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FDA regulatory update for UPLIZNA

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 29
  • 0 comments

Administrative update #SUPPL-4 for VIELA BIO. Status: Approval. Decision date: 12/11/2025

Comment Full text

FDA approves CARDAMYST from MILESTONE PHARMS USA

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 26
  • 0 comments

Final approval of NDA #NDA #218571 for ETRIPAMIL. Decision date: 12/12/2025

Comment Full text

FDA grants tentative approval for DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE from AUROBINDO PHARMA LIMITED

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 35
  • 0 comments

Tentative approval of ANDA #ANDA #211489 for DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE. Decision date: 12/10/2025

Comment Full text

FDA regulatory update for ACTEMRA

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 30
  • 0 comments

Administrative update #SUPPL-59 for GENENTECH. Status: Approval. Decision date: 12/10/2025

Comment Full text

FDA updates labeling for HYDROCODONE BITARTRATE AND ACETAMINOPHEN

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 29
  • 0 comments

Labeling changes approved for ACTAVIS LABS FL INC. Active ingredient: ACETAMINOPHEN; HYDROCODONE BITARTRATE. Decision date: 12/11/2025

Comment Full text

FDA updates labeling for DEPO-SUBQ PROVERA 104

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 25
  • 0 comments

Labeling changes approved for PFIZER. Active ingredient: MEDROXYPROGESTERONE ACETATE. Decision date: 12/12/2025

Comment Full text

FDA expands indications for AKEEGA

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 31
  • 0 comments

JANSSEN BIOTECH receives approval for new indications. Submission: SUPPL-1. Decision date: 12/12/2025

Comment Full text

FDA approves LEROCHOL from LIB THERAPEUTICS, INC.

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 32
  • 0 comments

Final approval of BLA #BLA #761427 for LERODALCIBEP-LIGA. Decision date: 12/12/2025

Comment Full text

FDA updates labeling for ROMVIMZA

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 27
  • 0 comments

Labeling changes approved for DECIPHERA PHARMS. Active ingredient: VIMSELTINIB. Decision date: 12/12/2025

Comment Full text

FDA updates labeling for TRAMADOL HYDROCHLORIDE

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 30
  • 0 comments

Labeling changes approved for SUN PHARM. Active ingredient: TRAMADOL HYDROCHLORIDE. Decision date: 12/12/2025

Comment Full text
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