Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers February 22, 2018
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - February 22, 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 65     Next >>     Go To Page:

2/21/18 - AstraZeneca - US FDA approves Imfinzi for unresectable Stage III non-small cell lung cancer
AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration has approved Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
2/21/18 - FDA Approves Osmotica Pharmaceutical's Once-Daily OSMOLEX ER extended-release tablets
Bridgewater- Osmotica Pharmaceutical US LLC, a privately-held specialty pharmaceutical company developing novel central nervous system treatments utilizing its proprietary osmotic drug delivery platform, announced today that the U.S. Food and Drug Administration has approved OSMOLEX ER, an amantadine extended release tablet, for the treatment of...
2/21/18 - FDA Clears Oricula Therapeutics Investigational New Drug Application for Clinical Trials
By a News Reporter-Staff News Editor at Biotech Week ORICULA THERAPEUTICS, LLC., a biotech company introducing medications to preserve hearing and balance, announced FDA permission to begin volunteer human testing for safety, tolerability, and pharmacokinetics of their novel, new medicine, ORC-13661. Oricula Therapeutics CEO Malcolm Gleser, MD, P
2/21/18 - Mylan Receives Tentative Approval for Combination HIV Treatment DTG FTC TAF under FDA's PEPFAR Program
HERTFORDSHIRE, England and PITTSBURGH- Global pharmaceutical company Mylan N.V. today announced receipt of tentative approval from the U.S. Food and Drug Administration under the U.S. President's Emergency Plan for AIDS Relief for its New Drug Application for Dolutegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg.
2/21/18 - Nebraska Medicine gets FDA approval for new cancer treatment [Sport360]
After an endorsement last summer, the Food and Drug Administration has now approved a new type of cancer treatment. Now, Nebraska Medicine`s Fred& Pamela Buffet Cancer Center can take the new therapy out of clinical trials and offer it to more patients. "It means that I`m alive today," said Amy Cheese, a patient.
2/21/18 - SANUWAVE Health, Inc.,CEO Kevin Richardson Returns to Uptick Newswire's Stock Day with Everett Jolly to Discuss Recent Accomplishments
SANUWAVE Health, Inc., today announced CEO Kevin Richardson s interview on Uptick Newswire s Stock Day podcast with Everett Jolly. SANUWAVE Health recently received FDA approval for dermaPACE, a state of the art device that treats diabetic foot ulcers and is compatible with a host of other products. About SANUWAVE Health, Inc. SANUWAV
2/21/18 - ZYTIGA abiraterone acetate Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer
By a News Reporter-Staff News Editor at Biotech Week The Janssen Pharmaceutical Companies of Johnson& Johnson announced that the U.S. Food and Drug Administration has approved a new indication for ZYTIGA in combination with prednisone for the treatment of patients with metastatic high-risk castration-sensitive prostate cancer.
2/20/18 - AstraZeneca - US FDA approves Imfinzi for unresectable Stage III non-small cell lung cancer
AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration has approved Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
2/20/18 - FDA Clears GOKnee3D MRI Application From Siemens Healthineers
Siemens Healthineers issued the following news release:. The U.S. Food and Drug Administration has cleared GOKnee3D, a magnetic resonance imaging application from Siemens Healthineers that significantly reduces the time required to perform comprehensive diagnostic exams of the knee. "The commercial availability of the GOKnee3D MRI application enab
2/20/18 - Mylan Receives Tentative Approval for Combination HIV Treatment DTG/FTC/TAF Under FDA's PEPFAR Program
HERTFORDSHIRE, England and PITTSBURGH, Feb. 20, 2018/ PRNewswire/ Global pharmaceutical company Mylan N.V. today announced receipt of tentative approval from the U.S. Food and Drug Administration under the U.S. President's Emergency Plan for AIDS Relief for its New Drug Application for Dolutegravir, Emtricitabine, and Tenofovir Alafenamide Tablet
2/20/18 - NeoTract Announces FDA Clearance of Expanded Indications for UroLift System
NeoTract, a wholly owned subsidiary of Teleflex Incorporated focused on addressing unmet needs in the field of urology, today announced that the U.S. Food and Drug Administration has cleared new indications for the UroLift System for the treatment of enlarged prostate, or benign prostatic hyperplasia. These expanded indications mean that patient
2/19/18 - Abiomed Announces Peripartum and Postpartum Cardiomyopathy Approval and Women's Initiative for Heart Recovery
DANVERS- Abiomed, Inc., a leading provider of breakthrough heart support and recovery technologies, announced today the launch of a new indication and Women's Initiative focused on heart recovery education and awareness. This Women's Initiative is in conjunction with the Company's expanded FDA approval for cardiogenic shock associated with...
2/19/18 - Abiomed Receives Approval for Expanded FDA Indication for Cardiomyopathy with Cardiogenic Shock
DANVERS- Abiomed, Inc., a leading provider of breakthrough heart support and recovery technologies, announced today that it has received an expanded U.S. Food and Drug Administration Pre-Market Approval for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps to provide treatment for heart failure associated with cardiomyopathy leadi
2/19/18 - Abiomed Receives Approval for Expanded FDA Indication for High Risk Percutaneous Coronary Intervention Procedures
DANVERS- Abiomed, Inc., a leading provider of breakthrough heart support and recovery technologies, today announced that it has received an expanded U.S. Food and Drug Administration Pre-Market Approval for the Impella 2.5 and Impella CP heart pumps during elective and urgent high risk percutaneous coronary intervention procedures.
2/19/18 - Antares Pharma Announces FDA Approval Of Partner's Product Utilizing Our Quickshot Auto Injector
EWING- Antares Pharma, Inc. today announced the successful regulatory outcome of the Makena subcutaneous auto injector collaboration with AMAG Pharmaceuticals. This first pass approval was made possible through an excellent working collaboration with our device team and the development group at AMAG,' said Robert F. Apple, President and Chief Execu
2/19/18 - AstraZeneca's IMFINZI approved for Stage III nsclc
AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration has approved Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
2/19/18 - AstraZeneca: Imfinzi Receives FDA Approval To Treat Unresectable Stage III NSCLC
LONDON- AstraZeneca PLC and MedImmune announced the. US FDA has approved Imfinzi for the treatment of patients with unresectable Stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval is based on the positive PFS data from the Phase III PACIFIC trial
2/19/18 - Embrace by Empatica is the world's first smart watch to be cleared by FDA for use in Neurology
By a News Reporter-Staff News Editor at Clinical Trials Week Empatica Inc has received clearance from the FDA for Embrace, its award-winning smart watch. Embrace uses AI to monitor for the most dangerous kinds of seizures, known as "grand mal" or "generalized tonic-clonic" seizures, and send an alert to summon caregivers' help. In a multi-site cl
2/19/18 - FDA Approves Osmotica Pharmaceutical's Once-Daily OSMOLEX ER? (amantadine) extended-release tablets for the treatment of Parkinson's Disease and Drug-Induced Extrapyramidal Reactions in Adults
Osmotica Pharmaceutical US LLC, a privately-held specialty pharmaceutical company developing novel central nervous system treatments utilizing its proprietary osmotic drug delivery platform, announced today that the U.S. Food and Drug Administration has approved OSMOLEX ER?, an amantadine extended release tablet, for the treatment of Parkinson'
2/19/18 - Grifols HyperRAB rabies immune globulin [human] 300 IU/mL Receives FDA Approval to Treat Patients Exposed to Rabies Virus Infection
By a News Reporter-Staff News Editor at Pharma Business Week Grifols, a leading global producer of plasma-derived medicines and provider of a variety of postexposure prophylaxis and immune globulin products for patients, has received approval from the U.S. Food& Drug Administration for a new higher potency formulation of its HyperRAB rabies im
2/19/18 - Novartis receives FDA approval for Cosentyx label update to include moderate to severe scalp psoriasis
By a News Reporter-Staff News Editor at Pharma Business Week Novartis announced that the US Food and Drug Administration has approved a label update for Cosentyx , the first interleukin-17A antagonist approved to treat moderate to severe plaque psoriasis.1 The updated label includes Cosentyx data in moderate to severe scalp psoriasis- one of th
2/19/18 - Novo Nordisk Launches Ozempic and Fiasp, Expanding Treatment Options for Adults with Diabetes
By a News Reporter-Staff News Editor at Clinical Trials Week Novo Nordisk announced the availability of two new diabetes medications, Ozempic injection 0.5 mg or 1 mg and Fiasp 100 Units/mL at pharmacies across the United States. Both medications received approval from the U.S. Food and Drug Administration in 2017 and represent the latest a
2/19/18 - Parker - Indego Exoskeleton Receives U.S. Regulatory Clearance for Stroke Treatment
CLEVELAND- Parker Hannifin Corporation, the global leader in motion and control technologies, today announced that the U.S. Food and Drug Administration has given additional clearance to market and sell the Indego exoskeleton for use in the treatment of individuals with hemiplegia due to stroke. 'We are excited that Indego is now available for a mu
2/19/18 - Trethera Corporation Announces FDA Clearance of Investigational New Drug Application for TRE-515
By a News Reporter-Staff News Editor at Pharma Business Week Trethera Corporation, a biopharmaceutical company committed to developing novel drugs targeting cellular nucleotide metabolism for the treatment of cancer, announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for TRE-515, a novel,...
2/19/18 - U.S. FDA Approves NorthStar Medical Radioisotopes' RadioGenixTM System Technetium Tc 99m Generator for Non-uranium Sourced Molybdenum-99 Mo-99...
By a News Reporter-Staff News Editor at Pharma Business Week NorthStar Medical Radioisotopes, LLC, a company involved in the production and distribution of radioisotopes used for medical imaging, announced that the U.S. Food and Drug Administration has approved the RadioGenixTM System, an innovative, high tech radioisotope separation platform ind
Articles(s): 1 - 25 of 65     Next >>     Go To Page:


© 2018 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 © 2018 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement
888-682-4415