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 The leading web portal for pharmacy resources, news, education and careers November 21, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - November 21, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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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...
11/17/17 - Cincinnati Children's Research Paves Way for Newly Approved Asthma Drug
Thanks in part to nearly two decades of research at Cincinnati Children's Hospital Medical Center, the FDA has approved benralizumab, the first drug designed to specifically deplete eosinophils as a treatment for asthma. The FDA approved benralizumab as an add-on maintenance treatment for severe asthma with eosinophil involvement.
11/17/17 - Eagle Pharmaceuticals Receives Tentative FDA Approval for PEMFEXY Pemetrexed Injection Ready-to-Dilute
By a News Reporter-Staff News Editor at Drug Week Eagle Pharmaceuticals, Inc. announced that the United States Food and Drug Administration has granted tentative approval for the Company's PEMFEXY?, a pemetrexed injection ready-to-dilute formulation for locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with...
11/17/17 - EIZO RadiForce RX560 5 Megapixel Color Medical Monitor Receives FDA 510(k) Clearance for Breast Tomosynthesis and Digital Mammography
Hakusan, Japan- EIZO Corporation announced that it has received FDA 510 clearance for breast tomosynthesis and digital mammography from the U.S. Food and Drug Administration for its 5 megapixel color medical monitor, the RadiForce RX560. Breast cancer screenings increasingly combine the use of mammography and ultrasound to view patients with high b
11/17/17 - FASENRA receives US FDA approval for severe eosinophilic asthma
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration has approved FASENRA for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Pascal Soriot, Chief Executive Officer of AstraZeneca, said:' We'
11/17/17 - FDA approves drug to treat pediatric, adult patients with rare Sly syndrome [Syrian Arab News Agency]
The U.S. Food and Drug Administration today approved Mepsevii to treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII, also known as Sly syndrome. MPS VII is an extremely rare, progressive condition that affects most tissues and organs. "This approval underscores the agency`s commitment to
11/17/17 - FDA approves first digital pill [Arab Times (Kuwait)]
Announcing the decision, Mitchell Mathis, director of the Division of Psychiatry Products in the FDAs Center for Drug Evaluation and Research said: Being able to track ingestion of medications prescribed for mental illness may be useful for some patients. The decision was welcomed by John Kane, chair of psychiatry at the Donald and Barbara Zucker S
11/17/17 - FDA approves first telehealth option to program cochlear implants remotely
SILVER SPRING, Md., Nov. 17, 2017/ PRNewswire-USNewswire/ The U.S. Food and Drug Administration today approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform. Being able to have a qualified audiologist program the device via telemedicine from a remote location can greatl
11/17/17 - FDA Approves First Test for Screening Zika Virus in Blood Donations
FDA has approved the Cobas Zika test intended to detect the Zika virus in blood donations.
11/17/17 - FDA approves mental health pill with sensor to track use compliance [Naples Daily News, Fla.]
An ingestible sensor is embedded in the medication, Abilify, for treating schizophrenia, manic episodes with bi-polar disorder, and depression, according to the FDA. The sensor component is the size of a grain of sand, and is made up of ingredients found in food, according to Otsuka Pharmaceutical Co., based in Tokyo and Redwood City, California.
11/17/17 - FDA Approves Remote Programming Feature for the Nucleus Cochlear Implant System
The remote programming feature is indicated for patients who have had six months of experience with their cochlear implant sound processor and are comfortable with the programming process.
11/17/17 - FDA approves Roche's Gazyva for previously untreated advanced follicular lymphoma
Basel Roche announced today that the US Food and Drug Administration approved Gazyva 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 the thousands of people diagnosed each year with follicu
11/17/17 - FDA Approves Roche's Hemlibra (Emicizumab-kxwh) for Haemophilia A With Inhibitors
Roche, a biotech company, issued the following news release:. Roche today announced that the US Food and Drug Administration has approved Hemlibra (R) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors. "People with haemophilia A who develop inhibito
11/17/17 - FDA OKs new therapy for some hemophilia patients
The list price will be about $482,000 for the first year and slightly less after that, said California- based Genentech, which developed the drug. Genentech, the biotech subsidiary of Swiss drugmaker Roche, says that's half the cost of the only other preventive option for patients with this problem. The FDA gave expedited approval to Hemlibra, also
11/17/17 - Sonoma Pharmaceuticals Announces FDA Approval of Expanded Indication for Alevicyn to Add Antimicrobial Language [Tehran Times (Iran)]
Sonoma Pharmaceuticals, Inc., a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care, today announced that the U.S. Food and Drug Administration has approved an expanded claim for the companys signature dermatology product, Alevicyn Dermal..
11/16/17 - ADDING MULTIMEDIA FDA Approves Genentech's HEMLIBRA (emicizumab-kxwh) for Hemophilia A with Inhibitors
Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration has approved HEMLIBRA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors. People with hemophilia A who develop inhibitors face significant challeng
11/16/17 - Ask the Doctors: Newly approved gene therapy a breakthrough in cancer treatment
Dear Doctor: Our daughter was successfully treated for leukemia as a child, but the chemotherapy she went through was brutal. Now, I've read that we have the first gene therapy for cancer, which is a huge deal. Kymriah is the first gene therapy to be approved by the Food and Drug Administration.
11/16/17 - Chugai's HEMLIBRA Receives the World's First Regulatory Approval from FDA for Hemophilia A with Inhibitors
Chugai Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration has approved the bispecific antibody emicizumab for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A with factor VIII inhibitors. We are pleased that HEMLIBRA, a biopharmaceutical
11/16/17 - Cincinnati Children's Research Paves Way for Newly Approved Asthma Drug
Thanks in part to nearly two decades of research at Cincinnati Children's Hospital Medical Center, the FDA has approved benralizumab, the first drug designed to specifically deplete eosinophils as a treatment for asthma. The FDA approved benralizumab as an add-on maintenance treatment for severe asthma with eosinophil involvement.
11/16/17 - EU, US approvals for Faslodex combinations [Algeria Press Service]
AstraZenecas Faslodex has been cleared on both sides of the Atlantic for use in combination with a CDK4/6 inhibitor. Both the European Commission and US Food and Drug Administration have approved the combination for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2 negative locally advanced or metastatic breast...
11/16/17 - Fasenra (benralizumab) receives US FDA approval for severe eosinophilic asthma [Sport360]
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration has approved Fasenra for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Pascal Soriot, Chief Executive Officer of AstraZeneca, said: Were
11/16/17 - FDA Approves a Trackable `Digital Pill` That Delivers Schizophrenia Medication [All Iraq News Agency (AIN)]
The FDA has announced its first ever approval of a pill with an embedded sensor that digitally tracks if patients have ingested it, ushering the US into a new era of smart pharmaceuticals and medical surveillance. "Being able to track ingestion of medications prescribed for mental illness may be useful for some patients," says the FDA`s director o
11/16/17 - FDA Approves Benralizumab for Severe Asthma [All Iraq News Agency (AIN)]
The FDA has approved AstraZeneca`s biologic drug benralizumab for the add-on maintenance treatment of patients age 12 years and over with severe asthma with an eosinophilic phenotype, the drugmaker announced late Tuesday. The two other IL-5 biologics approved by the FDA for severe, uncontrolled asthma GlaxoSmithKline`s mepolizumab and Teva`s...
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