FDA updates labeling for VIVITROL FDA Approval Dec. 23, 2025, 09:48 UTC 22 0 comments Labeling changes approved for ALKERMES. Active ingredient: NALTREXONE. Decision date: 12/22/2025 Comment Full text
FDA approves TENOFOVIR DISOPROXIL FUMARATE from MICRO LABS FDA Approval Dec. 23, 2025, 09:48 UTC 20 0 comments Final approval of ANDA #ANDA #206157 for TENOFOVIR DISOPROXIL FUMARATE. Decision date: 12/18/2025 Comment Full text
FDA approves manufacturing change for NISOLDIPINE FDA Approval Dec. 23, 2025, 09:48 UTC 23 0 comments Manufacturing process update for AMTA. Submission: SUPPL-2. Decision date: 12/12/2025 Comment Full text
FDA approves MYQORZO from CYTOKINETICS INC FDA Approval Dec. 22, 2025, 20:14 UTC 37 0 comments Final approval of NDA #NDA #219083 for AFICAMTEN. Decision date: 12/19/2025 Comment Full text
FDA approves NUFYMCO from FORMYCON AG FDA Approval Dec. 19, 2025, 19:45 UTC 55 0 comments Final approval of BLA #BLA #761473 for RANIBIZUMAB-LEYK. Decision date: 12/18/2025 Comment Full text
FDA approves JASCAYD from BOEHRINGER INGELHEIM PHARMACEUTICALS INC FDA Approval Dec. 19, 2025, 19:02 UTC 32 0 comments Final approval of NDA #NDA #220449 for NERANDOMILAST. Decision date: 12/19/2025 Comment Full text
FDA approves RYBREVANT FASPRO from JANSSEN BIOTECH FDA Approval Dec. 19, 2025, 16:00 UTC 37 0 comments Final approval of BLA #BLA #761433 for AMIVANTAMAB AND HYALURONIDASE-LPUJ. Decision date: 12/17/2025 Comment Full text
FDA updates labeling for CLOMIPHENE CITRATE FDA Approval Dec. 19, 2025, 09:57 UTC 31 0 comments Labeling changes approved for COSETTE. Active ingredient: CLOMIPHENE CITRATE. Decision date: 12/18/2025 Comment Full text
FDA approves NOREPINEPHRINE BITARTRATE from MSN FDA Approval Dec. 19, 2025, 09:57 UTC 29 0 comments Final approval of ANDA #ANDA #218595 for NOREPINEPHRINE BITARTRATE. Decision date: 12/11/2025 Comment Full text
FDA approves ACETAMINOPHEN AND IBUPROFEN from LNK INTL INC FDA Approval Dec. 19, 2025, 09:57 UTC 33 0 comments Final approval of ANDA #ANDA #220126 for ACETAMINOPHEN; IBUPROFEN. Decision date: 12/11/2025 Comment Full text