FDA approves GLYCOPYRROLATE from BIONPHARMA FDA Approval Dec. 31, 2025, 13:45 UTC 6 0 comments Final approval of ANDA #ANDA #220062 for GLYCOPYRROLATE. Decision date: 12/23/2025 Comment Full text
FDA approves METHYLENE BLUE from CHENGDU SHUODE FDA Approval Dec. 31, 2025, 13:45 UTC 6 0 comments Final approval of ANDA #ANDA #219550 for METHYLENE BLUE. Decision date: 12/23/2025 Comment Full text
FDA regulatory update for CABLIVI FDA Approval Dec. 31, 2025, 13:45 UTC 10 0 comments Administrative update #SUPPL-18 for ABLYNX NV. Status: Approval. Decision date: 12/23/2025 Comment Full text
FDA grants tentative approval for DAPAGLIFLOZIN from JIANGSU HANSOH PHARM FDA Approval Dec. 31, 2025, 13:45 UTC 3 0 comments Tentative approval of ANDA #ANDA #216119 for DAPAGLIFLOZIN. Decision date: 12/23/2025 Comment Full text
FDA grants tentative approval for NINTEDANIB from GLENMARK PHARMS LTD FDA Approval Dec. 31, 2025, 13:45 UTC 7 0 comments Tentative approval of ANDA #ANDA #212555 for NINTEDANIB ESYLATE. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for YONDELIS FDA Approval Dec. 31, 2025, 13:45 UTC 7 0 comments Labeling changes approved for JANSSEN PRODS. Active ingredient: TRABECTEDIN. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for ORLYNVAH FDA Approval Dec. 31, 2025, 13:45 UTC 1 0 comments Labeling changes approved for ITERUM THERAP. Active ingredient: PROBENECID; SULOPENEM ETZADROXIL. Decision date: 12/23/2025 Comment Full text
FDA expands indications for PYRUKYND FDA Approval Dec. 31, 2025, 13:45 UTC 6 0 comments AGIOS PHARMS INC receives approval for new indications. Submission: SUPPL-3. Decision date: 12/23/2025 Comment Full text
FDA updates labeling for ORLADEYO FDA Approval Dec. 31, 2025, 13:45 UTC 6 0 comments Labeling changes approved for BIOCRYST. Active ingredient: BEROTRALSTAT DIHYDROCHLORIDE. Decision date: 12/23/2025 Comment Full text
FDA regulatory update for IDACIO FDA Approval Dec. 31, 2025, 13:45 UTC 2 0 comments Administrative update #SUPPL-12 for FRESENIUS KABI USA. Status: Approval. Decision date: 12/23/2025 Comment Full text