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RSS FeedPosted by Michael Wonder on 19 Jul 2021
G1 Therapeutics receives fast track designation from U.S. Food and Drug Administration for Cosela (trilaciclib) in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer
19 July 2021 - G1 Therapeutics today announced that the U.S. FDA has granted fast track designation to Cosela (trilaciclib) ...
Posted by Michael Wonder on 19 Jul 2021
BlueRock Therapeutics receives FDA fast track designation for DA01 in the treatment of advanced Parkinson’s disease
19 July 2021 - BlueRock Therapeutics announced that the U.S. FDA has granted fast track designation for DA01 for advanced Parkinson’s ...
Posted by Michael Wonder on 19 Jul 2021
Making sense of the FDA’s ‘indefensible’ decision to approve Aduhelm
19 July 2021 - There are three sides to every story that defies logic: the defenders’ side, the critics’ side and ...
Posted by Michael Wonder on 19 Jul 2021
Lilly and Incyte provide update on supplemental new drug application for baricitinib for the treatment of moderate to severe atopic dermatitis
16 July 2021 - Eli Lilly and Incyte announced today that the U.S. FDA will not meet the Prescription Drug User ...
Posted by Michael Wonder on 19 Jul 2021
AbbVie provides update regarding Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in the U.S.
16 July 2021 - AbbVie today announced the U.S. FDA did not meet the Prescription Drug User Fee Act action ...
Posted by Michael Wonder on 18 Jul 2021
U.S. FDA grants priority review for the biologics license application for Pfizer-BioNTech COVID-19 vaccine
16 July 2021 - Pfizer and BioNTech today announced that the U.S. FDA granted priority review designation for the biologics license ...
Posted by Michael Wonder on 17 Jul 2021
Merck announces U.S. FDA approval of Vaxneuvance (Pneumococcal 15 valent conjugate vaccine) for the prevention of invasive pneumococcal disease in adults 18 years and older caused by 15 serotypes
16 July 2021 - Clinical data supporting approval demonstrated non-inferior immune responses for the serotypes shared with PCV13 (1, 3, 4, ...
Posted by Michael Wonder on 16 Jul 2021
FDA approves new use of transplant drug based on real world evidence
16 July 2021 - Today, the U.S. Food and Drug Administration approved a new use for Prograf (tacrolimus) based on a ...
Posted by Michael Wonder on 16 Jul 2021
FDA approves belumosudil for chronic graft versus host disease
16 July 2021 - On 16 July 2021, the FDA approved belumosudil (Rezurock, Kadmon Pharmaceuticals), a kinase inhibitor, for adult ...
Posted by Michael Wonder on 14 Jul 2021
FDA chief tells reporter ‘move on’ when pressed on Biogen Alzheimer’s drug approval
14 July 2021 - Acting FDA Commissioner Dr. Janet Woodcock pushed back against questions from a journalist about the approval of ...
Posted by Michael Wonder on 14 Jul 2021
Patient impact statement: FDA approval of Kerendia to help slow kidney disease and failure associated with type 2 diabetes
14 July 2021 - The American Association of Kidney Patients today issued the following statement regarding the recent approval by the ...
Posted by Michael Wonder on 14 Jul 2021
FDA chief Janet Woodcock acknowledges agency may have misstepped in process leading up to Alzheimer’s drug approval
14 July 2021 - Acting FDA Commissioner Janet Woodcock acknowledged on Wednesday her agency may have misstepped in its handling ...
Posted by Michael Wonder on 14 Jul 2021
FDA grants Alkeus Pharmaceuticals breakthrough therapy designation for ALK-001 (C20-D3-vitamin A) for the treatment of Stargardt disease
14 July 2021 - Only drug to receive breakthrough therapy designation for Stargardt disease. ...
Posted by Michael Wonder on 14 Jul 2021
ASP3772 receives FDA breakthrough therapy designation
12 July 2021 - The U.S. FDA has granted breakthrough therapy designation for ASP3772 for the prevention of pneumonia and invasive ...
Posted by Michael Wonder on 14 Jul 2021
Harvard doctor urges FDA reforms after Biogen Alzheimer nod
13 July 2021 - Curtail biomarker use for clearance, Kesselheim writes in JAMA. ...