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 The leading web portal for pharmacy resources, news, education and careers November 20, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - November 20, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 97     Next >>     Go To Page:

11/20/17 - Batu Biologics Receives FDA Clearance for First Multi-Pronged Immunotherapy Targeting the Blood Vessels that Feed Cancer
By a News Reporter-Staff News Editor at Cancer Vaccine Week Batu Biologics, an immuno-oncology company dedicated to the development of its tumor-angiogenesis targeting immune therapy, ValloVax?, has received an Investigational New Drug approval from the U.S. Food and Drug Administration allowing Batu to proceed with Phase 1 clinical trials.
11/20/17 - Biocon rallies 4% after Bengaluru unit gets cleared by US FDA [India Infoline News Service]
The US FDA had audited the company s aseptic drug facility between May 25 and June 3 The US Food and Drug Administration issued an Establishment Inspection Report in relation to the inspection of Biocon s Bengaluru unit. The US FDA had previously issued a report in which they issued 10 observations on Biocon s Bengaluru plant. Biocon Ltd i
11/20/17 - Chugai's ALK Inhibitor "Alecensa" Approved for the Treatment of First Line Therapy on ALK-Positive Non-Small Cell Lung Cancer in the US
By a News Reporter-Staff News Editor at Pharma Business Week Chugai Pharmaceutical Co., Ltd. announced that Genentech Inc., a member of the Roche Group, obtained approval from the U.S. Food and Drug Administration, for Alecensa in the treatment of "anaplastic lymphoma kinase- positive metastatic non-small cell lung cancer". "In July 2014, Ale
11/20/17 - Cipla receives final approval for Generic Dacogen [India Infoline News Service]
Generic Dacogen vial is indicated for treatment of patients with myelodysplastic syndromes Cipla has announced that it has received final approval for its Abbreviated New Drug Application for Decitabine Injection 50 mg single-use sterile vial from the United States Food and Drug Administration to market a generic version of Otsuka America...
11/20/17 - Divi's Lab seen up as USFDA clears Vizag Unit-II [India Infoline News Service]
Shares of Divi's Laboratories is likely to gain in today's trade following the approval from the USFDA for its Vizag unit. Divi's Laboratories is likely to witness positive traction in the stock as the US Food and Drug Administration has cleared the company's unit-II in Vishakhapatnam, Andhra Pradesh. In the last trading session, Divis Laboratories
11/20/17 - Emergent BioSolutions Receives FDA Approval to Manufacture ACAM2000 at Canton, Massachusetts Facility
Emergent BioSolutions Inc. today announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application for the manufacture of ACAM2000 , in the company s newly-acquired cGMP live viral manufacturing facility in Canton, Massachusetts. Finalizing and receiving FDA licensure for the tech transfer of
11/20/17 - FDA approves Hemlibra to prevent bleeding in patients with haemophilia A
The FDA has approved Hemlibra to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with haemophilia A...(Visited 31 times, 31 visits today)
11/20/17 - Federal Register Extracts
SUMMARY: The Food and Drug Administration is announcing that it has received a petition requesting exemption from the premarket notification requirements for over-the-counter denture repair kits. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997.
11/20/17 - Medical Devices; Exemption From Premarket Notification: Over-the-Counter Denture Repair Kits
SUMMARY: The Food and Drug Administration is announcing that it has received a petition requesting exemption from the premarket notification requirements for over-the-counter denture repair kits. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997.
11/20/17 - Medtronic Announces FDA Approval and U.S. Launch of Next Generation Pacemakers
Azure (TM) with BlueSync (TM) Technology Improves Device Longevity and Provides Automatic, Wireless Remote Patient Monitoring DUBLIN- November 20, 2017- Medtronic plc today announced U.S. Food and Drug Administration approval and U.S. commercial launch for its portfolio of Azure (TM) pacemakers with BlueSync (TM) technology. Azure pacemakers featur
11/20/17 - Reports Outline Pharmaceutical Research Study Results from University of Eastern Finland (Prodrugs - Recent approvals and a glimpse of the pipeline)
By a News Reporter-Staff News Editor at Clinical Trials Week Research findings on Drugs and Therapies- Pharmaceutical Research are discussed in a new report. In 2015 alone, the FDA approved seven prodrugs, which gives a prodrug prevalence of over 20% among the small molecules or over 15% among the total amount of the FDA approved drugs that year.
11/20/17 - Seattle Genetics Announces FDA Approval of ADCETRIS Brentuximab Vedotin for Primary Cutaneous Anaplastic Large Cell Lymphoma pcALCL and...
By a News Reporter-Staff News Editor at Clinical Trials Week Seattle Genetics, Inc. announced that the U.S. Food and Drug Administration has approved ADCETRIS for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma and CD30-expressing mycosis fungoides who have received prior systemic therapy. This is the fourth
11/20/17 - Stryker receives US FDA HDE approval for the Neuroform Atlas Stent System to treat wide neck aneurysms
By a News Reporter-Staff News Editor at Pharma Business Week Stryker Corporation announced that the U.S. Food and Drug Administration has approved the Neuroform Atlas? Stent System for marketing under a humanitarian device exemption. Zaidat, Director of the Neuroscience and Stroke Center at Mercy Hospital in Toledo, Ohio, and Co-Principal Inves
11/20/17 - Surrogate marker and design of Calliditas Therapeutics' IgA nephropathy Phase 3 study agreed with the FDA
The design for the Nefecon Phase 3 study was agreed at the latest meeting with the FDA in September 2017, building on the groundbreaking acceptance of proteinuria as a surrogate marker for accelerated approval, which the company received in an end of Phase 2 b meeting in January 2017. The company believes that this was the first time the FDA grante
11/20/17 - U.S. FDA Approves Kalo's AUVI-Q (Epinephrine Injection, USP) 0.1 mg Auto-Injector for Life-Threatening Allergic Reactions in Infants and Small Children
The sNDA for the AUVI-Q 0.1 mg Auto-injector was granted Priority Review by the FDA, an expedited regulatory pathway reserved for products that may provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to available therapies. The new 0.1 mg-dose epinephrine...
11/20/17 - Ultragenyx Announces FDA Approval of MEPSEVII the First Therapy for Progressive and Debilitating Rare Genetic Disease Mucopolysaccharidosis VII
NOVATO, Calif.- Ultragenyx Pharmaceutical Inc., a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced that the U.S. Food and Drug Administration has approved MEPSEVII, the first medicine approved for the treatment of children and adults with Mucopolysaccharidosis VII.
11/20/17 - Volpara Receives Regulatory Clearances in Japan and Taiwan
WELLINGTON, New Zealand, Nov. 20, 2017/ PRNewswire/ Volpara Solutions announced today that it has received regulatory clearances for its suite of quantitative breast imaging tools in Japan and Taiwan. In Taiwan, Volpara Density? and Volpara Dose? have received regulatory clearance as a Class II medical device from the Taiwan Food and Dr
11/18/17 - FDA approves new drug to treat bleeding in hemophilia A patients [Tehran Times (Iran)]
The U.S. Food and Drug Administration today approved Hemlibra to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII inhibitors. Today`s approval provides a new preventative treatment that has been shown to significantly reduce the number of bleeding
11/18/17 - FDA approves Roche potential haemophilia blockbuster [Tehran Times (Iran)]
The FDA has approved Roches highly-anticipated haemophilia drug, emicizumab, offering a more weekly dosing schedule and improved bleeding prevention than rivals from Bayer, Shire and Novo Nordisk. But this will come with the hefty price tag of $482,000 per year, falling to around $448,000 a year after that, making it one of the most expensive drugs
11/18/17 - FDA Approves Roche's Gazyva for Previously Untreated Advanced Follicular Lymphoma
Roche, a biotech company, issued the following news release:. Roche announced today that the US Food and Drug Administration approved Gazyva (R) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma. "Today's Gazyva approval is an important advance for t
11/18/17 - Proteus Digital Health CEO talks about significance of FDAs digital pill approval [Sport360]
For Andrew Thompson, cofounder and CEO of Proteus Digital Health, this week in which the U.S. Food and Drug Administration granted approval for the first ingestible sensor-embedded drug Abilify Mycite is a momentous time. It marks a significant advancement for people with serious mental health disorders to work with their physicians to better manag
11/18/17 - US FDA grants marketing approval to electric stimulation device, NSS-2 Bridge device to reduce symptoms of opioid withdrawal [Sudan Tribune]
The US Food and Drug Administration granted a new indication to an electric stimulation device for use in helping to reduce the symptoms of opioid withdrawal. While we continue to pursue better medicines for the treatment of opioid use disorder, we also need to look to devices that can assist in this therapy, said FDA Commissioner Scott Gottlieb, M
11/17/17 - Allergan Receives Approval for Ozurdex Dexamethasone Intravitreal Implant 0.7 mg in China for the Treatment of Retinal Vein Occlusion RVO
By a News Reporter-Staff News Editor at Health& Medicine Week Allergan plc announced that it has received an Imported Drugs License from the Chinese Food and Drug Administration to market Ozurdex for the treatment of adult patients with macular edema following either Branch Retinal Vein Occlusion or Central Retinal Vein Occlusion.
11/17/17 - AstraZeneca - FASLODEX receives US FDA approval for the treatment of advanced breast cancer in combination with abemaciclib
AstraZeneca today announced that the US Food and Drug Administration has approved a new indication for FASLODEX, expanding the indication to include use with abemaciclib, a CDK4/6 inhibitor, for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer in women with disease...
11/17/17 - AstraZeneca receives US FDA approval for Faslodex to treat advanced breast cancer in combo with abemaciclib [Arab Times (Kuwait)]
AstraZeneca has announced that the US Food and Drug Administration has approved a new indication for Faslodex, expanding the indication to include use with abemaciclib, a CDK4/6 inhibitor, for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer in women with disease...
Articles(s): 1 - 25 of 97     Next >>     Go To Page:


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