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Amylyx's ALS drug finally scores FDA approval, but that's just the tip of the iceberg for ALS research, founders say | Fierce Pharma
Summary of FDA's Expedited Programs | Download Scientific Diagram
Summary of NDA Approvals & Receipts, 1938 to the present | FDA
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2021 FDA approvals
Summary of FDA Expedited Development and Review Programs. | Download Scientific Diagram
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A Survey of the Structures of US FDA Approved Combination Drugs | Journal of Medicinal Chemistry
Introduction to EPARs and FDA Approval Packages: Finding and Analyzing Unpublished Information about Pivotal Studies 23 June 2008 Session Chair: Amy N. - ppt download
Rush to judgement?
A look at three recent FDA approvals supported by RWE | Aetion
FDA's Expedited Review Process: The Need for Speed
Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices - ScienceDirect
Alexander Tin on Twitter: "As promised yesterday, @US_FDA has posted its "Summary Basis for Regulatory Action" document on @pfizer-@BioNTech_Group's COVID-19 vaccines full approval https://t.co/gytKOptwYf https://t.co/TZrlSrhm2C" / Twitter
FDA efficiency for approval process of COVID-19 therapeutics | Infectious Agents and Cancer | Full Text
Steven Warach on Twitter: "Happy tPA Day! 25 years ago today FDA approved alteplase for ischemic stroke. The beginning of the stroke reperfusion revolution! https://t.co/BC4fZyt9VZ @NINDStrials @US_FDA @American_Heart @genentech @LoneStarStroke https ...
Can we learn lessons from the FDA's approval of aducanumab? | Nature Reviews Neurology
Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs - ScienceDirect
Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices - ScienceDirect
U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab
New Drug Therapy Approvals 2020 | FDA
Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies | NEJM
U.S. FDA Approved Drugs from 2015–June 2020: A Perspective | Journal of Medicinal Chemistry