Vanda Pharmaceuticals Inc.: Vanda's Letter to FDA Commissioner Highlights Faulty Gastroparesis NDA Review
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) letter to FDA Commissioner highlights faulty gastroparesis NDA review. As ...
Hospitals must develop new protocols as overdose crisis enters dangerous new phase with ‘rhino tranq’
To address this evolving crisis, we must dramatically expand rapid access to treatments for addiction and harm reduction ...
Pharmabiz1h
US FDA clears Solid Biosciences’ IND application for SGT-212 to treat neurologic & cardiac manifestations of Friedreich’s ataxia
Charlestown, Massachusetts Thursday, January 9, 2025, 14:30 Hrs [IST] ...
FDA Accepts Astellas Pharma's Revised SNDA For IZERVAY In Geographic Atrophy Treatment
Astellas Pharma Inc. (ALPMY, ALPMY) announced that the U.S. Food and Drug Administration accepted the revised supplemental New Drug ...
AMD invests $20M in AI-powered drug discovery company Absci
Absci will use AMD’s $20 million investment to enhance its AI models. In parallel, the companies will collaborate to develop ...
Vanda asserts FDA review of tradipitant was flawed
Vanda (VNDA) has written a letter to FDA Commissioner Robert Califf asserting that the review of the market application for ...
Hosted on MSN13h
FDA Clears PCRX's New Iovera Smart Tip for Expanded Use in Pain Relief
Pacira BioSciences PCRX announced that the FDA has cleared its application to market a new Smart Tip for the iovera system ...
JD Supra15h
Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...
Targeted Oncology15h
FDA Clears Investigational New Drug Application for REC-4539 in SCLC
The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small ...
News Medical17h
University of Exeter launches new round of funding for fungal AMR solutions
A University of Exeter funding scheme designed to combat the global challenge of fungal antimicrobial resistance (fAMR) has announced a new call for applications.
FDA To Decide On Agios' Request For Expanded Approval Of PYRUKYND In Thalassemia By September 7.
Agios Pharmaceuticals, Inc. (AGIO), on Wednesday, announced that its supplemental New Drug Application seeking approval for the ...
Healio21h
FDA grants priority review to oral non-small cell lung cancer drug
The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain patients with ...