Tuesday, November 12, 2019

Tuesday, November 12, 2019

Latest News

CARSGEN: Announces Investigational CAR-T Therapy CT053 Granted RMAT Designation by the U.S. FDA for R/R Multiple Myeloma

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).

U.S. FDA: Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Center for Drug Evaluation and Research Director Janet Woodcock, M.D., on the agency's efforts to protect patients from potentially harmful drugs sold as homeopathic products

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.

FLOWONIX MEDICAL: Receives FDA Approval for its Prometra II® 40 mL Programmable Pump System

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.

HKBU: HKBU Drug the First in Hong Kong to be Granted Orphan Drug Designation by the US FDA

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).

FDA approved record number of generic drugs in 2018

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.

GARWOOD MEDICAL DEVICES: FDA Grants Breakthrough Device Designation to BioPrax™ Biofilm Disruption Device

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.

Johnson & Johnson announces recall after FDA test confirms asbestos in batch of baby powder

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.

HERON THERAPEUTICS: Announces FDA Approval of Supplemental New Drug Application to Expand CINVANTI® Label for Single-Dose Regimen for Patients Receiving Moderately Emetogenic Chemotherapy (MEC)

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.

UNITED THERAPEUTICS: Announces FDA Approval Of Updated Label For Orenitram Reflecting Results Of FREEDOM-EV Study

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).

ENLIGHTENVUE: enlightenVue's Single Use Micro-Endoscope complies with new FDA recommendations to increase patient safety

The innovative micro-endoscope with multiple working channels is single use, eliminating the risk of transmitting infections among patients.

MICROPHYT: Microphyt’s PhaeoSOL Receives New Dietary Ingredient (NDI) Status from the FDA

PhaeoSOL is a natural microalgae-based nutritional ingredient aiming at improving the well-being of the elderly and preventing certain metabolic disorders


Fully Automated Technology from Ortho Clinical Diagnostics Aids in Extended Antigen Phenotyping and Ensures Delivery of Safe Blood to Transfusion Patients

SHIONOGI: U.S. FDA Advisory Committee Recommends Approval of Cefiderocol for Treatment of Complicated Urinary Tract Infections

Shionogi & Co., Ltd. (hereafter “Shionogi”) announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee voted to recommend approval of the investigational antibiotic cefiderocol for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in patients with limited or no alternative treatment options.

CARBOFIX: Extends Its CarboClear® Carbon Fiber Spinal Product Line With Its FDA Cleared Vertebral Body Replacement (VBR) System

The product to be officially launched during the Congress of Neurological Surgeons (CNS) in San Francisco, October 21-23, 2019

FIDMI MEDICAL: Receives FDA Regulatory Clearance for Low-profile Enteral Feeding Device

Fidmi Medical Ltd. a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T) (OTCQX: TRNLY), announced today that it received 510K regulatory clearance from the United States Food and Drug Administration (FDA) for its low-profile enteral feeding device.

MD Anderson's Hahn a frontrunner for FDA Commissioner

Stephen Hahn, M.D., Chief Medical Executive of The University of Texas MD Anderson Cancer Center, is the top candidate to be the next commissioner of the U.S. Food and Drug Administration (FDA).

FDA Reporter