FDA approves BUPRENORPHINE HYDROCHLORIDE from ASCENT PHARMS INC FDA Approval Dec. 31, 2025, 13:45 UTC 32 0 comments Final approval of ANDA #ANDA #219401 for BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/18/2025 Comment Full text
FDA approves TENOFOVIR DISOPROXIL FUMARATE from MICRO LABS FDA Approval Dec. 31, 2025, 13:45 UTC 32 0 comments Final approval of ANDA #ANDA #206157 for TENOFOVIR DISOPROXIL FUMARATE. Decision date: 12/18/2025 Comment Full text
FDA approves RYBREVANT FASPRO from JANSSEN BIOTECH FDA Approval Dec. 31, 2025, 13:45 UTC 35 0 comments Final approval of BLA #BLA #761433 for AMIVANTAMAB AND HYALURONIDASE-LPUJ. Decision date: 12/17/2025 Comment Full text
FDA grants tentative approval for DAPAGLIFLOZIN from TEVA PHARMS USA INC FDA Approval Dec. 31, 2025, 13:45 UTC 33 0 comments Tentative approval of ANDA #ANDA #211541 for DAPAGLIFLOZIN. Decision date: 12/18/2025 Comment Full text
FDA expands indications for VRAYLAR FDA Approval Dec. 31, 2025, 13:45 UTC 37 0 comments ABBVIE receives approval for new indications. Submission: SUPPL-14. Decision date: 12/18/2025 Comment Full text
FDA approves VYBRIQUE from IBSA FDA Approval Dec. 31, 2025, 13:45 UTC 27 0 comments Final approval of NDA #NDA #210858 for SILDENAFIL CITRATE. Decision date: 12/16/2025 Comment Full text
FDA approves HYDROXYZINE HYDROCHLORIDE from NOVITIUM PHARMA FDA Approval Dec. 31, 2025, 13:45 UTC 22 0 comments Final approval of ANDA #ANDA #219648 for HYDROXYZINE HYDROCHLORIDE. Decision date: 12/16/2025 Comment Full text
FDA regulatory update for ZYNYZ FDA Approval Dec. 31, 2025, 13:45 UTC 16 0 comments Administrative update #SUPPL-5 for INCYTE CORP. Status: Approval. Decision date: 12/17/2025 Comment Full text
FDA approves EXDENSUR from GLAXOSMITHKLINE LLC FDA Approval Dec. 31, 2025, 13:45 UTC 30 0 comments Final approval of BLA #BLA #761458 for DEPEMOKIMAB-ULAA. Decision date: 12/16/2025 Comment Full text
FDA approves NILOTINIB from TORRENT FDA Approval Dec. 31, 2025, 13:45 UTC 28 0 comments Final approval of ANDA #ANDA #218532 for NILOTINIB. Decision date: 12/15/2025 Comment Full text