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Bardy Diagnostics, Inc., ("BardyDx"), a leading provider of ambulatory cardiac monitoring technologies and custom data solutions, announced today it received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for the 14-Day version of the Carnation Ambulatory Monitor ("CAM™"), the industry's only P-wave centric™ ambulatory cardiac patch monitor and arrhythmia detection device.
AVRA Medical Robotics, Inc. (the “Company”) (OTCQB: AVMR), an emerging growth company that is in the process of building a fully autonomous medical robotic system through the use of new technologies combining artificial intelligence, machine learning and proprietary software; announced that its regulatory and management teams met with the Food and Drug Administration (FDA) on August 12th.
Aesculap Implant Systems, LLC, a leader in lumbar motion preservation technology, today announced the e-publication of the "Five-year results of a randomized controlled trial for lumbar artificial discs in single level degenerative disc disease" in Spine
As prescription drugs remain inaccessible to most, the notion of patent reform is seemingly settling into public discourse.
Some in Congress are hoping the Republican sponsored Fair Care Act of 2019 will open the floodgates for Americans to buy health insurance.
Concept Medical Inc. (CMI) has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA) for MagicTouch PTA (Percutaneous Transluminal Angioplasty), its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK). The first 'Breakthrough Device Designation' received by Concept Medical Inc. was on 30th April 2019 for its MagicTouch SCB, for the treatment of Coronary Artery Disease (CAD) in patients with in-stent restenosis.
Targeting Topline Data from STRIDE 3 by the End of 2019
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.
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
Thermo Scientific Medical Device portfolio provides an extensive range of chromatography and mass spectrometry instruments for performing laboratory developed tests
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.
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).
Immix receives FDA letter activating the IND for IMX-110
The U.S. Food and Drug Administration is using some new tools in its drug approval process and at least one prominent industry leader is giving the government entity a thumb’s up.
User Fee Goal Date is December 27, 2019
Center for Veterinary Medicine to apply GastroPlus® to assess product bioequivalence in canines
Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that its collaborator Janssen Biotech, Inc. (Janssen) has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for the subcutaneous delivery of DARZALEX® (daratumumab) for patients with multiple myeloma.