FDA regulatory update for ENHERTU FDA Approval Dec. 31, 2025, 13:45 UTC 6 0 comments Administrative update #SUPPL-38 for DAIICHI SANKYO. Status: Approval. Decision date: 12/15/2025 Comment Full text
FDA approves TENOFOVIR DISOPROXIL FUMARATE from MICRO LABS FDA Approval Dec. 31, 2025, 13:45 UTC 1 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 4 0 comments Final approval of BLA #BLA #761433 for AMIVANTAMAB AND HYALURONIDASE-LPUJ. Decision date: 12/17/2025 Comment Full text
FDA approves BUPRENORPHINE HYDROCHLORIDE from ASCENT PHARMS INC FDA Approval Dec. 31, 2025, 13:45 UTC 8 0 comments Final approval of ANDA #ANDA #219401 for BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/18/2025 Comment Full text
FDA expands indications for VRAYLAR FDA Approval Dec. 31, 2025, 13:45 UTC 5 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 3 0 comments Final approval of NDA #NDA #210858 for SILDENAFIL CITRATE. Decision date: 12/16/2025 Comment Full text
FDA approves NILOTINIB from TORRENT FDA Approval Dec. 31, 2025, 13:45 UTC 2 0 comments Final approval of ANDA #ANDA #218532 for NILOTINIB. Decision date: 12/15/2025 Comment Full text
FDA updates labeling for ACETAMINOPHEN AND IBUPROFEN FDA Approval Dec. 31, 2025, 13:45 UTC 1 0 comments Labeling changes approved for GRANULES. Active ingredient: ACETAMINOPHEN; IBUPROFEN. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for CIPROFLOXACIN HYDROCHLORIDE FDA Approval Dec. 31, 2025, 13:45 UTC 6 0 comments Labeling changes approved for UNIQUE. Active ingredient: CIPROFLOXACIN HYDROCHLORIDE. Decision date: 12/17/2025 Comment Full text
FDA approves LATANOPROST from MANKIND PHARMA FDA Approval Dec. 31, 2025, 13:45 UTC 2 0 comments Final approval of ANDA #ANDA #220360 for LATANOPROST. Decision date: 12/17/2025 Comment Full text