2029, Disease and FDA Approval - Drug Discovery Digest

A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

Tobolowsky — The Rare Pediatric Disease Priority Review Voucher program has had a bit of a tumultuous history in its 12 short years of existence. Over 50 rare pediatric disease priority review vouchers have been awarded to date. We heard and felt the anxiety from many of our clients about the uncertainty this caused.

Disease

Disease FDA FDA Approval Government

Making a “Miracle” HIV Medicine

Codon

FEBRUARY 23, 2025

million new HIV infections by 2029, undermining progress toward the UN’s goal. Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By February, the U.S. Jerome Horwitz and Wolfram Ostertag.

Clinical Trials

Clinical Trials Virus Vaccine DNA

Drug Discovery Digest

A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

Making a “Miracle” HIV Medicine

Webinars

Stay Connected