Lilly accepted to FDA’s Complex Innovative Trial Designs Pilot Meeting Program
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.
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.
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.
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.
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).
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.
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.
Merck Continues to Expand Investigational Supply to Support International Ebola Outbreak Response
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.
DreaMed Diabetes achieves unprecedented validation of Advisor Pro, its AI-based insulin recommendations technology
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).
Food & Drug Administration Sets Prescription Drug User Fee Action Date for March 15, 2020
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.
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).
First approval for Xeris is based on positive efficacy and safety results from multiple clinical studies
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.
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.
The FDA is warning that certain Hepatitis C treatments can cause further damage to the livers of people with advanced cases of liver disease.
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.
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed therapy (third-line disease).
Omeros Remains On Track to Initiate the Submission Next Quarter