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RSS FeedPosted 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. ...
Posted by Michael Wonder on 13 Jul 2021
Biden in standoff with Democratic senators over who should lead FDA
13 July 2021 - Nearly six months into a presidency fully engulfed in a battle against a global pandemic, President Joe ...
Posted by Michael Wonder on 13 Jul 2021
Stryker announces the FDA clearance of the first biodegradable subacromial balloon spacer, filling a gap in the shoulder continuum of care
13 July 2021 - The InSpace balloon implant is a breakthrough solution for arthroscopic treatment of massive irreparable rotator cuff tears ...
Posted by Michael Wonder on 13 Jul 2021
Powerful House Democrats demand documents from Biogen about co-ordination with FDA on new Alzheimer’s drug
12 July 2021 - Two powerful House Democrats on Monday demanded documents from Biogen about the approval process, marketing, and ...
Posted by Michael Wonder on 12 Jul 2021
FDA to announce new warning on J&J COVID vaccine related to a rare auto-immune disorder, report says
12 July 2021 - About 100 preliminary reports of Guillain-Barre syndrome have been detected after 12.8 million doses of the J&J ...
Posted by Michael Wonder on 12 Jul 2021
FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma
12 July 2021 - On 9 July 2021, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) in combination ...