Sponsor of the Day:
Jerkmate
https://www.fda.gov/news-events/public-health-focus/fda-and-cannabis-research-and-drug-approval-process
FDA and Cannabis: Research and Drug Approval Process | FDA
Information about FDA and cannabis
drug approval processcannabis researchfda
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/surveillance
Surveillance: Post Drug-Approval Activities | FDA
drug approvalactivities fdasurveillancepost
https://www.fdli.org/2024/11/the-new-drug-approval-process-nda-submission-and-review/
The New Drug Approval Process: NDA Submission and Review - Food and Drug Law Institute (FDLI)
Apr 24, 2025 - The New Drug Approval Process: NDA Submission and Review A session from FDLI's Introduction to Drug Law and Regulation Recorded April 22-23, 2025 The New Drug...
drug approval processfood law institutenewndasubmission
https://www.statnews.com/2021/06/29/biogen-fda-alzheimers-drug-approval-aduhelm-project-onyx/
How Biogen used an FDA back channel to win Alzheimer's drug approval
Jul 31, 2023 - When Aduhelm’s prospects appeared dead, Biogen mounted a secret campaign to resurrect the drug and convince the FDA to approve it.
back channeldrug approvalbiogenusedfda
https://www.fdli.org/2024/11/the-new-drug-approval-process-introduction-to-new-drug-research-and-development/
The New Drug Approval Process: New Drug Research and Development - Food and Drug Law Institute...
Apr 24, 2025 - The New Drug Approval Process: New Drug Research and Development A session from FDLI's Introduction to Drug Law and Regulation Recorded April 22-23, 2025 The...
drug approval processfood law institutenewresearchdevelopment
https://reports.statnews.com/collections/all-reports/products/speed-and-safety-fdas-drug-approval
A guide to the FDA's drug approval pathways and processes | STAT Reports
Our latest report unpacks the differences between the different ways the FDA approves drugs, like accelerated approvals, fast-track designations, and emergency...
drug approvalstat reportsguidefdapathways
https://www.fdli.org/2024/03/introduction-to-fda-review-and-approval-of-biological-products/
Introduction to FDA Review and Approval of Biological Products - Food and Drug Law Institute (FDLI)
Jul 19, 2024 - Introduction to FDA Review and Approval of Biological Products A session from FDLI's Introduction to Biological Products, Including Vaccines, Biosimilars, Cell...
food drug lawinstitute fdliintroductionfdareview
https://www.businessinsider.com/analysts-fda-approval-of-amylyx-als-drug-relyvrio-amx0035-2022-9
Analysts on FDA Approval of Amylyx ALS Drug - Business Insider
Sep 30, 2022 - Analysts say the FDA's move to approve Axylyx's ALS drug is
fda approvalbusiness insideranalystsamylyxals
https://www.biopharmadive.com/news/travere-fda-approve-flispari-fsgs-kidney-disease/817415/
Travere wins long-awaited approval for kidney disease drug | BioPharma Dive
The clearance of Filspari in a condition known as FSGS ends a winding regulatory journey and unlocks a revenue opportunity believed to be worth more than $1...
drug biopharma divewins longkidney diseasetravereawaited
https://apnews.com/article/mdma-fda-psychedelic-therapy-ptsd-treatment-drug-bc2d7495035a9532876c3dcaf52a9761
Psychedelic drug MDMA faces questions as FDA considers approval for PTSD | AP News
May 31, 2024 - Federal health regulators are set to review the first request to approve the mind-altering club drug MDMA as a treatment for PTSD.
psychedelic drugfaces questionsap newsmdmafda
https://www.fda.gov/drugs/how-drugs-are-developed-and-approved/drug-and-biologic-approval-and-ind-activity-reports
Drug and Biologic Approval and IND Activity Reports | FDA
Drug and Biologic Approval and IND Activity Reports
activity reportsdrugbiologicapprovalind
https://endpoints.news/gsk-liver-drug-wins-fda-approval/
GSK liver drug wins FDA approval
GSK’s recent deal to license out a rare liver disease drug just got sweeter.
wins fda approvalgskliverdrug
https://www.foxbusiness.com/video/6388378825112
Cytokinetics' heart drug hits market after FDA approval | Fox Business Video
Cytokinetics President and CEO Robert Blum discusses the state of cardiovascular care in America on 'Mornings with Maria.'
fox business videohits marketfda approvalcytokineticsheart