Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers November 24, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - November 24, 2017

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 250     Next >>     Go To Page:

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 - 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 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 - GENERIC DRUG APPROVALS ON THE RISE IN US
The US Food and Drug Administration has approved 763 generic drug applications during Jan- Oct 2017 compared to 651 in 2016. Indian firms received approvals for 203 applications during Apr- Oct 2017, including tentative approvals. The US FDA also approved 101 drug applications in Oct 2017 alone, including 14 tentative approvals.
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...
11/16/17 - FDA approves Fasenra for severe eosinophilic asthma
The FDA has approved Fasenra for the add-on maintenance treatment of patients with severe asthma aged 12 years and older...(Visited 91 times, 91 visits today)
11/16/17 - FDA Approves Genentech's Gazyva for Previously Untreated Advanced Follicular Lymphoma
Genentech, a member of the Roche Group, announced today that the U.S. 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. Gazyva s supplemental Biologics License Application based on the GALLIUM data w
11/16/17 - 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 - FDA Clears Fairhaven Health's BabyDance? Fertility Lubricant for use When Trying to Get Pregnant
The U.S. Food and Drug Administration granted premarket approval to Fairhaven Health/ Isolove for its BabyDance? Fertilty Lubricant. BabyDance? is cleared by the FDA in the unique category for personal lubricants that are "gamete, fertilization and embryo compatible" for use by couples who are TTC and by health care providers during fertility i
11/16/17 - FDA OKs new therapy for some hemophilia patients
U.S. regulators have approved the first new treatment in nearly two decades to prevent internal bleeding in certain patients with hemophilia, an inherited blood-clotting disorder. The Food and Drug Administration on Thursday approved Hemlibra for hemophilia A patients. Genentech says the list price will be about $482,000 for the first year and sli
11/16/17 - Insulia receives FDA clearance and CE mark to integrate Basaglar and Tresiba
Today, Voluntis announced that Insulia , its digital companion for people with Type 2 diabetes, has received FDA clearance and the CE mark to integrate Basaglar and Tresiba. "It's complicated enough worrying about how to titrate your insulin, without having to worry about whether your brand of insulin is compatible with automatic titration too
11/16/17 - Kamada Reports Financial Results for Third Quarter and First Nine Months of 2017
'We were also pleased to have received the U.S. Food and Drug Administration approval in the third quarter for our Anti-Rabies IgG, KEDRAB, and look forward to launching this product in the U.S. in collaboration with Kedrion, our strategic partner, early in 2018. With the continued growth of sales of Glassia in the U.S. and our planned launch of Ke
Articles(s): 1 - 25 of 250     Next >>     Go To Page:


© 2017 Thomson Reuters. All rights reserved.

Pharmacy News Index
  Drug Delivery Systems
  Drugstores
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry

FEATURED CE LESSON

Legal & Practical Issues in Compounding Pharmacy
This lesson is supported by:
RxSchool
Men's Health in Older Adults: Benign Prostatic Hyperplasia and Erectile Dysfunction
This lesson is supported by:
RxSchool
Pharmacy Spanish
This lesson is supported by:
RxSchool

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...


Websites » RxCareerCenter.comRxSchool.comClubStaffing.comNursingJobSource.comRN.com
Copyright © 2017 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement
888-682-4415