NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF) announced that the company's candidate drug NeuroSTAT, in development for treatment of moderate to severe traumatic brain injury, TBI, has received Fast Track designation from the US Food and Drug Administration, FDA, facilitating its clinical development and path forwards to market.
Solio (https://www.soliotherapy.com/) recently announced the release of its innovative Alfa Plus, after receiving FDA clearance.
Two Republican senators recently introduced a bill they claim would combat U.S. drug shortages and drive down the prices of drugs and medical devices by allowing patients to select treatments approved in other countries.
Interventional Nephrologist Neghae Mawla, MD, pioneers minimally invasive fistula creation in Texas
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced that the University of Delaware, on behalf of NIIMBL, has entered into a Collaborative Research and Development Agreement (CRADA) with the Food and Drug Administration (FDA).
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
