Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers December 12, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - December 12, 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 55     Next >>     Go To Page:

12/12/17 - Alembic Pharma gains 1% as associate company gets US FDA approval [Arab News (Saudi Arabia)]
Rhizen Pharmaceuticals SA, an associate company of Alembic Pharmaceuticals, today announced that the US FDA has granted Fast Track Designation for RP6530, the company`s highly selective and orally active dual PI3K delta/ gamma inhibitor, for the treatment of patients with relapsed/ refractory peripheral T-cell lymphoma. In the morning session, Alem
12/12/17 - Alembic Pharma gains on USFDA approval for Darifenacin [India Infoline News Service]
Alembic Pharmaceuticals Limited today announced that the company has received approval from the US Food and Drug Administration for its Abbreviated New Drug Application Darifenacin Extended- Release Tablets, 7.5 mg and 15 mg. Alembic Pharmaceuticals, a leading pharmaceutical company, is a market leader in the macrolides segment of anti-infective dr
12/12/17 - Allergan Receives FDA Clearance For the CoolSculpting Treatment To Improve Appearance Of Lax Tissue In The Double Chin
Allergan plc today announced that the CoolSculpting treatment is the first and only non-surgical fat reduction technology to be FDA- cleared for improved appearance of lax tissue in conjunction with submental fat, or double chin, treatments. "A 2017 American Society for Dermatologic Surgery survey revealed that 73 percent of patients are both
12/12/17 - EKF Procalcitonin Assay Scores FDA Clearance
The Stanbio Chemistry Procalcitonin LiquiColor assay from EKF Diagnostics has received FDA premarket notification (510(k)) clearance and is validated for use on Beckman AU 480, 680, and 5800 clinical chemistry analyzers from Beckman Coulter.
12/12/17 - FDA approves Admelog, the first follow-on insulin product to treat diabetes
The FDA has approved Admelog, a short-acting insulin indicated to improve control in blood sugar levels in diabetes...
12/12/17 - FDA approves first drug for Eosinophilic Granulomatosis with Polyangiitis, a rare disease formerly known as the Churg-Strauss Syndrome
This new indication provides the first FDA- approved therapy specifically to treat EGPA. "Prior to today's action, patients with this challenging, rare disease did not have an FDA- approved treatment option," said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug E
12/12/17 - FDA Approves Investigational Device Exemption for SetPoint Bioelectronic Therapy Clinical Study in Rheumatoid Arthritis [Tehran Times (Iran)]
SetPoint Medical, a clinical-stage biomedical technology company developing an implantable bioelectronic medicine therapy for chronic inflammatory diseases, has received Investigational Device Exemption approval from the U.S. Food& Drug Administration to initiate a pilot trial in the U.S. for patients with drug refractory rheumatoid arthritis.
12/12/17 - FDA Approves Sanofi's Admelog (Insulin Lispro Injection)
Sanofi, a life sciences company, issued the following news release:. The U.S. Food and Drug Administration has approved Sanofi's Admelog (R), the first follow-on insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. Complementing our existing insulin portfolio, Admelog will offer a more affordable option for thos
12/12/17 - Global Melanoma Drugs Market to Receive Overwhelming Hike in Revenues by 2016 2023: The melanoma drugs market has been segmented based on type of drug therapy into chemotherapy, immunotherapy and, targeted therapy.
Albany, NY 12/11/2017 According to the American Academy of Dermatology, the prevalence of melanoma is gradually increasing and rapidly spreads to other parts of the body. However, if melanoma is detected at an early stage i.e. in situ or stage 0. Since, 2011 various drugs have received FDA approval for treatment of melanoma.
12/12/17 - GSK achieves approval for Nucala (mepolizumab) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) for adults in the US
GlaxoSmithKline plc today announced that the US Food and Drug Administration has approved Nucala as the first targeted treatment for eosinophilic granulomatosis with polyangiitis, previously known as Churg-Strauss syndrome. Eric Dube, Senior Vice President& Head, GSK Global Respiratory Franchise, said: "Following physician and patient experience
12/12/17 - Impax Receives Tentative FDA Approval of Generic Coreg CR Extended-Release Capsules
BRIDGEWATER, N.J.- Impax Laboratories, Inc., a specialty pharmaceutical company, today announced it has received tentative U.S. Food and Drug Administration approval on its Abbreviated New Drug Application for a generic version of Coreg CR extended-release capsules, 10, 20, 40 and 80 mg. Impax Laboratories, Inc. is a specialty pharmaceutical compan
12/12/17 - Omeros Corporation Announces FDA Approval of OMIDRIA for Use in Pediatric Patients
Omeros Corporation, a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system, today announced that the U.S. Food and...
12/12/17 - Sanofi Announces FDA Approval Of Admelog
PARIS- Sanofi reported that the U.S. FDA has approved Admelog, the first follow-on insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. Admelog is a rapid-acting insulin similar to Humalog, another insulin lispro 100 Units/mL, currently approved in the U.S. Admelog will be available in both vials and the SoloSta
12/12/17 - Spinal Cord Stimulator Market to Witness an Outstanding Growth by 2025: Spinal cord stimulator (SCS) is also known as dorsal column stimulator. The system comprises and an electric pulse generator. Functioning of the spinal cord stimulator is based o
Spinal cord stimulation received approval from the U.S. FDA in 1989 for indications such as nerve damage in the trunk, arms, or legs. According to a study conducted by the Institute of Medicine of The National Academies, 100 million people in the U.S. suffer from chronic pain. In May 2015, Nevro Corporation received the U.S..
12/12/17 - SSY Group's injection approved for production & registration [ET Net News (China)]
SSY Group said the Group has obtained. from the China Food and Drug Administration. According to the new regulation issued by the China Food and Drug Administration on 30.
12/11/17 - Alembic Pharma gains 1% as associate company gets US FDA approval [India Infoline News Service]
Rhizen Pharmaceuticals SA, an associate company of Alembic Pharmaceuticals, today announced that the US FDA has granted Fast Track Designation for RP6530, the company's highly selective and orally active dual PI3K delta/ gamma inhibitor, for the treatment of patients with relapsed/ refractory peripheral T-cell lymphoma. In the morning session, Alem
12/11/17 - Boston Scientific Receives U.S. FDA Approval for the Vercise? Deep Brain Stimulation System
Boston Scientific Corporation today announced that it has received approval from the U.S. Food and Drug Administration for the Vercise? Deep Brain Stimulation System. The approval was based on the INTREPID study, the first multi-center, prospective, double-blind, randomized sham-controlled study of DBS for PD in the U.S. The INTREPID study eval
12/11/17 - FDA Approves Ferring's CLENPIQ sodium picosulfate, magnesium oxide, and anhydrous citric acid Oral Solution for Colonoscopy Prep
By a News Reporter-Staff News Editor at Pharma Business Week The U.S. Food and Drug Administration has granted Ferring Pharmaceuticals Inc. approval to market CLENPIQ? oral solution for cleansing of the colon in adults undergoing a colonoscopy. Edward Brettholz, Clinical Assistant Professor of Medicine, NYU School of Medicine. Keywords for this
12/11/17 - FDA Approves Investigational Device Exemption for SetPoint Bioelectronic Therapy Clinical Study in Rheumatoid Arthritis
SetPoint Medical, a clinical-stage biomedical technology company developing an implantable bioelectronic medicine therapy for chronic inflammatory diseases, has received Investigational Device Exemption approval from the U.S. Food& Drug Administration to initiate a pilot trial in the U.S. for patients with drug refractory rheumatoid arthritis.
12/11/17 - Intersect ENT Announces FDA Approval of SINUVA? Sinus Implant, a New In-Office Treatment Option for Recurrent Nasal Polyps
Intersect ENT, Inc., a company dedicated to transforming care for patients with ear, nose and throat conditions, today announced that it has received approval from the U.S. Food and Drug Administration for the SINUVA? Sinus Implant, a new targeted approach to treating recurrent nasal polyp disease in patients who have had previous ethmoid sinus s
12/11/17 - Janssen Submits Supplemental New Drug Application to FDA Seeking New Indications for XARELTO (rivaroxaban) for Patients with Chronic Coronary and/or Peripheral Artery Disease (CAD/PAD)
Janssen Research& Development, LLC today announced it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for two new XARELTO vascular indications: reducing the risk of major cardiovascular events such as CV death, heart attack or stroke in patients with chronic coronary and/or peripheral artery disease,
12/11/17 - MIM Software Receives FDA 510k Clearance for Post-Treatment Dosimetry of Yttrium-90 Microspheres
By a News Reporter-Staff News Editor at Pharma Business Week MIM Software Inc., a leading global provider of medical imaging software, announced it has received 510 clearance from the U.S. Food and Drug Administration for post-treatment dosimetry of Yttrium-90 microspheres. MIM SurePlan? LiverY90 provides timesaving tools for liver and tumor...
12/11/17 - Stimwave Granted New FDA 510k Clearance for the SandShark Injectable Anchoring System, Fixating Stimulators without Surgery
By a News Reporter-Staff News Editor at Pharma Business Week Stimwave LLC, a medical device manufacturer and independent research institute headquartered in South Florida, announced the SandShark Injectable Anchor System received the U. S. Food and Drug Administration's 510 clearance. "The SandShark Injectable Anchor System is a ground-breaking.
12/11/17 - Upsher-Smith Launches KLOR-CON Powder Potassium Chloride For Oral Solution
By a News Reporter-Staff News Editor at Pharma Business Week Upsher-Smith Laboratories, LLC. announced the launch of KLOR-CON Powder for oral solution, 20 mEq. The Company received approval of an abbreviated new drug application from the U.S. Food and Drug Administration for this product, which will be marketed and distributed by Upsher-Smith.
12/10/17 - Repatha & Praluent: A Tale Of Two Rivals...
THOUSAND OAKS- Rivalry is the life of trade, and it makes for some of the most compelling stories. Praluent, developed by Sanofi and Regeneron Pharmaceuticals Inc., was approved by the FDA on July 24, 2015, while Repatha, developed by Amgen Inc., received FDA approval on August 27, 2015. However, in Europe, Repatha was the first to receive the regu
Articles(s): 1 - 25 of 55     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