The innovative micro-endoscope with multiple working channels is single use, eliminating the risk of transmitting infections among patients.
.jpg){kind=tracking}
United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplement to the New Drug Application for Orenitram® (treprostinil) Extended-Release Tablets reflecting data from the FREEDOM-EV study in patients with pulmonary arterial hypertension (PAH).
Application Seeks to Extend Duration of Use Up to Six Years for Mirena
Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and Drug Administration (FDA) has approved Heron's supplemental New Drug Application (sNDA) for CINVANTI (aprepitant) injectable emulsion for intravenous (IV) use. The sNDA requested FDA approval to expand the recommended dosage to include the 130 mg single-dose regimen for patients receiving MEC.
Legal teams pursuing numerous lawsuits against Johnson & Johnson on behalf of ovarian cancer victims alleging that asbestos in the manufacturer's baby powder made them sick are saying that J&J's announcement Friday of a voluntary recall of the product should help prove their claims.
For nearly 20 years, regenerative medicine such as cell and gene therapies have gradually shown much promise in repairing or replacing damaged and infected cells, tissues and organs in order to cure ailments including organ failure, spinal cord injuries, multiple sclerosis and other traumatic wounds and diseases.
Garwood Medical Devices, a company focused on advancing infection control through innovation, announces today that it has been granted Breakthrough Device designation by the Food and Drug Administration (FDA) for its BioPrax™ device.
FDA is also working quickly to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD
A new report on the U.S. Food and Drug Administration's (FDA) generic drug program highlights the agency's all-time record number of approvals for fiscal year 2018.
FDA recommends including a boxed warning and other elements in breast implant labeling
A research team from the School of Chinese Medicine at Hong Kong Baptist University (HKBU) has successfully developed a novel aptamer, i.e. a single-stranded piece of DNA, for the treatment of osteogenesis imperfecta (OI) with the aid of artificial intelligence (AI) technology. It is the first time a drug in Hong Kong has been granted orphan drug designation by the US Food and Drug Administration (FDA).
Surface Modifying Macromolecules in Dialyzers and Bloodlines are Paired with Dialysate Formula to Prevent Clots
Flowonix Medical, Inc.announced approval from the United States Food and Drug Administration (FDA) to market the Prometra II® 40 mL Programmable Pump and its associated programmer software.
.jpg){kind=tracking}
The U.S. Food and Drug Administration (FDA) recognizes that consumers may use various types of unapproved drugs, such as homeopathic drug products, to treat or relieve different diseases and conditions.
ARsgen Therapeutics Co. Ltd., a clinical-stage biopharmaceutical company today announced that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational CT053 CAR-T cell therapy. CT053 is a fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cell therapy for the treatment of relapsed and/or refractory multiple myeloma (rrMM).
SFA Therapeutics, Inc. announced today that FDA has granted an official Orphan Drug Designation (ODD) to SFA001, the company's novel human-microbiome-based treatment for human hepatocellular carcinoma (HCC).
Given proximity of NDA action date to anticipated top-line data readout for Phase 3 VOYAGER trial, FDA requested VOYAGER top-line data to inform its review of fourth-line GIST indicatio
Suntiva, a trusted advisor to leaders in achieving critical business transformation outcomes, is proud to announce that it recently won ten BPA orders with the U.S. Food and Drug Administration (FDA), with a total value of more than $9 million.
Acting commissioner of the U.S. Food and Drug Administration (FDA) Dr. Ned Sharpless recently released a statement regarding medical device availability following the closure of multiple sterilization facilities.
The U.S. Food and Drug Administration's (FDA) acting commissioner, Dr. Ned Sharpless, has released a statement on the agency’s efforts to address the opioid crisis as the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act marked its one year anniversary on Oct. 24.