Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in ...
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...
The Swiss pharmaceutical company said the FDA backed a label expansion for the Pathway HER2 (4B5) test to identify patients with HR-positive, HER2-ultralow metastatic breast cancer who could be ...
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
Many or all of the products on this page are from partners who compensate us when you click to or take an action on their website, but this does not influence our evaluations or ratings. Our ...
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.
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