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 The leading web portal for pharmacy resources, news, education and careers October 22, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - October 22, 2014

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 77     Next >>     Go To Page:

10/22/14 - FDA Grants Clearance to Proceed with Clinical Study - New Drug Candidate from Vivolux Could Overcome Drug Resistance
By a News Reporter-Staff News Editor at Biotech Week Vivolux, a pharmaceutical company specialized in cancer treatment, announced that the FDA has granted clearance to proceed with VLX1570 to clinical phase I/II for treatment against relapsed and/or refractory multiple myeloma. The clinical study will be conducted in collaboration with the Memori
10/22/14 - Ferring Pharmaceuticals Inc. Receives FDA Approval For New Cranberry Flavor Of PREPOPIK Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric...
Ferring Pharmaceuticals Inc. Receives FDA Approval For New Cranberry Flavor Of PREPOPIK Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid. To offer an alternative choice in bowel preparation, Ferring Pharmaceuticals Inc. will introduce a new cranberry flavor option of PREPOPIK in January 2015. Gastroenterology business unit at Ferri
10/22/14 - Insys Gets DEA Approval to Produce Pharmaceutical Cannabidiol; Posts Status of Its Cannabinoid Program [Professional Services Close - Up]
Insys Therapeutics, Inc. reported that its Food and Drug Administration inspected and Drug Enforcement Agency approved facility in Round Rock, Texas, has received DEA approval to manufacture synthetically its pharmaceutical grade Cannabidiol. Insys believes these quantities are sufficient to pursue its CBD development program as currently planned.
10/22/14 - Quidel Secures FDA Clearance for Its Lyra Molecular PCR Assay for the Detection of Human Parainfluenza Viruses (HPIV), Types 1, 2 and 3 [Professional Services Close - Up]
Quidel reported that it has received 510 clearance from the United States Food and Drug Administration to market its Lyra Parainfluenza Assay, a real-time PCR test for the qualitative detection and identification of human parainfluenza virus infections for virus types 1, 2, or 3 viral RNA extracted from nasal swab and nasopharyngeal swab specimens.
10/22/14 - Switzerland : Novartis announces FDA Advisory Committee unanimously recommends approval of AIN457 (secukinumab) for patients with moderate-to-severe... [TendersInfo (India)]
Switzerland: Novartis announces FDA Advisory Committee unanimously recommends approval of AIN457 for patients with moderate-to-severe plaque psoriasis. Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the US Food and Drug Administration today voted unanimously to support the approval of AIN457, a selective...
10/21/14 - AnthroTronix Secures FDA Clearance for Brain Health Assessment Tool [Health & Beauty Close - Up]
"We are pleased that DANA has sought and received FDA clearance, leading the way for this type of game-changing technology," said Corinna Lathan, founder and CEO of AnthroTronix. "With the steady growth of the mHealth movement, technology that has evidence and science-based functionality is critical," said Duke University Medical Center's Murali D
10/21/14 - BioSpecifics Tech. Reports FDA Approval Of SBLA For XIAFLEX
WASHINGTON- The U.S. Food and Drug Administration or FDA has approved the supplemental Biologics License Application or sBLA submitted by BioSpecifics Technologies Corp.' s partner, Auxilium Pharmaceuticals Inc., for XIAFLEX for the treatment of up to two Dupuytren's contracture cords in the same hand during a single treatment visit.
10/21/14 - BioSpecifics Technologies Corp. Announces FDA Approval of sBLA for XIAFLEX for the Concurrent Treatment of Two Dupuytren's Contracture Cords
BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX in the EU, today announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application submitted by BioSpecifics' partner, Auxilium...
10/21/14 - Boston Scientific Receives FDA And CE Mark Approval For New CoverEdge? Surgical Leads For The Precision Spectra? Spinal Cord Stimulator (SCS) System
Boston Scientific Corporation has received U.S. Food and Drug Administration and CE Mark approval for the CoverEdge? 32 and CoverEdge? X 32 Surgical Leads, the world's first 32- contact surgical leads designed to blanket the spinal cord for unprecedented pain coverage. Boston Scientific is introducing the CoverEdge Surgical Leads at the Congr
10/21/14 - Boston Scientific's New Surgical Leads Receive FDA, CE Mark Approval
WASHINGTON- Boston Scientific Corp. Tuesday said its surgical leads- CoverEdge 32 and CoverEdge X 32- have received U.S. Food and Drug Administration approval as well as the CE Mark from European Union to provide software-guided stimulation to the spinal cord for relieving pain. The company said CoverEdge 32 and CoverEdge X were superior to existin
10/21/14 - NBIX For The Long Haul, RegeneRx Catches Investors' Eyes, NewLink Inks New Deal
WASHINGTON- Auxilium Pharmaceuticals Inc.' s supplemental Biologics Application for XIAFLEX for the treatment of up to two Dupuytren's contracture joints in the same hand during a single treatment visit has been approved by FDA. Auxilium Pharma is all set to be acquired by Endo International plc for roughly $2.6 billion, and the transaction is expe
10/21/14 - Novartis announces FDA Advisory Committee unanimously recommends approval of AIN457 (secukinumab) for patients with moderate-to-severe plaque psoriasis
Release date- 20102014- Basel,- Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the US Food and Drug Administration today voted unanimously to support the approval of AIN457, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemi
10/21/14 - Palo Alto Plastic Surgeon Discusses Recent FDA Alert About Non-Approved Filler
According to a recent FDA announcement, some medical professionals are reportedly using an HA-based formula as a dermal filler despite the fact it is not designed for this purpose. The FDA alert states that a hyaluronic acid-based gel called Expression or Expression Injectable, which is designed for use as an intranasal splint for rhinoplasty, has
10/21/14 - TONIX PHARMACEUTICALS HOLDING CORP. FILES (8-K) Disclosing Other Events, Financial Statements and Exhibits
On October 21, 2014, Tonix Pharmaceuticals Holding Corp. issued a press release announcing that the Company has received clearance from the U.S. Food and Drug Administration of its Investigational New Drug application to study TNX-201 for the treatment of episodic tension-type headache. A clinical pharmacology study of TNX-201 in healthy volunteers
10/21/14 - Tonix Pharmaceuticals Receives IND Clearance for TNX-201 in Episodic Tension-Type Headache
Tonix Pharmaceuticals Holding Corp. announced today that the U.S. Food and Drug Administration has cleared its Investigational New Drug application to study TNX-201 for the treatment of episodic tension-type headache. Tonix will evaluate the safety, tolerability, and pharmacokinetics of TNX-201 in a healthy volunteers study to be completed before
10/21/14 - West's Vial2Bag DC Device Receives U.S. FDA 510(k) Clearance and CE Mark
West Pharmaceutical Services, Inc., a global leader in innovative solutions for injectable drug administration, has received 510 clearance of the Vial2Bag DC device from the United States Food and Drug Administration, and also the CE Mark for the European Union. Our new Vial2Bag DC device simplifies the IV admixture process and eliminates the
10/20/14 - Auxilium Pharmaceuticals, Inc. Announces XIAFLEX Now Approved For The Concurrent Treatment Of Up To Two Affected Joints In The Same Hand In Dupuytren's Contracture Patients
Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration has approved a supplemental Biologics Application for XIAFLEX for the treatment of up to two Dupuytren's contracture joints in the same hand during a single treatment visit. XIAFLEX is a biologic approved in the U.S.,
10/20/14 - BioDelivery Sciences to Provide BUNAVAIL Launch Update
By a News Reporter-Staff News Editor at Pharma Business Week BioDelivery Sciences International, Inc. will host an investor update conference call and webcast to discuss the launch of BUNAVAIL? buccal film which has been approved by the U.S. Food and Drug Administration for the maintenance treatment of opioid dependence. Since FDA approval of B
10/20/14 - Boehringer Ingelheim's OFEV Approved by FDA as a Kinase Inhibitor to Treat Idiopathic Pulmonary Fibrosis [Professional Services Close - Up]
Boehringer Ingelheim Pharmaceuticals, Inc. reported that the U.S. Food and Drug Administration approved OFEV capsules for oral use for the treatment of idiopathic pulmonary fibrosis. According to a release from the Company, granted Breakthrough Therapy designation during its review by the FDA, OFEV, capsules for oral use, taken twice daily, is the
10/20/14 - FDA Approves Dexcom SHARE?, the First Remote Mobile Communications Device Used for Continuous Glucose Monitoring (CGM)
Dexcom, Inc., a leader in continuous glucose monitoring for patients with diabetes, announced today that it has received U.S. Food and Drug Administration approval for its CGM remote mobile communications device: Dexcom SHARE. Dexcom SHARE represents a significant advance in diabetes care by allowing people with diabetes to share important gluco
10/20/14 - Fitch: FDA Drug Approvals Up for Breakthrough Entities, Biologics
CHICAGO& NEW YORK Link to Fitch Ratings' Report: Global Pharmaceutical R&D Pipeline. The number of NME approvals by the FDA during the first nine months in 2014 was up from the first nine months of 2013. The FDA cleared 33 novel medicines for U.S. marketing during the first five months of 2014, compared with 17 in 2013. The FDA has approved sev
10/20/14 - GNW-News: Novartis announces FDA Advisory Committee unanimously recommends approval of AIN457 (secukinumab) for patients with moderate-to-severe plaque psoriasis (english)
Novartis announces FDA Advisory Committee unanimously recommends approval of AIN457 for patients with moderate-to-severe plaque psoriasis. Novartis International AG/ Novartis announces FDA Advisory Committee unanimously recommends approval of AIN457 for patients with moderate-to-severe plaque psoriasis. 17 A inhibitor, is currently under FDA...
10/20/14 - Halozyme Receives FDA Approval For Additional Manufacturing Facilities For Hylenex Recombinant
Halozyme Therapeutics, Inc. today announced that the U.S. Food and Drug Administration has approved new contract manufacturing facilities used in the production of Hylenex recombinant. The FDA approved the use of the Cook Pharmica manufacturing facility in Bloomington, Indiana for the production of bulk rHuPH20, the active ingredient used in H
10/20/14 - Medical marijuana debate focuses on what is an approved drug, and language of proposed amendment [Naples Daily News, Fla.]
Oct. 20 NAPLES Voters will consider making Florida the 24th state and the first in the South to approve a comprehensive medical marijuana program, but opponents argue a synthetic form of marijuana already offers medical relief that's controlled by the Food and Drug Administration. The debate over medical marijuana in Florida has raged between s
10/20/14 - Neovasc Receives FDA Conditional Approval to Initiate TIARA-I Trial in US: A Multinational, Multicenter Early Feasibility Trial of the Tiara?...
By a News Reporter-Staff News Editor at Pharma Business Week Neovasc Inc. announced that it has received conditional Investigational Device Exemption approval from the U.S. Food and Drug Administration to initiate the U.S. arm of its TIARA-I Early Feasibility Trial for the Company's Tiara? transcatheter mitral valve. "We are delighted that aft
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