AI in clinical trials presents a data-driven model
Clinical trials are a significant part of the drug development cycle. However, the process has remained unchanged in recent ...
Overturning Chevron Doctrine Could Impact Medicare’s Drug Selections For Price Negotiations
Courts have long deferred to CMS’s decisions on implementation of laws that govern Medicare. The overturning of the Chevron ...
New weight loss drug decreases appetite without nausea — and can even burn calories
Scientists from the University of Copenhagen say they have developed a drug that decreases appetite while increasing calorie ...
RFK Jr. vow to purge FDA sets up collision with Big Pharma
Kennedy has been most vocal about the FDA, an agency that oversees nearly $3 trillion in medicines, food and tobacco products ...
‘Do your research’: Pet owner warns others after linking cat’s death to new arthritis drug
Some pet owners want a recall of a new arthritis drug for cats after their animals died, some in horrific ways, just days ...
Unlocking future medicines: The crucial role of clinical trials
Regeneron’s clinical trials are at the core of this mission. Regeneron is grateful to all clinical trial participants — ...
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Novavax Gets FDA Approval To Resume Testing Two Vaccines After Clinical Hold
The company explained that the U.S. Food and Drug Administration (FDA) removed its clinical hold on the studies, and will ...
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J&J gets FDA thumbs-up to begin clinical trials for its Ottava surgical robot
Johnson & Johnson MedTech has received a go-ahead from the FDA to begin human clinical trials of its Ottava surgical robot, ...
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Kezar’s Autoimmune Drug Hit With Second FDA Clinical Hold in as Many Months
Following patient deaths in a lupus trial that led to the termination of that program, Kezar’s autoimmune candidate ...
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FDA commissioner: We need action and higher-quality research on ultra-processed foods
Researchers, public health and health care groups, advocates, industry, and the public must put tackling diet-related disease ...
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FDA hits Kezar's zetomipzomib program with 2nd clinical hold in 2 months
The agency has placed a partial hold on the phase 2a PORTOLA trial evaluating the selective immunoproteasome inhibitor ...
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U.S. FDA Removes Clinical Hold on Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Phase 3 Trial
The FDA has cleared the Company to begin enrolling the planned Phase 3 trial following the determination that Novavax ...