July, 2020 Stories | FDA Health News

Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, announced it received approval from the U.S. Food and Drug Administration (FDA) for the KONECT RESILIA aortic valved conduit (AVC), the first ready-to-implant solution for bio-Bentall procedures, a complex surgery that involves replacement of a patient's aortic valve, aortic root and the ascending aorta.

DENOVO BIOPHARMA LLC: FDA Grants Fast Track Designation For DB102 in Patients with Newly-Diagnosed Glioblastoma (GBM)

Fast Track Designation Highlights the Urgent Need for New Treatment Options

INFLAZOME: FDA Grants Orphan Drug Designation for Inflazome’s Inzomelid for the Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)

Inzomelid is a potent, selective, orally-available, brain-penetrant NLRP3 inflammasome inhibitor intended for treatment of debilitating inflammatory diseases

CELYAD ONCOLOGY: Announces FDA Clearance of IND Application for CYAD-211, First shRNA-based, Non-Gene Edited Allogeneic CAR T Therapy

Phase 1 clinical trial evaluating the off-the-shelf anti-BCMA CAR T candidate CYAD-211 for the treatment of relapsed/refractory multiple myeloma (r/r MM) expected to begin by year-end 2020

ALCON: Announces FDA Approval of the OTC Switch of Pataday Once Daily Relief Extra Strength

Pataday® Once Daily Relief Extra Strength (olopatadine 0.7%) is the first and only eye allergy itch drop offering a full 24 hours of relief without a prescription in the U.S.1

GALT: Opioid-free Pain Med Orphengesic Forte by Galt Pharmaceuticals Approved by FDA

By Press release submission | Jul 18, 2020

Pharmaceutical innovator Galt Pharmaceuticals announced a new drug approval to offer a non-opioid, non-controlled, non-addictive alternative for healthcare providers to manage patients suffering from pain.

MERCK: FDA Grants Priority Review to Merck’s New Drug Application for Vericiguat

By Press release submission | Jul 18, 2020

Application Based on First Contemporary Outcomes Study Focused Exclusively on Chronic Heart Failure Patient Population Following a Worsening Event

FDA: Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products

Drug Shortages

The U.S. Food and Drug Administration is extending the enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps).

TCI BIO: TCI GENE, registered with US FDA, aims to support accurate testing in international airports

Reform

TCI GENE, a subsidiary of TCI Co., Ltd. (Ticker: 8436) that produces the MOHW-certified QVS-96 system delivered to Kunyang Laboratory, CDC, Taiwan, has been registered with U.S. FDA and qualified to sell the fully automated detection integration system in the U.S. With the high influence of the US FDA in the world, it is believed that FDA in many countries will refer to its standard for the certification of the system, and it is expected that the system will be installed in major airports around the world to support epidemic prevention and help restore high traffic for economic recovery.

AMPIO: Reports a Publication on the Potential Benefits of Ampion for Treatment of a New COVID-19 related Syndrome

Reform

Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the development and advancement of immunology based therapies for prevalent inflammatory conditions, today announced the publication "Insights into pediatric multi-system inflammatory syndrome and COVID-19."

KERANETICS: Announces KeraStat® Cream product cleared by FDA for radiation dermatitis

KeraNetics Inc. announces today that the next product in its KeraStat® wound dressing portfolio, KeraStat® Cream, has been cleared by the US Food and Drug Administration for indications of radiation dermatitis.

CHANNEL MEDSYSTEMS: Receives FDA Approval of its Latest Cerene® Cryotherapy Device for the Treatment of Heavy Menstrual Bleeding in the Office Setting

By Press release submission | Jul 22, 2020

Next-generation technology enhances ease-of-use for physicians and streamlines manufacturability

LIFESIGNALS: Wireless Medical Biosensor LP1250 receives FDA clearance

By Press release submission | Jul 22, 2020

World's first single-use two channel ECG and heart rate biosensor provides 72-hour patient monitoring with remote data access in ambulatory, hospital and home settings

FDA: Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed or Refractory MCL

By Press release submission | Jul 25, 2020

The U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment.

FDA: Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection

By Press release submission | Jul 25, 2020

Authorization is also second to allow testing of pooled samples

KITE: U.S. FDA Approves Kite’s Tecartus™, the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma

By Press release submission | Jul 26, 2020

87 Percent of Patients in ZUMA-2 Pivotal Trial Responded to Single Infusion of Tecartus

VITA THERAPEUTICS: Receives Orphan Drug Designation from FDA for new novel treatment

By Press release submission | Jul 26, 2020

Vita Therapeutics, Inc. announced that it received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for VTA-110, a novel regenerative therapy for the treatment of Duchenne's Muscular Dystrophy (DMD).

HEMOSHEAR THERAPEUTICS: Receives FDA Fast Track and Rare Pediatric Disease Designations for HST5040 to Treat Methylmalonic Acidemia and Propionic Acidemia

By Press release submission | Jul 30, 2020

Designations Highlight the Urgent Need for Treatments for These Rare Diseases

ANIXA BIOSCIENCES: Breast Cancer Vaccine Technology Nearing FDA Submission