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 The leading web portal for pharmacy resources, news, education and careers March 29, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - March 29, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 159     Next >>     Go To Page:

3/21/17 - China Looks at Ways to Speed up Approvals for Foreign Drugs [T-break Tech (Middle East)]
In the future multinationals may no longer be required to have their drugs licensed or have completed the second or third phase of clinical trials on new drugs in their country of origin before they can begin tests in China, according to a draft document released by the China Food and Drug Administration on Friday. Manufacturers of imported drugs w
3/21/17 - Esperion Announces FDA Confirmation Regarding Regulatory Pathway to Approval for an LDL-C Lowering Indication for Bempedoic Acid [Arab News (Saudi Arabia)]
"We are very pleased to have achieved clarity from FDA regarding Esperions LDL-C lowering development program," saidTim M. Mayleben, president and chief executive officer of Esperion. Interactions with FDA also addressed the ongoing cardiovascular outcomes trial, Cholesterol Lowering via BEmpedoic Acid, an ACL-inhibiting Regimen Outcomes for bemped
3/21/17 - FDA Approves Drug to Treat Parkinson's Disease
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. The U.S. Food and Drug Administration today approved Xadago tablets as an add-on treatment for patients with Parkinson's disease who are currently taking levodopa/carbidopa and experiencing "off" episodes. "Parkinson's is a relentless
3/21/17 - FDA APPROVES XADAGO (SAFINAMIDE) FOR PARKINSONS DISEASE (PD) PATIENTS
Milan, Italy and Morristown, NJ, U.S.A.,- March 21, 2017- Newron Pharmaceuticals S.p.A., a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system and pain, and its partners Zambon S.p.A. and US WorldMeds, LLC, announced today that the Food and Drug Administration has approved
3/21/17 - FDA OKs Siemens Robotic C-Arm Angiography System
FDA has cleared the ARTIS pheno, a robotic C-arm angiography system from Siemens Healthineers created for use in minimally invasive interventional procedures. The system possesses a zen40HDR flat panel detector, GIGALIX X-ray tube, but and new 2k recording technology.
3/21/17 - KISQALI (ribociclib) Approved for the Treatment of HR+/HER2- Advanced Breast Cancer, available for order at Biologics, Inc.
Release date- 18032017- CARY, N.C.- Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, has been selected by Novartis to be a specialty pharmacy provider for KISQALI. Approved by the U.S. Food and Drug Administration on March 13, 2017, KISQALI is a kinase inhibitor indicated in combination with an aromatase inhibitor as
3/21/17 - Not All's Well With Abbott's Absorb Stent?
NORTH CHICAGO- It's been a little over eight months since Abbott Vascular Inc.' s, a division of Abbott Labs, fully absorbable stent, Absorb GT1 Bioresorbable Vascular Scaffold, received FDA approval. The FDA, which reviewed a two-year data from Abbot's pivotal clinical study evaluating the safety and effectiveness of the stent, dubbed ABSORB III,
3/21/17 - The FDA Just Approved a New Filler That's the First of Its Kind
Allergan, the pharmaceutical company behind Juvderm, just announced some pretty exciting news: One of its new fillers has been granted FDA-approval.
3/20/17 - Allergan Says FDA Approves JUV?DERM VOLLURE XC
WASHINGTON- Allergan plc. said that it has received approval from the U.S. Food and Drug Administration to market JUV?DERM VOLLURE XC, for correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over the age of 21. JUV?DERM VOLLURE XC was first approved in Europe as JUV?DERM VOLIFT in 2013. The JUV?DERM f
3/20/17 - AMGN On Watch, GALE Reports Positive Data, EBS Secures BARDA Contract
THOUSAND OAKS- Amgen Inc. on Friday reported positive results from its Repatha cardiovascular outcomes study, dubbed FOURIER. The company's cholesterol drug Repatha received FDA approval on August 27, 2015. Terming the results as a game changer, Sean Harper, executive vice president of Research and Development at Amgen, said, "Even though high-risk
3/20/17 - Esperion Announces FDA Confirmation Regarding Regulatory Pathway to Approval for an LDL-C Lowering Indication for Bempedoic Acid
"We are very pleased to have achieved clarity from FDA regarding Esperion s LDL-C lowering development program," said Tim M. Mayleben, president and chief executive officer of Esperion. Interactions with FDA also addressed the ongoing cardiovascular outcomes trial, C holesterol L owering via B E mpedoic Acid, an A CL-inhibiting R egimen Outcomes
3/20/17 - LGC Maine Standards Announces Release of VALIDATE HEPARIN Calibration Verification / Linearity Test Kit for IL ACL TOP 500 Hemostasis Test Systems
LGC Maine Standards is pleased to announce its VALIDATE HEPARIN calibration verification/ linearity test kit has received US FDA 510 clearance for use on Instrumentation Laboratory ACL TOP 500 hemostasis test systems. LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE calibration verification/ linearity
3/20/17 - Lupin launches Generic Minastrin 24 Fe chewable tablets in the US
Release date- 18032017- Mumbai, Baltimore- Pharma Major Lupin Limited announced today the launch of Mibelas 24 Fe having received an approval from the United States Food and Drug Administration earlier. Lupin's Mibelas 24 Fe is the AB rated generic equivalent of Allergan Pharmaceuticals International Limited's Minastrin 24 Fe Tablets.
3/20/17 - Mylan Receives Tentative Approval for "TLE400" Under PEPFAR
HERTFORDSHIRE, England and PITTSBURGH, March 20, 2017/ PRNewswire/ Mylan N.V., a leading global pharmaceutical company, 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 Efavirenz, Lamivudine and Tenofovir Disoproxil F
3/20/17 - Siemens Healthineers Receives FDA Premarket Approval of HCV Genotyping Test for Hepatitis C Patients
The Food and Drug Administration has granted Premarket Approval for the VERSANT (R) HCV Genotype 2.0 Assay from Siemens Healthineers. With products and solutions such as the VERSANT HCV Genotype 2.0 Assay, as well as a new name that underlines the company's pioneering spirit and its engineering expertise in the healthcare industry, Siemens Healthin
3/20/17 - Tryton Medical Receives FDA Approval for Tryton Side Branch Stent to Treat Significant Coronary Bifurcation Lesions
By a News Reporter-Staff News Editor at Pharma Business Week Tryton Medical, Inc., the leading developer of stents designed to treat coronary bifurcation lesions, announced the U.S. Food and Drug Administration has approved the company's Premarket Approval application for the Tryton Side Branch Stent for the treatment of coronary bifurcation lesi
3/20/17 - ViaDerma Receives Provisional Patent Numbers for Its FDA Registered Viabecline and Cannabis Technologies, and Seeks to Distribute its Products with a Management, Marketing and Distribution Company in Canada to Approved International Cannabis Countrie
ViaDerma, Inc., a specialty pharmaceutical company devoted to bringing new products to market, recently announced today that the President, Dr. This group will also target countries that allow the "Clinical Studies" for medical testing such as the United Kingdom and other Asian countries. Christopher Otiko is attending the Diabetic Foot Global Conf
3/18/17 - Ampio Receives Guidance from the FDA and Proposes a Path for Approval for Single-Injection Ampion for the Treatment of Pain Due to Severe...
Ampio Receives Guidance from the FDA and Proposes a Path for Approval for Single-Injection Ampion for the Treatment of Pain Due to Severe Osteoarthritis of the Knee. By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week Ampio Pharmaceuticals, Inc. announced that the Office of Tissue and Advanced Therapies, a branch of the Center
3/18/17 - Pfizer Announces Approval By The China Food And Drug Administration Of XELJANZ, The First Oral JAK Inhibitor For Adult Patients With Moderately To Severely Active Rheumatoid Arthritis [Sudan Tribune]
Pfizer China announced today that it has received approval from the Chinese Food and Drug Administration to market its oral Janus kinase inhibitor, XELJANZ, in China for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The introduction of the
3/18/17 - Toshiba Medicals New Premium Cardiovascular Ultrasound Receives FDA Clearance [Tehran Times (Iran)]
The newly FDA- cleared system is the latest addition to the premium Aplio i-series ultrasound platform, helping to elevate cardiovascular ultrasound with excellent imaging clarity and definition. The Aplio i900 presents a real breakthrough in expanding the clinical utility of ultrasound, offering cardiologists a new tool for fast, safe and confiden
3/17/17 - Astex bags milestone after Novartis cancer drug approved [Syrian Arab News Agency]
Astex Pharmaceuticals has pocketed a milestone payment from Novartis after the cancer drug the companies worked on together a decade ago secured FDA approval. The milestone was triggered when FDA signed off on the use of Kisqali as a first-line treatment for HR-positive, HER2-negative advanced breast cancer. That led to the publication of a paper o
3/17/17 - FDA Approves Merck`s Keytruda for Adult and Pediatric Patients With Classical Hodgkin Lymphoma [Sudan Tribune]
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved KEYTRUDA, the companys anti-PD-1 therapy, for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma, or who have relapsed after three or more prior lines of therapy. Under the FDAs acce
3/17/17 - FDA Approves Novartis Kisqali As Metastatic Breast Cancer Treatment [Sport360]
Reports by the American Cancer Society reveal approximately 40 percent of U.S. women battling breast tumors are affected by metastatic breast cancer. The U.S. Food and Drug Administration confirmed the approval of Kisqali, which belongs to a class of pharmaceuticals called kinase inhibitors, on March 13. According to Novartis, a month`s supply of K
3/17/17 - KISQALI (ribociclib) Approved for the Treatment of HR+/HER2- Advanced Breast Cancer, Available for Order At Biologics, Inc.
Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, has been selected by Novartis to be a specialty pharmacy provider for KISQALI . Approved by the U.S. Food and Drug Administration on March 13, 2017, KISQALI is a kinase inhibitor indicated in combination with an aromatase inhibitor as initial endocrine-based therapy
3/17/17 - Toshiba Medical's New Premium Cardiovascular Ultrasound Receives FDA Clearance
The newly FDA- cleared system is the latest addition to the premium Aplio i-series ultrasound platform, helping to elevate cardiovascular ultrasound with excellent imaging clarity and definition. The Aplio i900 presents a real breakthrough in expanding the clinical utility of ultrasound, offering cardiologists a new tool for fast, safe and confi
Articles(s): 1 - 25 of 159     Next >>     Go To Page:


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