Food and Drug Administration (FDA)
NEWS
The FDA’s Cardiovascular and Renal Drugs Advisory Committee stood against Cytokinetics, Inc., finding that the benefits of its heart failure hopeful didn’t outweigh its risks.
The FDA has a number of PDUFA dates for the remainder of November for Spectrum, ImmunoGen, Scynexis and Y-mAbs.
The FDA has approved Provention’s BLA for intravenous antibody TZIELD to delay stage 3 type 1 diabetes, making it the first disease-modifying drug indicated to slow disease progression.
The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted against the potential Emergency Use Authorization of the company’s COVID-19 therapeutic candidate, sabizabulin.
The FDA is gearing up for deadlines and PDUFA dates in mid-November with Seagen, Provention, Clarus and Tolmar, and Ligand and Travere.
Minneapolis-based DiaMedica Therapeutics plans to conduct additional studies in order to resolve a clinical hold on its DM199 program for the treatment of acute ischemic stroke (AIS).
The FDA released guidelines Thursday in an attempt to clarify processes for assessing a drug candidate’s efficacy while examining several endpoints, simultaneously.
Shares of Massachusetts-based Minerva Neurosciences dropped Monday after the FDA issued a Refuse to File letter for the company’s schizophrenia drug, roluperidone.
The FDA has numerous activities and interactions with Phanes, Prestige Biopharma, Reata, Pfizer and more, providing clearance, approving clinical trials and other regulatory actions.
JOBS
IN THE PRESS