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BioPharma Dive·Apr 29·1 min read
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FDA pilots real-time clinical trials as Amgen, AstraZeneca join proof-of-concept studies; AbbVie eyes KRAS biotech Kestrel

Apr 29, 2026·read at BioPharma Dive ↗RegulatoryNeutral

The U.S. Food and Drug Administration announced a pilot program for "real-time" clinical trials, designed to cut the lag between data collection and regulatory review.

AstraZeneca and Amgen have launched two proof-of-concept cancer studies under the new approach, agreeing to send endpoint and safety data to FDA scientists as the information becomes available.

AbbVie secured an option to acquire Kestrel Therapeutics, a startup developing a drug that targets multiple KRAS mutations. The company will fund KST-6051, which has just entered its first human testing phase.

These actions illustrate a broader push within the industry to speed drug development and secure promising oncology assets.

source

This writeup was produced by pharmadog from original reporting by BioPharma Dive.

Original headline: “FDA tests out ‘real-time’ clinical trials; AbbVie closes in on a KRAS biotech”

read at BioPharma Dive ↗
657 words · retrieved Apr 29
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companies & drugs in this story

companies
ABBVIE7LILLY7AMGEN4ASTRAZENECA4PFIZER4ELI LILLY CO2BRISTOLBRISTOL MYERS SQUIBBBRISTOL MYERS SQUIBB COEli Lilly and CoIONIS PHARMACEUTICALS INCJOHNSON & JOHNSON
drugs
ELREXFIO3KST-60513elranatamab3OZURDEXTECVAYLIUndiscloseddaratumumabdaratumumab + Gene Therapyteclistamab
topics
KRAS6Oncology5CRISPR/Cas93Multiple Myeloma2ApprovalBispecific AntibodyHepatologyMonoclonal Antibody

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