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).
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.
Food & Drug Administration Sets Prescription Drug User Fee Action Date for March 15, 2020
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 achieves unprecedented validation of Advisor Pro, its AI-based insulin recommendations technology
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 Continues to Expand Investigational Supply to Support International Ebola Outbreak Response
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.
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 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, 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 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.
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.
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.
The U.S. Food and Drug Administration today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise.
Reneo Pharmaceuticals, a clinical stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to the company's lead drug candidate, REN001, for the treatment of fatty acid oxidation disorders (FAOD).
A treatment for peanut allergies took another step toward becoming a reality as the Allergenic Products Committee voted to advise the U.S. Food and Drug Administration (FDA) this month during the approval process.
Over the past few years we’ve witnessed new medical breakthroughs that are altering how diseases are treated in ways that seemed unimaginable just a decade ago.
At the U.S. Food and Drug Administration we are committed to keeping patients, their families and caregivers at the center of our work and to deepening their involvement in how we review medical device applications.
British American Tobacco CEO Kingsley Wheaton recently released a statement addressing the U.S. Food and Drug Administration’s work to prevent minors from vaping.