Rejection
FDA Issues Complete Response Letter for Zealand Pharma’s Glepaglutide in Short Bowel Syndrome Treatment
Zealand Pharma, Glepaglutide, GLP-2 analog, Short Bowel Syndrome (SBS), FDA rejection, Complete Response Letter
FDA Rejects Subcutaneous Version of J&J’s Lung Cancer Drug Rybrevant Due to Manufacturing Concerns
FDA rejection, J&J, Subcutaneous Rybrevant, Manufacturing issues, Lung cancer drug, Non-small cell lung cancer (NSCLC), Epidermal growth factor receptor (EGFR) mutations
FDA Rejects Applied Therapeutics’ Rare Disease Drug Govorestat, Citing Clinical Application Deficiencies
Applied Therapeutics, FDA rejection, govorestat, galactosemia, rare metabolic disease, clinical application deficiencies
FDA Rejects Govorestat for Classic Galactosemia, Citing Clinical Deficiencies
FDA rejection, govorestat, classic galactosemia, Applied Therapeutics, rare disease drug approval, clinical deficiencies
Vanda Pharmaceuticals Rejects Cycle’s Second Takeover Bid Amid FDA Rejection of Tradipitant
Vanda Pharmaceuticals, Cycle Pharmaceuticals, takeover bid, FDA rejection, tradipitant, gastroparesis, biopharma, acquisition offer