September, 2019 Stories | FDA Health News

By FDA Health News Reports | Sep 12, 2019

The U.S. Food and Drug Administration inspects numerous facilities around the nation to ensure that they comply with current rules governing FDA-regulated products.

FDA issues warning about three Hepatitis C medications

By Amanda Smith-Teutsch | Sep 12, 2019

The FDA is warning that certain Hepatitis C treatments can cause further damage to the livers of people with advanced cases of liver disease.

Sandoz Inc. recalls Losartan Potassium, Ezetimibe

By Amanda Smith-Teutsch | Sep 12, 2019

Sandoz Inc. is recalling two medications that treat cholesterol and high blood pressure because the bottles they were packaged in failed to meet child-resistant closure requirements.

FDA confirms guidance on placebos, blinding for cancer trials

By John Severance | Sep 12, 2019

The Food and Drug Administration (FDA) made a recommendation to drugmakers last week stating that they only use placebos in cancer clinical trials in select circumstances.

XERIS PHARMACEUTICALS: Receives U.S. FDA Approval for GVOKE™ (glucagon), the First Ready-to-use Stable Liquid Glucagon for Severe Hypoglycemia

By Press release submission | Sep 13, 2019

First approval for Xeris is based on positive efficacy and safety results from multiple clinical studies

ACCELERON PHARMA: Receives FDA Orphan Drug Designation for Sotatercept in Pulmonary Arterial Hypertension

By Press release submission | Sep 13, 2019

Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug designation to sotatercept for the treatment of patients with pulmonary arterial hypertension (PAH).

&&& Science group calls FDA fast-track approval of nasal spray shocking

By Angela Underwood | Sep 13, 2019

The Center for Responsible Science (CRS) said it is shocking that the Federal Drug Administration (FDA) granted fast-track approval for a nasal spary based on a two-day study of 30 trial participants because it was fast-acting and later declined to label the drug fast-acting on approval.

ASTELLAS PHARMA INC.: Seattle Genetics and Astellas Announce U.S. FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer

By Press release submission | Sep 16, 2019

Food & Drug Administration Sets Prescription Drug User Fee Action Date for March 15, 2020

JANSSEN: Submits Application to U.S. FDA Seeking First-in-Class Approval of TREMFYA® (guselkumab) for Treatment of Adults with Active Psoriatic Arthritis

By Press release submission | Sep 16, 2019

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking first-in-class approval of TREMFYA® (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA).

DREAMED DIABETES: New FDA Clearance Paves The Way to Optimization of Insulin Pump Therapy Across All Glucose Measurement Methods

By Press release submission | Sep 17, 2019

DreaMed Diabetes achieves unprecedented validation of Advisor Pro, its AI-based insulin recommendations technology

GALA THERAPEUTICS: Receives FDA Breakthrough Device Designation for the Minimally Invasive RheOx™ System for Chronic Bronchitis

By Press release submission | Sep 17, 2019

Gala Therapeutics, Inc. (Gala), a developer of medical devices to treat pulmonary disease, announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation (FDA) for the RheOxTM Bronchial RheoplastyTM system.

MERCK: FDA Accepts Merck’s Biologics License Application (BLA) and Grants Priority Review for V920, the Company’s Investigational Vaccine for Ebola Zaire Virus

By Press release submission | Sep 18, 2019

Merck Continues to Expand Investigational Supply to Support International Ebola Outbreak Response

PERSPECTUM DIAGNOSTICS: Announces FDA Grant Award for LiverMultiScan to Help NASH Patients

By Press release submission | Sep 18, 2019

The Food and Drug Administration (FDA) has awarded Perspectum Inc $250,000 to qualify its proprietary biomarkers for NASH in collaboration with Dr. Naim Alkhouri at the Texas Liver Institute.

FDA approves treatment for rare lung disease scleroderma

By John Severance | Sep 18, 2019

The treatment involves taking Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, which is called SSc-ILD.

SOUND PHARMACEUTICALS: FDA grants Fast Track Designation for SPI-1005 in the Treatment of Meniere's Disease

By Press release submission | Sep 19, 2019

Sound Pharmaceuticals is pleased to announce that the FDA's Division of Neurology Products has granted its request for Fast Track Designation (FTD) involving SPI-1005 in the treatment of Meniere's Disease (MD).

ELYSIUM HEALTH: Announces FDA Acceptance of Investigational New Drug Application to Evaluate BASIS™ for Prevention of Acute Kidney Injury in Surgical Cardiac Patients

By Press release submission | Sep 19, 2019

Elysium Health, Inc.,™ a life sciences company developing clinically validated health products based on aging research, today announced the acceptance of an Investigational New Drug ("IND") application by the Food and Drug Administration (FDA) to evaluate the efficacy of BASIS™ for the prevention of acute kidney injury (AKI) in surgical cardiac patients.

Omega passes FDA's initial Establishment Inspection Report

By Keri Carbaugh | Sep 19, 2019

Omega Laboratories Limited, a Canadian-based subsidiary of Nichi-Iko Pharmaceutical Co., Ltd., and Sagent Pharmaceuticals, Inc., recently passed its initial Food and Drug Administration (FDA) Establishment Inspection Report and will now be allowed to manufacture FDA-approved products.

Lilly accepted to FDA’s Complex Innovative Trial Designs Pilot Meeting Program

By Keri Carbaugh | Sep 19, 2019

Eli Lilly and Co. was recently accepted into the U.S. Food and Drug Administration’s (FDA) Complex Innovative Trial Designs (CID) Pilot Meeting Program.

FDA Update: August inspection citations