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FDA review of drugs is slowing while application delays are growing, analysis finds 

October 20, 2025
Pharmalot Columnist, Senior Writer
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STAT+ | FDA review of drugs is slowing while application delays are growing, analysis finds

The data signals a "risk we believe may not be fully appreciated given recent market highs," RBC Capital Markets analysts cautioned.

By Ed Silverman


STAT+ | CBO says revised cost of orphan drug exemptions will add $3.9 billion to Medicare

The revision reflected the addition of three drugs — Keytruda, Opdivo, and Darzalex — that were not included in the original CBO estimate.

By Ed Silverman


STAT+ | Merck rolls out some showstoppers at a major cancer conference. Its future may depend on them

Doctors applauded Merck's impressive Keytruda results and next-gen ADC data at ESMO 2025, a glimpse into how the firm sees its post-Keytruda future.

By Andrew Joseph



Gilead's booth at the ESMO conference in Berlin
Andrew Joseph/STAT

STAT+ | At ESMO, AstraZeneca and Gilead square off in triple-negative breast cancer

At the ESMO Conference 2025, both companies reported successes in treating triple-negative breast cancer, with experts discussing which drug had the edge.

By Andrew Joseph


STAT+ | mRNA Covid shots may boost the effects of certain cancer treatments, study suggests

Patients with advanced cancers who received a Covid vaccine before getting an immunotherapy drug lived significantly longer than patients who did not.

By Angus Chen


STAT+ | With questions surrounding its gastric cancer drug, Amgen fills in some gaps 

Revised analysis of data on the drug, called bemarituzumab, had led to uncertainty about benefits, amid questions about possible safety issues as well.

By Andrew Joseph


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