Amylyx Pharma: FDA Extends PDUFA Date For AMX0035 - Quick Facts
nasdaq.com
Amylyx Pharma: FDA Extends PDUFA Date For AMX0035 - Quick Facts
(RTTNews) - Amylyx Pharmaceuticals, Inc. (AMLX) announced the FDA has extended the review timeline of the New Drug Application for AMX0035 for the treatment of amyotrophic lateral sclerosis. The updated PDUFA goal date is September 29, 2022.
Jun 3, 2022
Related Products
FDA Bla Review Timeline PDUFA
FDA Midd PDUFA
FDA Open PDUFA
#Prescription Drug User Fee Act Prescription Drug Approval Process
TherapeuticsMD Announces FDA Acceptance of New Drug Application and Prescription Drug User Fee Act Date for Yuvvexy (TX-004HR)
TherapeuticsMD Announces FDA Acceptance of New Drug Application and Prescription Drug User Fee Act Date for Yuvvexy (TX-004HR)
marketscreener.comSep 19, 2016
Reauthorization of the Over-the-Counter Monograph Drug User Fee Program | The U.S. Senate Committee on Health, Education, Labor & Pensions
Reauthorization of the Over-the-Counter Monograph Drug User Fee Program | The U.S. Senate Committee on Health, Education, Labor & Pensions
senate.gov8 months ago
Top videos
Understanding the Prescription Drug User Fee Act (PDUFA)
0:49
Understanding the Prescription Drug User Fee Act (PDUFA)
YouTubeLead With Logic
285 viewsNov 28, 2024
Prescription Drug User Fee Act (PDUFA) Explained: How FDA User Fees Work and Why They Matter
2:53
Prescription Drug User Fee Act (PDUFA) Explained: How FDA User Fees Work and Why They Matter
YouTubeFriends of Cancer Research
3 weeks ago
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration
51:01
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration
YouTubeU.S. Food and Drug
7.8K viewsMay 25, 2023
Prescription Drug User Fee Act Prescription Drug Costs
S. 622, Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 and S. 330, HIV Organ Policy Equity Act | The U.S. Senate Committee on Health, Education, Labor & Pensions
S. 622, Animal Drug and Animal Generic Drug User Fee Reauthorization Act of 2013 and S. 330, HIV Organ Policy Equity Act | The U.S. Senate Committee on Health, Education, Labor & Pensions
senate.gov
Mar 20, 2013
President Trump touted weight-loss drug costs as proof of his administration's progress on lowering prescription prices, saying that "the fat drug, F-A-T, for fat people" now costs far less in the U.S. than before and is in line with prices overseas. https://cbsn.ws/4pc96Jg | CBS News
1:14
President Trump touted weight-loss drug costs as proof of his administration's progress on lowering prescription prices, saying that "the fat drug, F-A-T, for fat people" now costs far less in the U.S. than before and is in line with prices overseas. https://cbsn.ws/4pc96Jg | CBS News
FacebookCBS News
113.9K views2 months ago
Medicare's new spending cap in 2025
3:23
Medicare's new spending cap in 2025
CBS NewsAimee Picchi
Dec 20, 2024
Understanding the Prescription Drug User Fee Act (PDUFA)
0:49
Understanding the Prescription Drug User Fee Act (PDUFA)
285 viewsNov 28, 2024
YouTubeLead With Logic
Prescription Drug User Fee Act (PDUFA) Explained: How FDA User Fees Work and Why They Matter
2:53
Prescription Drug User Fee Act (PDUFA) Explained: How FDA Use…
3 weeks ago
YouTubeFriends of Cancer Research
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration
51:01
OTC Monograph Drug User Fee Program (OMUFA): Understandin…
7.8K viewsMay 25, 2023
YouTubeU.S. Food and Drug Administration
Biotech FDA Decisions September 2025 | PDUFA Calendar & Outlook
4:51
Biotech FDA Decisions September 2025 | PDUFA Calendar & Outlook
185 views4 months ago
YouTubeShareTreck
Dr. Woodcock's Remarks at the Prescription Drug User Fee Act (PDUFA) VII Public Meeting - 9/28/2021
6:10
Dr. Woodcock's Remarks at the Prescription Drug User Fee Act (P…
982 viewsSep 29, 2021
YouTubeU.S. Food and Drug Administration
Syndax Pharmaceuticals, Inc.: Syndax Announces PDUFA Action Date Extension for Revumenib NDA for Relapsed or Refractory KMT2Ar Acute Leukemia
Syndax Pharmaceuticals, Inc.: Syndax Announces PDUFA Actio…
Dec 26, 2024
finanznachrichten.de
PDUFA VII: A Vital Reauthorization
1:26:15
PDUFA VII: A Vital Reauthorization
399 viewsMar 28, 2022
YouTubeResearchAmerica
Characterizing FDA’s Approach to Benefit-Risk Assessment through…
2.9K viewsMay 29, 2019
YouTubeDuke Margolis
3:28
PDUFA V, the FDA, and the Need for Flexibity
982 viewsOct 3, 2013
YouTubeRare Disease Report
22:41
Introduction to PDA (Pathological Demand Avoidance)
119.1K viewsJan 21, 2021
YouTubePDA Society
9:19:10
SMA Patient-Focused Drug Development Meeting with the FD…
2.8K viewsApr 18, 2017
YouTubeCure SMA
1:40:21
Prescription Drug User Fee Act and Biosimilar User Fee Amendments …
13 views4 months ago
YouTubeU.S. Food and Drug Administration
7:42:41
FDA Regulatory Education for Industry (REdI) Annual Conferenc…
9.9K viewsJun 5, 2023
YouTubeU.S. Food and Drug Administration
0:58
Big FDA Calls This Month | PDUFA Outlook October 2025
565 views4 months ago
YouTubeShareTreck
7:46:19
FDA Regulatory Education for Industry (REdI) Annual Conferenc…
5.2K viewsJun 6, 2023
YouTubeU.S. Food and Drug Administration
55:41
2025 FDA Financial Public Meeting
783 views4 months ago
YouTubeU.S. Food and Drug Administration
1:05:36
PDPA webinar
1.5K viewsAug 18, 2021
YouTubeNTUC LearningHub
Prescription Drug User Fee Act Waivers, Exemptions, and Refund…
2.7K viewsFeb 6, 2020
YouTubeU.S. Food and Drug Administration
2:59
Using To Use PDUFA Dates For Swing Trading
856 viewsMar 8, 2020
YouTubeSocrates Trading
1:05
Faster Than a Needle: Golden Discusses Anaphylm Ahead of PD…
299 views3 weeks ago
YouTubeHCPLive
6:55
Formal Meetings between the FDA and Sponsors or Applicants of PD…
64 views4 months ago
YouTubeRegulatory Affairs 101
0:57
Dan Pezzetta - Summer Series 2022: Prescription Drug User Fee Act (P…
408 viewsJul 12, 2022
YouTubeEveryLife Foundation for Rare Diseases
3:32
Andrew Emmett on PDUFA and the 2012 BIO International Convention
274 viewsApr 12, 2012
YouTubeBiotechnology Innovation Organization
13:21
Overview of the FDA Product-Specific Guidance Program
1.7K viewsMay 14, 2021
YouTubeU.S. Food and Drug Administration
1:00:28
Writing the “Indications and Usage” Section of Labeling: FDA’s New Dr…
1.9K viewsApr 13, 2020
YouTubeU.S. Food and Drug Administration
1:01
23180-56 Blender Nutri Boost Russell Hobbs
133.5K viewsApr 22, 2016
YouTubeRussell Hobbs Polska
2:21
What does the FDA do after drugs are approved?
57.8K viewsSep 6, 2023
YouTubeU.S. Food and Drug Administration
6:01
Carry me - Stampeders
123.2K viewsOct 23, 2015
YouTubecorinne1962
19:47
Drug Development and FDA Review Process
1.8K viewsJul 17, 2024
YouTubeMichigan Medicine
See more videos
Static thumbnail place holder