Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

A Baker’s Dozen Of US FDA Efficacy Approvals Using Real World Evidence

Aug 08 2018

• By Bridget Silverman

Related Content

BioMarin's Brineura Approval Shows FDA's Open Door For Orphan Drugs

May 02 2017

Kalydeco Expands Indication Without Clinical Data; Keytruda Is Latest Bladder Cancer Approval

May 21 2017

Real-World Evidence At US FDA: Bavencio, Blincyto Approvals Point Way Toward Broader Use

Aug 08 2018

Roche’s External Control Arms Show What Real-World Evidence Can Look Like In Practice

Jun 14 2018

Lutathera’s Broad Tumor Indication Aided By Expanded Access Data

May 18 2018

Keeping Track: Shionogi, Fresenius Kabi Join July Approval Parade; Busy August Expected

Aug 05 2018

Emflaza's 505(b)(2) Pathway Review: Rare, But With Precedent

Apr 01 2017

Related Companies

Fresenius SE & Co. KGaA

BioMarin Pharmaceutical Inc.

Amgen, Inc.

Merck KGaA

Pfizer Inc.

Sanofi Genzyme

Recordati SpA

Wellstat Therapeutics Corporation

Aegerion Pharmaceuticals, Inc.

Advanced Accelerator Applications SA

Vertex Pharmaceuticals Incorporated

Asklepion Pharmaceuticals, LLC

BTG plc

Additional Topics

United States Drug Approval Standards Drug Review Regulation BioPharmaceutical

More from Approval Standards

More from Pathways & Standards

Twitter feed RSS feed RSS feed

About UsOpens in new window
Meet the TeamOpens in new window
RSS FeedOpens in new window

Contact Us
Customer Service
Subscribe
AdvertisingOpens in new window
Feedback

Terms and ConditionsOpens in new window

Privacy PolicyOpens in new window