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About 1044 results for "fda"

Glenmark receives US FDA's nod for antifungal cream
Business Standard

Beximco Pharma gets all-clear from FDA to sell another drug in...

The company released a statement on Monday saying that this is the second product from Beximco Pharma to be approved by the FDA after Carvedilol, a prescription drug for treating hypertension, which was approved in July 2015. This approval will ... 4 Traders, 20 minutes ago
Glenmark receives US FDA's nod for antifungal cream Business Standard, 1 day ago

6,132 images for fda

Cancer Therapy Advisor, 17 hours ago
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US FDA buys Cobalt's TRS100 transmission Raman instrument for quantitative analysis of tablets & capsules

The United States Food and Drug Administration (FDA) has purchased Cobalt's TRS100 transmission Raman instrument for use by the Division of Pharmaceutical Analysis (DPA). Transmission Raman spectroscopy (TRS) is an increasingly-used alternative to ...
 PharmaBiz9 minutes ago

Medacta Announces First Surgeries With MySpine Low Profile Guide Following FDA Clearance

CHICAGO--( BUSINESS WIRE )--Medacta International, the privately held, family-owned global leader in the design of innovative joint replacement and spine surgery products, announced today the successful completion of the first U.S. surgeries by Dr. minutes ago
Medical Devices Business Review

Ethicon gets expanded FDA approval for Evarrest Fibrin Sealant Patch

2016 The US Food and Drug Administration (FDA) has approved an expanded indication for Ethicon's Evarrest Fibrin Sealant Patch, which leverages biologics to rapidly and reliably stop problematic bleeding during surgery. The expanded indication ...
 Medical Devices Business Review54 minutes ago EVARRESTĀ® Fibrin Sealant Patch Gains FDA Approval on Expanded Indication for General Hemostasis  4 Traders23 hours ago Philips seeks FDA approval for expanded indications of IntelliSite digital pathology solution  Medical Devices Business Review2 days ago Ethicon Release: EVARREST Fibrin Sealant Patch Gains FDA Approval on Expanded Indication for General Hemostasis  BioSpace20 hours ago
American Academy of Ophthalmology

Merck's Keytruda Receives First-Line Nod From FDA In Lung Cancer: What Does It Mean?

For lung cancer in 2016, the immune checkpoint inhibitor space has grown so rapidly that it's hard to keep everything straight. Recently, Roche's PD-L1 inhibitor atezolizumab was approved for previously treated metastatic disease by the FDA. And two ...
 Seeking Alpha12 hours ago U.S. FDA approves Merck's lung cancer drug as first-line treatment  Reuters UK1 day ago FDA approves first prefilled syringe of ranibizumab  American Academy of Ophthalmology10 hours ago Immunotherapy drug approved by FDA as first-line treatment for non-small cell lung cancer  News-Medical.Net13 hours ago
Proactive Investors USA

GSK submits biologics licence application to FDA for shingles vaccine

GlaxoSmithKline (GSK) has submitted a biologics licence application to the US Food and Drug Administration (FDA) for approval of its candidate shingles vaccine, Shingrix, to help prevent herpes zoster (shingles) in people aged 50 years or more. ...
 Pharmaceutical Technology1 day ago FDA expert lashes out at 'worrisome' Sarepta approval in JAMA  FierceBiotech20 hours ago Harvard Experts Fret Over the Fallout From FDA???s OK for Sarepta???s Controversial DMD Drug  BioSpace22 hours ago Glaxo Is Asking the FDA to Approve This New Shingles Drug  Fortune1 day ago
Insurance Journal

FDA, Hospitals Work to Improve Data Collection about Medical Devices

The U.S. Food and Drug Administration (FDA) is looking to improve the way it works with hospitals to modernize and streamline data collection, specifically safety data, about medical devices. In a blog post , Jeffrey Shuren, M.D., director of ...
 Healthcare Informatics Online16 hours ago FDA seeks to intervene in device harm reporting  Fierce Health IT18 hours ago U.S. FDA seeks to improve hospital reporting of device injuries  Reuters UK1 day ago FDA Cites Hospitals for Under-Reporting of Injuries from Medical Devices  Insurance Journal22 hours ago

FDA approves Spineology's Rampart Duo interbody fusion system

Spineology has secured approval from the US Food and Drug Administration (FDA) for its Rampart Duo interbody fusion system. Rampart Duo is claimed to be the first device of its kind to combine PEEK, titanium, and graft containment mesh elements. ...
 Medical Devices Business Review3 hours ago Spineology wins FDA 510(k) for Rampart Duo interbody fusion device  MassDevice13 hours ago FDA Green Lights Spineology Inc.'s Rampart Duo Interbody Fusion System  BioSpace18 hours ago Spineology Announces FDA Clearance of Rampart Duo Interbody Fusion System  Digital Journal22 hours ago

QUIDEL : Receives FDA Clearance for Its New Solana(R) Strep Complete Assay for Rapid and Qualitative Detection and Differentiation of S. pyogenes (Group A Beta-Hemolytic Streptococcus) and S. dysgalactiae (Pyogenic Group C and G Beta-Hemolytic Streptococc

SAN DIEGO, CA -- (Marketwired) -- 10/25/16 -- Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance ...
 4 Traders16 hours ago FDA approves Medtronic's smaller HawkOne 6F device to treat PAD patients  Medical Devices Business Review1 day ago Medtronic wins FDA nod for lower-profile HawkOne atherectomy device  MassDevice1 day ago Medicare receives FDA 510(k) clearances for components to address pediatric deformity  Healio1 day ago
European Pharmaceutical Review

FDA approves Roche's cobas MPX test for use with cobas 6800/8800 systems

The FDA has approved Roche's cobas MPX test for use on the cobas 6800 and 8800 systems, according to a news release from the company.The cobas MPX is a nucleic acid test for the detection of HIV, hepatitis B virus and hepatitis C virus in blood ...
 Healio15 hours ago FDA approves Roche's blood screening assay for donor screening  European Pharmaceutical Review1 day ago FDA Clears Ortho Clinical Diagnostics' ORTHO VISION Max Analyzer for High-Volume Transfusion Medicine Labs  BioSpace1 day ago Ortho Clinical's automated blood analyzer gets FDA approval  Medical Devices Business Review1 day ago
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