under which FDA does not intend to take action against a State-licensed pharmacy, a Federal facility, or an outsourcing facility that mixes, dilutes, or repackages certain biological products outside the scope of an approved biologics license application. It also describes the conditions under which FDA
1/19/18 - New Drug Delivery Systems Study Results Reported from Huazhong University of Science and Technology (Recent Advances in the Application of Vitamin E...
New Drug Delivery Systems Study Results Reported from Huazhong University of Science and Technology. According to news reporting from Wuhan, People's Republic of China, by NewsRx journalists, research stated, "D-?-tocopheryl polyethylene glycol succinate has been approved by FDA as a safe adjuvant and widely used in drug delivery systems.
1/19/18 - Unknown BTCY May Have Big Upside Ahead of Likely Near-Term FDA Approval
-Biotricity just received FDA clearance for a new cardiomonitoring device and will be launching the product this year into a multi-billion dollar market with just a few competitors. Despite the allure of investing in the next big drug-and seeing 500% stock returns like Sangamo Therapeutics in the last year-looking for alpha generation in other heal
1/18/18 - Bausch + Lomb Receives FDA Approval of Lumify - The Only Over-The-Counter (OTC) Eye Drop With Low-Dose Brimonidine for the Treatment of Ocular Redness
Bausch+ Lomb, a leading global eye health company, announced that the U.S. Food and Drug Administration has approved LUMIFY (TM) as the first and only over-the-counter eye drop developed with low-dose brimonidine tartrate for the treatment of ocular redness. "We are proud to offer this unique new OTC eye drop to help our physicians and their patie
1/18/18 - Bausch + Lomb Receives FDA Approval of LUMIFY - The Only Over-The-Counter Eye Drop with Low-Dose Brimonidine for the Treatment of Ocular Redness
BRIDGEWATER, New Jersey- Bausch+ Lomb, a leading global eye health company, announced that the U.S. Food and Drug Administration has approved LUMIFY as the first and only over-the-counter eye drop developed with low-dose brimonidine tartrate for the treatment of ocular redness. 'We are proud to offer this unique new OTC eye drop to help our physici
1/18/18 - QIAGEN Receives FDA Approval to Expand Use of EGFR Test in Lung Cancer
GERMANTOWN, Maryland and HILDEN, Germany, January 18, 2018/ PRNewswire/. QIAGEN N.V. today announced that the U.S. Food and Drug Administration has approved a PMA supplement extending the indications for use of QIAGEN's therascreen EGFR RGQ PCR Kit as a companion diagnostic to guide the use of Boehringer Ingelheim's targeted therapy GILOTRIF
1/17/18 - Aeterna Zentaris Inc. Surges After Agreement With Strongbridge
Shares of Aeterna Zentaris Inc. were up 23.1% in late morning trading on January 17. The company announced that it had received United States Food and Drug Administration approval of Macrilen on December 20. The company will receive a cash payment of $24 million from Strongbridge and will be entitled to 15% royalty on net sales up to $75 million an
1/17/18 - Fasenra Approved in EU for Treatment of Severe Eosinophilic Asthma [T-break Tech (Middle East)]
The European Commission has approved Fasenra as an add-on maintenance treatment in patients with severe eosinophilic asthma. The approval, announced by therapy developer AstraZeneca and its global research and development arm, MedImmune, follows FDA approval of Fasenra in the U.S. in November 2017. Todays decision from the EC follows the recent app
1/17/18 - FDA Approves Addition Of Overall Survival Data To KYPROLIS (carfilzomib) Label
Amgen today announced that the U.S. Food and Drug Administration has approved the supplemental New Drug Application to add overall survival data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for KYPROLIS . "Overall survival is generally considered to be the gold standard of endpoints because it clearly demonstrate
1/17/18 - FDA approves new indication for Gilotrif in EGFR mutation-positive NSCLC
The FDA has approved a supplemental New Drug Application for Gilotrif for the first-line treatment of patients with metastatic non-small cell lung cancer...
1/17/18 - FDA approves Teva leukemia treatment [Syrian Arab News Agency]
Three months ago, Teva announced that the drug would be granted priority by the FDA, and predicted that a decision would be made in the first quarter of 2018. The FDA grants priority in considering requests for biological drugs or products designed to treat acute situations or unsatisfied medical needs. This label expansion represents an important
1/17/18 - FDA grants approval for first drug to treat inherited breast cancer [Sport360]
Patients are selected for treatment with Lynparza based on an FDA- approved genetic test, called the BRACAnalysis CDx. "This class of drugs has been used to treat advanced, BRCA-mutated ovarian cancer and has now shown efficacy in treating certain types of BRCA-mutated breast cancer," said Richard Pazdur, M.D., director of the FDA`s Oncology Cente
1/17/18 - International Biophysics obtains FDA 510k clearance for the FloPump 32 centrifugal heart pump
International Biophysics Corporation, a global medical device manufacturer based in Austin, Texas, announced they have received FDA 510 k clearance for their FloPump 32 centrifugal disposable heart pump. International Biophysics founder and CEO, H. David Shockley said, "With this FDA clearance of our FloPump 32 for the U.S. market we continue to
1/17/18 - Medtronic Receives FDA Clearance for Riptide Aspiration System
DUBLIN- Medtronic plc today announced that the company's Neurovascular business unit received U.S. Food and Drug Administration clearance of the Riptide Aspiration System, adding a valuable tool to the Acute Ischemic Stroke product portfolio. Daniel Sahlein, interventional neuroradiologist, Goodman Campbell Brain and Spine, assistant professor of..
1/17/18 - Medtronic Receives FDA Clearance for Riptide(TM) Aspiration System
Medtronic issued the following news release:. Medtronic plc today announced that the company's Neurovascular business unit received U.S. Food and Drug Administration clearance of the Riptide (TM) Aspiration System, adding a valuable tool to the Acute Ischemic Stroke product portfolio. "The Riptide Aspiration System will provide me with another pro
1/17/18 - U.S. FDA Approves Tevas Trisenox [Tehran Times (Iran)]
Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration has approved the use of TRISENOX injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia whose APL is characterized by the presence of the t translocation or PML/RAR-alpha gene expression.
1/16/18 - 3Sbio Inc: China FDA Approves New Once-Weekly Bydureon to Improve Glycemic Control in Patients with Type-2 Diabetes
As the first and currently the only GLP-1 medicine in China to be administered once-weekly, exenatide microsphere can reduce the frequency of dosing, reduce gastrointestinal adverse effects and increase drug stability and improve patient compliance by continuing to provide steady-state levels of exenatide with sustained release microsphere...
1/16/18 - Centric Medical? Announces FDA 510(k) Clearance of the Cannulated Screw Internal Fixation System for Foot and Ankle Indications
Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today announced today that the U.S. Food and Drug Administration has given 510 marketing clearance to the Cannulated Screw Internal Fixation System. This addition has allowed for a more robust off
1/16/18 - China FDA Approves New Once-Weekly Bydureon to Improve Glycemic Control in Patients with Type-2 Diabetes
By a News Reporter-Staff News Editor at China Weekly News 3 Sbio Inc. announced that China's first Glucagon-like peptide-1 receptor agonist weekly preparation Bydureon has been formally approved by China Food and Drug Administration, as a new treatment option to improve glycemic control for patients with type 2 diabetes. As the first and curre
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