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FDA Expands Pembrolizumab Approval for Endometrial Cancer
Medscape· 5 days agoThe FDA expanded the approval of pembrolizumab based on improved PFS in patients with advanced or...
FDA approves Amgen’s BLINCYTO for acute lymphoblastic leukaemia
Pharmaceutical Technology via Yahoo Finance· 5 days agoThe US Food and Drug Administration (FDA) has approved Amgen’s BLINCYTO (blinatumomab) for...
FDA approves MSD’s KEYTRUDA for advanced endometrial cancer
Pharmaceutical Technology via Yahoo Finance· 4 days agoThe US Food and Drug Administration (FDA) has approved MSD’s anti-PD-1 therapy KEYTRUDA for use with...
FDA Grants Small Dispensers More Time, but Nobody Else | JD Supra
JD Supra· 3 days agoOn June 12, 2024, FDA granted small dispensers — defined as owners that have 25 or fewer full-time employees licensed as pharmacists or qualified pharmacy technicians, and ...
FDA Expands Orphan Drug Designation for SurVaxM, I | Newswise
Newswise· 2 days agoBUFFALO, N.Y. — The U.S. Food and Drug Administration (FDA) has expanded orphan drug designation for SurVaxM, a brain cancer immunotherapy born in the labs of Roswell Park ...
FDA halts trial of BioNTech-MediLink ADC over 'significant risk of illness'
FierceBiotech· 5 days agoThe FDA has slammed the brakes on a trial of MediLink Therapeutics’ BioNTech-partnered antibody-drug...
FDA approves Biotest’s plasma-derived treatment for immunodeficiencies
BioPharma-Reporter· 2 days agoYimmugo, an intravenous immunoglobulin therapeutic, is the first therapy developed by Biotest to be...
FDA issues warning to Dollar Tree over its failure to remove recalled children's snack
FOX Business· 3 days agoThe U.S. Food and Drug Administration (FDA) sent a warning letter to Dollar Tree, Inc. last week...
Pharma Stock Roundup: FDA Nod to MRK's New Jab & Expanded Use of ABBV & AZN Drugs
Zacks· 2 days agoFDA approves Merck's (MRK) 21-valent pneumococcal conjugate vaccine, Capvaxive and the expanded use of AbbVie's (ABBV) Skyrizi and AstraZeneca's (AZN) Imfinzi.
FDA Plans to Ease Requirements for Biosimilars' Interchangeable Status
MedPage Today· 3 days agoThe FDA on Thursday announced that biosimilars seeking an interchangeable status would no longer require studies showing that switching between a biosimilar and its branded ...