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Research
Biotech
Clinical Data
Venture Capital
Deals
Medtech
Devices
Diagnostics
AI and Machine Learning
CRO
Special Reports
Trending Topics
Cell & Gene Therapy
COVID-19
Emerging Biopharma
Podcasts
Resources
Questex Events
Industry Events
Webinars
Podcasts
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Subscribe
Fierce Pharma
Fierce Biotech
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Fierce Life Sciences Events
Complete Response Letter
Biotech
Akebia is taking the fight to the FDA months after rejection
Akebia is formally disputing FDA's decision to reject its anemia treatment, defending the treatment's risk-benefit profile.
Max Bayer
Nov 4, 2022 12:02pm
Mesoblast keeps hopes of cell therapy approval alive
Oct 3, 2022 9:40am
Omeros' Hail Mary throw for blood clot med delayed at FDA
Aug 17, 2022 11:21am
Merck responds to FDA letter for chronic cough med gefapixant
Aug 5, 2022 10:21am
BioMarin's hemophilia A gene therapy delayed amid new FDA asks
Jun 1, 2022 10:02am
Sesen Bio reports regulator progress but trial issues linger
May 9, 2022 10:58am
