RESOLUTION BIOSCIENCE: Resolution Liquid Biopsy Assay Receives Breakthrough Device Designation from FDA
Accelerated pathway for companion diagnostic development granted to cell-free DNA assay for detecting HRD mutations and gene deletions
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LEICA BIOSYSTEMS: Receives FDA 510(k) Clearance to Market a Digital Pathology System for Primary Diagnosis
Leica Biosystems, the global leader in pathology workflow solutions, announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its Aperio AT2 DX System for clinical diagnosis in the U.S.
CEPHEID: Receives FDA Clearance for Extragenital Claims for Xpert® CT/NG Test
On-Demand Same-Day Extragenital Testing for Chlamydia and Gonorrhea Fills Critical Unmet Need in Fight Against Rising Rates of Chlamydial and Gonorrheal Infection
LUYE PHARMA: Luye Pharma's Rykindo® NDA Filing Accepted by the U.S. FDA
Rykindo® (LY03004), Luye Pharma's innovative, independently developed Extended-Release Microspheres formulation for injection, is one step closer to going on the U.S. market.
MEDIVIS: Wins FDA Clearance for Breakthrough Augmented Reality Surgical System
SurgicalAR™ Officially Brings Holographic Visualization into the Operating Room
NUTEK FOOD SCIENCE: To Transition Potassium Salt Labeling Initiative to New FDA Docket
NuTek Food Science, LLC, a company that helps create great-tasting and affordable foods to enhance global health and wellness, announced that it is withdrawing its widely supported and highly publicized citizen petition concerning potassium salt that was filed with the FDA in 2016.
U.S. FOOD AND DRUG ADMINISTRATION: Statement on FDA’s request for information on requiring fixed-quantity blister packaging for certain opioid pain medicines to help decrease unnecessary exposure to opioids
The opioid tragedy has become one of the defining public health crises of modern times.
INOVA DIAGNOSTICS: QUANTA Flash RF IgM and IgA receive FDA clearance
Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is pleased to announce the 510(k) clearance of QUANTA Flash® Rheumatoid Factor (RF) IgM and QUANTA Flash RF IgA assays by the US Food and Drug Administration (FDA).
COTA, INC.: Signs Research Collaboration Agreement With The U.S. Food and Drug Administration
Collaboration Aims to Study Variation in Cancer Treatment Patterns by Extracting and Analyzing Real-World Data
NOVADOZ PHARMACEUTICALS: MSN Labs/Novadoz Pharmaceuticals receives consecutive FDA approvals for their generic versions of Solifenacin and Trientine
It was a very significant week for Novadoz Pharmaceuticals, the U.S sales & marketing affiliate of The MSN Group (MSN) based in Hyderabad, India.
SOLITON, INC.: Receives FDA 510(k) Clearance of its Acoustic Shockwave RAP Device
Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center ("MD Anderson"), announced that it has received clearance from the U.S. Food & Drug Administration ("FDA") to market its Rapid Acoustic Pulse ("RAP") device for tattoo removal.
CONTROLRAD, INC.: Announces FDA Clearance and Launch of the Only Radiation Reduction Technology that Integrates into Mobile C-arms
The ControlRad Trace solution reduces unnecessary radiation up to 89%, protecting patients and medical staff without compromising image quality or workflow.
OCTAPHARMA USA: FDA Approves New Octaplas™ Product Label
New Labeling Reports Results of Post-Marketing Study Demonstrating Safety, Efficacy and Tolerability in Pediatric Patients
REGENXBIO: Announces First FDA Approval of a Gene Therapy Based on Its Proprietary NAV® Technology Platform
FDA approval of Novartis' ZOLGENSMA for the treatment of pediatric patients with SMA marks the first regulatory approval based on REGENXBIO's NAV Technology
EPIBONE, INC.: Receives FDA Clearance to Commence its First-In-Human, Phase 1/2 Trial of its Bone Product, EB-CMF
Potential breakthrough technology for stem-cell based bone replacement
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THINK SURGICAL, INC.: Submits to the U.S. FDA for Clearance to Market its Active Robot for use in Total Knee Replacement Procedures
THINK Surgical, Inc. ("THINK") announces completion of enrollment for the U.S. investigational clinical study and submission of the 510(k) to obtain clearance from FDA to market its active robot, TSolution One®, for use in total knee replacement procedures.
U.S. FOOD AND DRUG ADMINISTRATION: Federal judge enters consent decree against compounder PharMedium Services for violations at multiple facilities
U.S. District Judge Virginia M. Kendall for the Northern District of Illinois entered a consent decree of permanent injunction between the United States and PharMedium Services, LLC, headquartered in Lake Forest, Ill., as well as Scott Aladeen, the company’s president, and Warren Horton, vice president for Quality and Research and Development.
U.S. FOOD AND DRUG ADMINISTRATION: Federal court enters consent decree against Texas compounder, Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions
U.S. District Judge Keith P. Ellison for the Southern District of Texas signed and entered a consent decree of permanent injunction, ordering a Texas-based company and its owners to stop producing compounded drugs intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements.
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MEDICAL MARIJUANA, INC.: CEO Chosen to Present Oral Comments at FDA's Public Hearing on Products Containing Cannabis and Cannabis-Derived Compounds
Medical Marijuana, Inc. (OTC: MJNA), the first publicly traded cannabis company in the United States, announced today that the Company's CEO, Dr. Stuart Titus, has been chosen as one of 65 speakers to present oral comments at the U.S. Food & Drug Administration (FDA)'s upcoming public hearing discussing scientific data and information about products containing cannabis-derived compounds.
PERRIGO COMPANY PLC: Announces FDA Final Approval For AB Rated Generic Version Of Voltaren® Gel 1%
Perrigo Company plc (NYSE; TASE: PRGO) announced its partner received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application (ANDA) referencing Voltaren® Gel, 1% (diclofenac sodium topical gel, 1%).