Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers May 26, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - May 26, 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 44     Next >>     Go To Page:

5/26/17 - Data from M.R. Geier et al Provide New Insights into Vaccines [Quadrivalent human papillomavirus vaccine and autoimmune adverse events: a...
Data from M.R. Geier et al Provide New Insights into Vaccines. According to news originating from Silver Spring, Maryland, by NewsRx correspondents, research stated, "Gardasil is a quadrivalent human papillomavirus vaccine that was approved for use by the US Food and Drug Administration in June 2006. HPV4 vaccine is routinely recommended for admini
5/26/17 - FDA approves Sun Pharmas tildrakizumab for moderate-to-severe plaque psoriasis [Sudan Tribune]
Indian company Sun Pharmaceutical Industries has received the US Food and Drug Administration approval of the Biologics License Application for tildrakizumab to treat patients with moderate-to-severe plaque psoriasis. The FDA filing acceptance follows acceptance of the regulatory filing of tildrakizumab by the European Medicines Agency in March...
5/26/17 - GNW-News: Novartis receives FDA approval for expanded use of Zykadia in first-line ALK-positive metastatic non-small cell lung cancer (NSCLC) (english)
Novartis receives FDA approval for expanded use of Zykadia in first-line ALK-positive metastatic non-small cell lung cancer. Novartis International AG/ Novartis receives FDA approval for expanded use of Zykadia in first-line ALK-positive metastatic non-small cell lung cancer. Basel, May 26, 2017- Novartis today announced the US Food and Drug.
5/26/17 - Novartis receives FDA approval for expanded use of Zykadia in first-line ALK-positive metastatic non-small cell lung cancer (NSCLC)
Novartis today announced the US Food and Drug Administration approved the expanded use of Zykadia to include the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase- positive, as detected by an FDA- approved test. In January 2017, the FDA granted Zykadia Breakthrough Therapy..
5/25/17 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The following is a list of FDA information collections recently approved by OMB under section 3507
5/25/17 - Blog Coverage Merck's KEYTRUDA Becomes First Cancer Drug to be Approved by FDA Based on a Common Biomarker Instead of the Location of the Tumor
Upcoming AWS Coverage on Retrophin Post-Earnings Results. LONDON, UK/ ACCESSWIRE/ May 25, 2017/ Active Wall St. blog coverage looks at the headline from Merck& Co., Inc. as the Company announced that the US Food and Drug Administration has granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature.
5/25/17 - Don't let fake health news impact your family
It appears parents in Vermont are listening. In the current school year, 94 percent of Vermont's children in grades K-12 have received all required vaccines. Prior to approval by the Food and Drug Administration, manufacturers must demonstrate vaccine safety.
5/25/17 - FDA Approves Actemra for Giant Cell Arteritis [Syrian Arab News Agency]
Genentechs tocilizumab subcutaneous injection was approved by the U.S. Food and Drug Administration on Monday for the treatment of Giant Cell Arteritis. This is the sixth FDA approval for Actemra since it was launched in 2010 and the first drug approved to specifically treat patients with GCA. GCA is a chronic and severe autoimmune condition that i
5/25/17 - FDA approves first treatment for giant cell arteritis [T-break Tech (Middle East)]
It is the first drug of its kind to be made available by the Food and Drug Administration to treat adults with this condition, although it is already available in the United States in the same form for patients with severely active rheumatoid arthritis. Announcing the decision, Badrul Chowdhury, director of the division of pulmonary, allergy, and r
5/25/17 - FDA approves Mercks bladder cancer drug [Sport360]
In the first-line setting, Keytruda is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumour response rate and duration of response. Continued approval for this indication may
5/25/17 - FDA approves Sanofi and Regenerons Kevzara for adult rheumatoid arthritis [Syrian Arab News Agency]
Sanofi and Regeneron Pharmaceuticals drug Kevzara has received the US Food and Drug Administration approval to treat adult patients affected with moderately to severely active rheumatoid arthritis. Sanofi CEO Olivier Brandicourt said: Despite the many advances made in the treatment of rheumatoid arthritis, patients continue to need new treatment...
5/25/17 - FDA Clears Sciex`s Mass Spec-Based Vitamin D Test [Sport360]
The test, which will be offered through the company`s Sciex Diagnostics division, is the only FDA- cleared LC-MS-based Vitamin D assay kit currently on the market, Sciex said. According to Sciex, the Office of Inspector General "recently reported Vitamin D as one of the top five laboratory assays reimbursed by Medicare, accounting for 8.7 million l
5/25/17 - Novartis receives FDA approval for first-of-its-kind Kisqali Femara Co-Pack for initial treatment of HR+/HER2- advanced or metastatic breast cancer
By a News Reporter-Staff News Editor at Women's Health Weekly Novartis announced that the US Food and Drug Administration has approved the Kisqali Femara Co-Pack for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in postmenopausal women1. With this FDA appro
5/25/17 - NucleusHealth Receives FDA 510(k) Clearance for Nucleus.io [Sudan Tribune]
-NucleusHealth, advancing clinical practice and patient care through innovative medical image management and interpretation, has received U.S. Food and Drug Administration 510 clearance for its Nucleus.io technology. Nucleus.io is a web-based, scalable and secure cloud platform for medical image management. Were excited to bring our latest advance
5/25/17 - Orchid Pharma gets US FDA approval for Aripiprazole tablet [Sudan Tribune]
Orchid Pharma Limited, in its BSE filing on Wednesday, announced that it has received Abbreviated New Drug Application approval from US FDA for Aripiprazole Tablets USP, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg. Orchid Pharma Limited was trading at Rs 30.25, up by Rs 0.60 or 2.02%, on Wednesday, on the BSE. Orchid Pharma Ltd is currently trading
5/25/17 - US approves Keytruda for MSI-H tumours [T-break Tech (Middle East)]
The US Food and Drug Administration has cleared use of Merck& Cos immunotherapy Keytruda to treat cancer patients identified as having a biomarker called microsatellite instability-high or mismatch repair deficient. Microsatellite instability- or MSI- is caused by a deficiency in the cell`s ability to repair errors in the DNA sequence that occur du
5/24/17 - FDA approves first cancer treatment for any solid tumor with a specific biomarker
The US Food and Drug Administration granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker)...
5/24/17 - FDA Approves First Cancer Treatment for Any Solid Tumor with a Specific Genetic Feature
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. "This is an important first for the cancer community," said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research and director of the FDA's Oncolog
5/24/17 - FDA approves Merck's bladder cancer drug
The FDA has approved two new indications for Merck's Keytruda (pembrolizumab), the company's anti-PD-1 therapy, for bladder cancer...
5/24/17 - FDA approves Roche's Actemra/RoActemra (tocilizumab) for giant cell arteritis
-Actemra/RoActemra is the first FDA- approved treatment for adults with giant cell arteritis. -FDA previously granted Priority Review and Breakthrough Therapy Designation for Actemra/RoActemra in GCA. "Today's FDA decision means people living with giant cell arteritis will, for the first time, have an FDA- approved treatment option for this debili
5/24/17 - Merck Says FDA Approves New Indication For KEYTRUDA
WHITEHOUSE STATION- Merck said that the U.S. Food and Drug Administration has approved a new indication for KEYTRUDA, the company's anti-PD-1 therapy. KEYTRUDA is now indicated for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high or mismatch repair deficient. solid tumors that have...
5/24/17 - NucleusHealth? Receives FDA 510(k) Clearance for Nucleus.io?
NucleusHealth?, advancing clinical practice and patient care through innovative medical image management and interpretation, has received U.S. Food and Drug Administration 510 clearance for its Nucleus.io technology. Nucleus.io is a web-based, scalable and secure cloud platform for medical image management. "We're excited to bring our latest adv
5/24/17 - Orchid Pharma gets US FDA approval for Aripiprazole tablet [India Infoline News Service]
Orchid Pharma Limited, in its BSE filing on Wednesday, announced that it has received Abbreviated New Drug Application approval from US FDA for Aripiprazole Tablets USP, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg. Orchid Pharma Limited, in its BSE filing on Wednesday, announced that it has received Abbreviated New Drug Application approval from US
5/24/17 - Roche receives FDA approval for complementary PD-L1 (SP263) biomarker test [Sport360]
Roche announced approval of the VENTANA PD-L1 Assay by the US Food and Drug Administration as a complementary diagnostic3 to provide PD-L1 status for patients with locally advanced or metastatic urothelial carcinoma 4 who are being considered for treatment with the FDA- approved anti-PD-L1 immunotherapy IMFINZI. "We are very pleased the VENTANA PD
5/24/17 - SCIEX Announces the First FDA-Cleared Vitamin D Assay Kit for Mass Spectrometry
SCIEX Diagnostics, the in vitro diagnostics division of SCIEX, a global leader in mass spectrometry in the life sciences industry, announced today the first and only FDA- cleared LC-MS based Vitamin D assay kit, the Vitamin D 200 M Assay, exclusively for the SCIEX Topaz? System. The Topaz System is a fully integrated LC-MS platform driven by Clea
Articles(s): 1 - 25 of 44     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
Telepharmacy- Remote Delivery of Pharmacy Services
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
Drug Therapy Management Series Part III: Geriatric Disorders
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