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In major shift, FDA to start releasing rejection letters shortly after they’re issued 

September 4, 2025
Pharmalot Columnist, Senior Writer
FDA Commissioner Marty Makary
Andrew Harnik/Getty Images

STAT+ | In major shift, FDA to start releasing rejection letters shortly after they're issued

The letters, which detail the FDA's concerns about a product, have generally not been made public before, creating transparency concerns.

By Andrew Joseph and Ed Silverman


STAT+ | Trump administration confirms plan for PEPFAR to distribute Gilead's new HIV prevention drug

The deal is a bridge to a longer-term solution in which Gilead licensed its drug to generic makers but they won't have product for two years.

By Ed Silverman and Jason Mast


STAT+ | Sanofi shares drop after disappointing trial results

The company is working to develop medicines for immunological and inflammatory conditions, building on the success it's had with Dupixent.

By Andrew Joseph



Courtesy Atlas Venture

STAT+ | Biotech VC raises $400 million 'opportunity' fund in sign of possible industry rebound

This is the third time Atlas, a biotech VC firm, has raised an opportunity fund. It last raised $300 million for one in 2021. 

By Allison DeAngelis


STAT+ | Is biotech back? Don't jinx it, but the signs are encouraging

In this edition of "Adam's Biotech Scorecard," Adam sees signs of hope for the industry, even if it's too early to declare a biotech recovery.

By Adam Feuerstein


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