Mesa Biotech Inc. is a privately-held, molecular diagnostic company that has developed the Accula™ System, an affordable, sample-to-answer, CLIA-waived PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis
KEYTRUDA Now Approved for Recurrent Locally Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus in Patients Whose Tumors Express PD-L1 (CPS ≥10) With Disease Progression After One or More Prior Lines of Systemic Therapy
People afflicted with the deadly and crushing disease amyotrophic lateral sclerosis (ALS) are searching for some glimmer of hope in the shadow of promising drug treatments, however ALS patients do not currently have real access to these drugs, which are presently in trials.
A December 2018 decision by the Food and Drug Administration (FDA) to block the final approval of a product from Braeburn Pharmaceuticals for the treatment of opioid use disorder has been vacated.
The Food and Drug Administration (FDA) recently released guidelines for safety reporting for combination products that clarify which companies and products must abide by the final rules on post-marketing safety reporting (PMSR) requirements and how exactly to do so.
The MEDICREA® Group (Euronext Growth Paris: FR0004178572 – ALMED ; OTCQX Best Market – MRNTF), pioneering the digital transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD™ ASI (Adaptive Spine Intelligence) proprietary software platform, services and technologies, announced today that it has received FDA-Clearance for TULIP GENESIS™ which completes its UNiD™ ASI platform technology.
FDA 510(k) cleared Respiration Rate analytic adds to physIQ’s growing portfolio of FDA 510(k) algorithms
The U.S. Food and Drug Administration issued 14 warning letters in July that were sent to manufacturers and other companies found to have violated FDA regulations.
FDA statement on court ruling related to compounded bulk drug substances
Inotrem S.A., a biotechnology company specialized in immunotherapy for acute inflammatory syndromes, announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for the ASTONISH trial (Phase IIb) where the safety, tolerance and efficacy of nangibotide (LR12), its lead compound for septic shock, will be studied.
Dalent Medical, a Miami-based company developing innovative devices for Ear, Nose & Throat Doctors is pleased to announce that the Sinusleeve™ Balloon Sinus Dilation Sleeve has completed the United States Food and Drug Administration's listing process.
Thermo Scientific Medical Device portfolio provides an extensive range of chromatography and mass spectrometry instruments for performing laboratory developed tests
The collaborative project between the organizations will kick off at a launch meeting in September and will aim to reduce barriers for the development of new treatments and cures for rare diseases
Adherence to FDA Quality Standards Will Boost Ability of Fabrication Facility to Produce Pilot-Scale Devices for NextFlex Members and Customers
Gilead Sciences, Inc. (NASDAQ: GILD) announced that the Antimicrobial Drugs Advisory Committee (AMDAC) of the U.S. Food and Drug Administration (FDA) recommended approval of Descovy®(emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) for the proposed indication of pre-exposure prophylaxis (PrEP) in men and transgender women (TGW) who have sex with men by a vote of 16 to 2.
Mammograms per year in the nation numbered more than 39.5 million as of Aug. 1, the U.S. Food and Drug Administration reports.
Targeting Topline Data from STRIDE 3 by the End of 2019
.jpg){kind=tracking}
Perfuze is developing novel catheter-based technology for treating acute ischemic stroke
Leading authorities on hemp are set to gather next week in Portland, Oregon, in anticipation of learning more about upcoming regulations to the industry.
