|Articles|October 1, 2018

Does being an orphan speed up FDA approval?

Newsletter

Lead with insight with the Pharmaceutical Executive newsletter, featuring strategic analysis, leadership trends, and market intelligence for biopharma decision-makers.

Subscribe Now!

Related Content

Brent Saunders: Eyeing New Horizons

ByMichael Christel

December 12th 2025

Image Credit: Adobe Stock Images/Pakin. Uplizna is a humanized, afucosylated IgG1 kappa monoclonal antibody that was designed to target CD19 to induce rapid, deep, and durable B-cell depletion.

FDA Approves Amgen's Uplizna for Generalized Myasthenia Gravis With Positive AChR or MuSK Antibodies

ByDavy James

December 12th 2025

The GLP-1 Gold Rush

ByNicholas Jacobus

December 12th 2025

TrumpRX Has a Blind Spot and It Can Redefine Patient Access

ByPouria Sanae

December 12th 2025

How Are Global Regulatory Agencies Adjusting Their Policies for Biosimilars?

ByMike Hollan,Gillian Woollett

December 12th 2025

Does being an orphan speed up FDA approval?

Newsletter

Related Content

Brent Saunders: Eyeing New Horizons

FDA Approves Amgen's Uplizna for Generalized Myasthenia Gravis With Positive AChR or MuSK Antibodies

The GLP-1 Gold Rush

TrumpRX Has a Blind Spot and It Can Redefine Patient Access

How Are Global Regulatory Agencies Adjusting Their Policies for Biosimilars?

Trending on PharmExec

Brent Saunders: Eyeing New Horizons

TrumpRX Has a Blind Spot and It Can Redefine Patient Access

FDA Approves Amgen's Uplizna for Generalized Myasthenia Gravis With Positive AChR or MuSK Antibodies

The GLP-1 Gold Rush

Lilly’s Retatrutide Displays Positive Topline Results in Successful Phase III Trial