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 The leading web portal for pharmacy resources, news, education and careers April 25, 2015
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - April 25, 2015

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 28     Next >>     Go To Page:

4/24/15 - Celgene : FDA Approves Pomalyst Label Update Incl. PFS And OS Benefits
SUMMIT- Celgene Corp. announced that it has fulfilled the accelerated approval requirements for Pomalyst based on results from MM-003, an international phase III study of POMALYST plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma patients. Pomalyst, in combination with dexamethasone is approved for..
4/24/15 - DGAP-News: Eckert & Ziegler's SagiNova(R) afterloader receives FDA market clearance [Construction Machinery Middle East (United Arab E]
-DGAP-News: Eckert& Ziegler Strahlen- und Medizintechnik AG/ Key word: Regulatory Approval Eckert& Ziegler's SagiNova (R) afterloader receives FDA market clearance. Eckert& Ziegler's SagiNova (R) afterloader receives FDA market clearance. Eckert& Ziegler has received market clearance from the U.S. Food and Drug Administration for its new SagiNova (
4/24/15 - Eli Lilly: FDA Grants Fourth Approval For Cyramza
INDIANAPOLIS- Eli Lilly and Co on Friday said it received its fourth U.S. Food and Drug Administration approval for CYRAMZA, which is also now indicated in combination with FOLFIRI chemotherapy for the treatment of patients with metastatic colorectal cancer with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a...
4/24/15 - Hospira Leadership Presents at Preeminent European Biosimilars Forum, Announces New White Paper on Extrapolation
Hospira, Inc., a world leader in the development of biosimilar therapies, spoke about the importance of extrapolation in bringing biosimilars to patients today at the European Generics Association annual European Biosimilars Group conference in London. Speaking at the EGA conference, Sumant Ramachandra, M.D., Ph.D., senior vice president and chie
4/24/15 - Lilly's CYRAMZA (ramucirumab) Receives Fourth FDA Approval
"CYRAMZA now has approvals in advanced or metastatic forms of three of the world's most common and deadly cancers gastric, non-small cell lung, and colorectal with four FDA approvals received in just over a year," said Sue Mahony, Ph.D., senior vice president and president, Lilly Oncology. Dr. Mahony added, "We are also pleased with the effic
4/23/15 - Bruker Announces FDA Clearance for Second, Expanded Claim for the MALDI Biotyper CA System
By a News Reporter-Staff News Editor at Politics& Government Week Bruker announced that it has received 510 clearance from the US Food and Drug Administration for library and methods expansion for the MALDI Biotyper CA System, sold in the United States for clinical microbiology. In November 2013, Bruker received FDA 510 clearance for a first clai
4/23/15 - Coloplast Titan Inflatable Penile Prosthesis Approved for Ectopic Placement
Coloplast, a leading medical device company, announced it has received approval from The Center for Devices and Radiological Health of the Food and Drug Administration for changes in labeling of the Titan Inflatable Penile Prosthesis instruction for use to incorporate ectopic reservoir placement. Impact on the Clinical Community. Paul Perito, Chi
4/23/15 - DGAP-News: Eckert & Ziegler's SagiNova(R) afterloader receives FDA market clearance
DGAP-News: Eckert& Ziegler Strahlen- und Medizintechnik AG/ Key word: Regulatory Approval Eckert& Ziegler's SagiNova (R) afterloader receives FDA market clearance 23.04. 2015/ 07:45- Press release Eckert& Ziegler's SagiNova (R) afterloader receives FDA market clearance Berlin, Apri
4/23/15 - DGAP-News: Eckert & Ziegler's SagiNova(R) afterloader receives FDA market clearance (english)
Eckert& Ziegler's SagiNova (R) afterloader receives FDA market clearance DGAP-News: Eckert& Ziegler Strahlen- und Medizintechnik AG/ Key word: Regulatory Approval Eckert& Ziegler's SagiNova (R) afterloader receives FDA market clearance 23.04. 2015/ 07:45- Press release Eckert& Zieg
4/23/15 - FDA Approves Breast Tomosynthesis Option for Siemens Mammography Platform
The Food and Drug Administration has approved the MAMMOMAT Inspiration with Tomosynthesis Option the breast tomosynthesis add-on option for Siemens Healthcare s MAMMOMAT Inspiration digital mammography platform. Siemens breast tomosynthesis algorithm reconstructs multiple 2 D images of the breast into an approximation of a 3 D image to ena
4/23/15 - PharmaCyte Awaits Pivotal U.S. Study Results; FDA Approves Breast Tomosynthesis Option
PharmaCyte even made headlines in the diabetes industry two weeks ago after a study was published that stated its Melligen cell line could produce insulin in diabetic mice. This news essentially means the company is well on its way to reversing the diabetes condition if the cell line proves to be safe, and those cells can be encapsulated using Phar
4/23/15 - POMALYST (pomalidomide) Label Update Including Progression-Free and Overall Survival Benefits Approved by U.S. FDA
Celgene Corporation today announced it has fulfilled the accelerated approval requirements for POMALYST based on results from MM-003, an international phase III study of POMALYST plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma patients. POMALYST has been able to help thousands of patients...
4/22/15 - CASMED Receives FDA Approval for FORE-SIGHT ELITE; Provectus Opens Patient Enrollment of PV-10 for Melanoma
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 15, 2015.{ nfg} CAS Medical Systems, Inc., a leader in medical devices for non-invasive patient monitoring, announces receipt of an expanded label for its FORE-SIGHT ELITE oximeters from the FDA to include its new medium and small sensors for
4/22/15 - FDA Announces Availability of Safety, Effectiveness Summaries for Premarket Approval Applications for Medical Devices
WASHINGTON, April 22 The Department of Health& Human Services published the following notice in the Federal Register from the Food& Drug Administration:. A Notice by the Food and Drug Administration on 04/22/2015. FDA -2014- M-1452, FDA -2014- M-1596, FDA -2014- M-1597, FDA -2014- M-1599, FDA -2014- M-1735, FDA -2014- M-1736, FDA -2014- M-2042, F
4/22/15 - Great Basin Receives FDA 510(k) Clearance for Group B Strep Molecular Diagnostic Test
Great Basin Scientific, Inc., a molecular diagnostics company, today announced that the U.S. Food and Drug Administration has granted clearance for its molecular diagnostic test for Group B Streptococcus. This is Great Basin's second assay to be cleared by the FDA. "Receiving FDA clearance for our GBS test represents a significant milestone for Gr
4/22/15 - Perrigo Announces FDA Approval and Upcoming Launch of the AB Therapeutic Equivalent to Exalgo
By a News Reporter-Staff News Editor at Biotech Week Perrigo Company plc announced that it has received final approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for hydromorphone HCI extended-release tablets 8 mg, 12 mg and 16 mg. The FDA concluded that Perrigo's products are therapeutically equivalent to.
4/22/15 - Soligenix Announces FDA Protocol Clearance of SGX203; Biogen Reports New Anti-LINGO-1
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 14, 2015.{ nfg} Soligenix, Inc., announced an agreement has been reached with the US Food and Drug Administration on the design of a pivotal, Phase 3 clinical trial evaluating its product, SGX203, in the treatment of pediatric Crohn's disease. SG
4/22/15 - Thoratec Receives Approval From FDA For Full Expansion Of HeartMate III?; PlasmaTech Announces $5 million private placement
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 2, 2015.{ nfg} Thoratec Corporation, announced that it received final approval from the FDA to broaden enrollment of the HeartMate III U.S. clinical trial of up to 1,028 patients in up to 60 sites. Mandeep Mehra, Medical Director of the Brigham a
4/20/15 - Actavis Announces FDA Approval of Expanded Label for BOTOX (OnabotulinumtoxinA) for the Treatment of Upper Limb Spasticity in Adults
The FDA also approved an increase to the maximum BOTOX cumulative dose within three months from 360 to 400 units in adults treated for one or more indications. BOTOX is the first and only neurotoxin approved by the FDA for the treatment of upper limb spasticity a debilitating neurological condition, producing muscle stiffness that can resu
4/20/15 - Actavis: FDA Approves Expanded Label For BOTOX
WASHINGTON- Actavis plc announced that the U.S. FDA has approved an expansion of the BOTOX label for the treatment of adults with upper limb spasticity. The FDA also approved an increase to the maximum BOTOX cumulative dose within three months from 360 to 400 units in adults treated for one or more indications.
4/20/15 - Cardiovascular Systems Receives FDA Clearance for New Peripheral Diamondback Device
Cardiovascular Systems, Inc., announced today that it has received FDA clearance for the new 4 French 1.25 Solid Diamondback 360 Peripheral Orbital Atherectomy System for the treatment of peripheral artery disease. We are committed to advancing CSI s proven OAS technology, and redefining minimally invasive therapies, said David L. Marti
4/20/15 - Direct Flow Medical, Inc. Announces FDA Approval to Broaden SALUS U.S. Pivotal Trial
By a News Reporter-Staff News Editor at Clinical Trials Week Direct Flow Medical , Inc., a transcatheter heart valve innovator focused on improving patient outcomes, has received Investigational Device Exemption approval from the U.S. Food and Drug Administration to broaden its SALUS Trial, including the addition of high risk patients and rando
4/20/15 - FDA approves first-of-its-kind corneal implant to improve near vision in certain patients
Release date- 17042015- The U.S. Food and Drug Administration today approved the KAMRA inlay, a device implanted in the cornea of one eye to improve near vision in certain patients with presbyopia. It is the first implantable device for correction of near vision in patients who have not had cataract surgery. 'Presbyopia is a natural part of aging a
4/20/15 - FDA Approves New Formulation of MINOCIN (minocycline) for Injection
The Medicines Company today announced that the U.S. Food and Drug Administration has approved a supplemental new drug application for a new formulation of MINOCIN for Injection. The FDA has also granted Qualified Infectious Disease Product designation for the new formulation of MINOCIN for Injection under the Generating Antibiotic Incentives Now
4/20/15 - LUPIN - FOLLOW-UP CALL: COMPETITION WILL BITE
Lupin Ltd is expected to face stiff competition from the launch of generic Suprax by Aurobindo Pharmaceuticals. The US Food and Drug Administration has approved the generic version of Aurobindo. The company has obtained three product approvals from the FDA in Jan- Mar 2015.
Articles(s): 1 - 25 of 28     Next >>     Go To Page:


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