Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

Accelerated Approval Makes Big Splash In 2021 Novel Agents, Despite Crackdown On ‘Dangling’ Cancer Claims

Jan 19 2022

• By Bridget Silverman

Big splash — • Source: Alamy

Related Content

From ‘Accelerate’ To ‘Confirm’: US FDA Launches Transparency Program On Cancer Drug Approvals

Oct 28 2021

239 Days: Oncopeptides' Myeloma Drug Pepaxto Comes Off Market Just Months After Accelerated Approval

Oct 23 2021

Oncology Accelerated Approval Re-Reviews: US FDA’s Pazdur Is Not Backing Down

Dec 20 2021

Biogen Pledges Aduhelm Confirmatory Data By 2026, Renewing Spotlight On FDA’s Lengthy Original Plan

Dec 16 2021

Beyond Aduhelm: OIG Review Will Put FDA’s Entire Accelerated Approval Program Under Microscope

Aug 05 2021

A Matter Of Precedent: US FDA Sometimes Labors Under Weight Of Unpopular Or Unfavorable Decisions

Sep 14 2020

FDA’s Mismanaged Aduhelm Review: What Went Wrong

Jul 07 2021

Medicare Aduhelm Coverage Policy Overrules FDA: Can Two Wrongs Make A Right?

Jan 13 2022

US FDA’s 2021 Novel Approvals: A Closer Look

Jan 06 2022

First-In-Class Drugs Made Up More Than Half Of US FDA’s Novel Approvals Last Year

Jan 08 2022

As Aducanumab’s US FDA Review Progressed, Support Grew For Accelerated Approval

Jun 23 2021

Pazdurcanumab: US FDA’s Top Cancer Official Weighs In On That Big Neurology Approval

Jun 10 2021

Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial

Jun 08 2021

US FDA’s Most Controversial Drug Approval Decisions, From A To Z

Jun 05 2021

Related Companies

Biogen, Inc.

Eisai Co., Ltd.

Sarepta Therapeutics, Inc.

Oncopeptides AB

BioMarin Pharmaceutical Inc.

Pfizer Inc.

Gilead Sciences, Inc.

GSK plc

Merck & Co., Inc.

Regeneron Pharmaceuticals, Inc.

Johnson & Johnson

Astellas Pharma, Inc.

Seagen Inc.

Additional Topics

United States Approvals Review Pathway Drug Approval Standards Drug Review Regulation Pink Sheet Perspectives BioPharmaceutical

More from United States

More from North America

Twitter feed RSS feed RSS feed

About Us

Meet the TeamOpens in new window
RSS FeedOpens in new window

Contact Us

Customer Service
SubscribeOpens in new window
AdvertisingOpens in new window
Feedback

Terms and ConditionsOpens in new window

Privacy PolicyOpens in new window

Copyright © 2025 Pharma Intelligence UK Limited (Citeline), a Norstella company Pharma Intelligence UK Limited is a company registered in England and Wales with company number 13787459 whose registered.