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 The leading web portal for pharmacy resources, news, education and careers January 20, 2019
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - January 20, 2019

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 250     Next >>     Go To Page:

12/21/18 - CathWorks FFRangio? System Receives U.S. FDA Clearance
Enables non-invasive, objective functional evaluation of multi-vessel coronary artery disease. KFAR-SABA, Israel& ALISO VIEJO, Calif. CathWorks announced today that its FFRangio? System received United States Food& Drug Administration 510 clearance. Jim Corbett, CathWorks CEO said, The FDA clearance of CathWorks FFRangio is a significant m
12/20/18 - American Red Cross Receives Biologics License Application Approval For INTERCEPT Platelets
By a News Reporter-Staff News Editor at Biotech Week Cerus Corporation announced that the American Red Cross has received approval by the U.S. Food and Drug Administration for their first biologics license application for interstate distribution of platelets that have been pathogen-reduced with INTERCEPT Blood Systems. "This BLA approval is a ke
12/20/18 - Aquestive Therapeutics Provides End of Year Business Update, Including Progress of its Proprietary CNS Assets, Financial and Legal Matters
Aquestive Therapeutics, Inc., a specialty pharmaceutical company pharmaceutical company focused on identifying, developing, and commercializing differentiated products to solve therapeutic problems, is reporting positive developments across its business. In November 2018, the company received approval from the U.S. Food and Drug Administration fo
12/20/18 - Assertio Therapeutics Announces Submission of NDA for FDA Approval of Cosyntropin Depot
Assertio Therapeutics, Inc. today announced that it has submitted to the U.S. Food and Drug Administration a 505 New Drug Application for its novel injectable formulation of cosyntropin depot with its partner, West Therapeutic Development, LLC. Our filing strategy for cosyntropin depot is the most efficient and expeditious way to make this imp
12/20/18 - AstraZeneca - LYNPARZA approved by US FDA for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer
AstraZeneca and Merck& Co., Inc., today announced that the US Food and Drug Administration has approved LYNPARZA for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial respons
12/20/18 - AstraZeneca and Merck - LYNPARZA Approved by FDA for First-Line Maintenance Therapy in BRCA-Mutated Advanced Ovarian Cancer
KENILWORTH- AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved LYNPARZA for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary...
12/20/18 - BD Completes Molecular Portfolio for GI Infection With New Viral Panel
BD, a leading global medical technology company, today announced the U.S. Food and Drug Administration 510 clearance of its BD MAX? enteric viral panel, a molecular diagnostic test for the direct qualitative detection and differentiation of enteric viral pathogens that cause viral gastroenteritis. Norovirus is the most common viral cause and ac
12/20/18 - FDA Approves Merck's KEYTRUDA for the Treatment of Adult and Pediatric Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma
KENILWORTH- Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved KEYTRUDA, Merck' s anti-PD-1 therapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma, based on the results of the Cancer Immunotherapy Tr
12/20/18 - FDA Clears HSV 1 and 2 Assay from ELITechGroup
The molecular test detects and differentiates the nucleic acid of herpes simplex viruses 1 and 2 isolated from swab specimens from cutaneous or mucocutaneous lesions on symptomatic patients.
12/20/18 - Findings from Leiden University Medical Center Update Understanding of Duchenne Muscular Dystrophy (A Sequel to the Eteplirsen Saga: Eteplirsen Is Approved in the United States but Was Not Approved in Europe)
According to news reporting originating in Leiden, Netherlands, by NewsRx journalists, research stated, "Eteplirsen was approved for the treatment of eligible patients with Duchenne muscular dystrophy in September 2016 in one of the most, if not the most, controversial approvals ever made by the Food and Drug Administration of the United States.
12/20/18 - GenMark Diagnostics Receives FDA 510(k) Market Clearance for its ePlex Blood Culture Identification Gram-Positive Panel
GenMark Diagnostics, Inc., a leading provider of automated, multiplex molecular diagnostic testing systems, today announced that it has received FDA 510 market clearance from the U.S. Food and Drug Administration for its ePlex Blood Culture Identification Gram-Positive Panel. The ePlex BCID-GP Panel includes important BSI causing pathogens and un
12/20/18 - Iradimed Announces FDA Clearance of Wireless Invasive Blood Pressure
Winter Springs- IRADIMED CORPORATION, a leader in the development of innovative magnetic resonance imaging medical devices, today announced FDA 510 clearance of its 3883 MRI-compatible invasive blood pressure module for use with its 3880 MRI compatible patient vital signs monitoring system. IRADIMED designed the 3880 MRI-compatible patient vital...
12/20/18 - Lynparza approved by US FDA for 1st-line maintenance therapy in BRCA-mutated advanced ovarian cancer
AstraZeneca and Merck& Co., Inc., Kenilworth, N.J., US today announced that the US Food and Drug Administration has approved Lynparza for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete
12/20/18 - Treatment for Chronic Idiopathic Constipation Receives FDA Approval [Syrian Arab News Agency]
Officials with the FDA have approved prucalopride for the treatment of chronic idiopathic constipation, according to a press release issued by the company. According to Shire, an estimated 35 million adults are living with CIC, affecting roughly 14% of the adult population. Prucalopride, a selective serotonin-4 receptor agonist, provides an oral tr
12/20/18 - Veloxis Pharmaceuticals - FDA Approves New Indication for ENVARSUS XR
Veloxis Pharmaceuticals announced today that the U.S. Food& Drug Administration approved a new indication for Envarsus XR to prevent organ rejection in de novo kidney transplant patients in combination with other immunosuppressants. Envarsus XR was approved for the prophylaxis of organ rejection in kidney transplant patients converted from...
12/20/18 - XenoTherapeutics to Start First Human Trial of Xeno-Skin?, a Novel Xenotransplantation Treatment for Severe Burns
By a News Reporter-Staff News Editor at Blood Weekly XenoTherapeutics, a life science company whose mission is to solve the global shortage of organs and tissues for transplants, announced that the U.S. Food and Drug Administration has cleared the company's Investigational New Drug application allowing clinical studies of Xeno-Skin? to be initi
12/19/18 - Alcon Acquires Privately-held Tear Film Innovations
BASEL- Alcon, a division of Novartis AG, said Wednesday that it has acquired Tear Film Innovations, Inc., a privately-held company and manufacturer of the iLux Device, a therapeutic device used to treat Meibomian Gland Dysfunction, a leading cause of dry eye. The iLux Device received 510 clearance from the U.S. Food and Drug Administration in Decem
12/19/18 - BRACAnalysis CDx Approved by U.S. Food and Drug Administration as Companion Diagnostic for AstraZeneca's Lynparza (olaparib) in Patients with Advanced-Stage, BRCA-Mutated Ovarian Cancer
Myriad Genetics, Inc., a leader in molecular diagnostics and personalized medicine, today announced that the U.S. We congratulate AstraZeneca and Merck on obtaining FDA approval of Lynparza for patients with BRCA m advanced ovarian cancer, and we are excited to expand the use of BRACAnalysis CDx as the companion diagnostic test in this populat
12/19/18 - Celltrion and Teva`s Herceptin biosimilar secures FDA approval in breast cancer [Sudan Tribune]
Israeli and South Korean-based drug makers Teva and Celltrion are set to move in on the market share occupied by Roche and Genentechs Herceptin with the announcement that their own biosimilar version of the drug has received approval from the FDA. Biosimilars are of growing importance to the oncology community and the approval of Herzuma may provid
12/19/18 - ELBIT IMAGING LTD. ANNOUNCES THAT INSIGHTEC RECEIVED FDA APPROVAL OF EXABLATE NEURO FOR THE TREATMENT OF TREMOR-DOMINANT PARKINSON'S DISEASE
Elbit Imaging Ltd. announced today that Insightec Ltd. informed that the Center for Devices and Radiological Health of the Food and Drug Administration has approved an expansion of the indication of Exablate Neuro to include the treatment of patients with tremor-dominant Parkinson s disease. The Company holds approximately 63% of the share cap
12/19/18 - FDA approves Lynparza as 1L maintenance therapy
19 December 2018 18:30 GMT. Lynparza approved by US FDA for 1st- line maintenance therapy in BRCA-mutated advanced ovarian cancer. AstraZeneca and Merck& Co., Inc., Kenilworth, N.J., US today announced that the US Food and Drug Administration has approved Lynparza for the maintenance treatment of adult patients with deleterious or suspected deleter
12/19/18 - FDA Approves Merck's KEYTRUDA (pembrolizumab) for the Treatment of Adult and Pediatric Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma, a Rare Form of Skin Cancer
Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved KEYTRUDA, Merck s anti-PD-1 therapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma, based on the results of the Cancer Immunotherapy Trials Netwo
12/19/18 - FDA Approves New Indication for ENVARSUS XR (tacrolimus extended-release tablets)
Veloxis Pharmaceuticals announced today that the U.S. Food& Drug Administration approved a new indication for Envarsus XR to prevent organ rejection in de novo kidney transplant patients in combination with other immunosuppressants. Chief Scientific Officer at Veloxis Pharmaceuticals, Inc.. The FDA's approval is based on the Phase 3 clinical...
12/19/18 - FDA Clears iCAD's ProFound AI for Digital Breast Tomosynthesis
Nashua, N.H.-based iCAD, Inc. has announced that the U.S. FDA has cleared ProFound AI, its deep-learning, cancer detection software for digital breast tomosynthesis, making the technology available for commercial sales and clinical use in the United States.
12/19/18 - Glenmark Pharmaceuticals receives ANDA approval for Fluocinolone Acetonide Oil, 0.01%
Glenmark's current portfolio consists of 146 products authorized for distribution in the U.S. marketplace and 54 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio
Articles(s): 1 - 25 of 250     Next >>     Go To Page:


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