Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...
The FDA has authorized urcosimod 0.05% for single-patient expanded access, or compassionate use, in a patient with ...
The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
3d
Pro-life organization calls on HHS and FDA to suspend abortion pill approval, tighten safety rules
Live Action alleges "reckless distribution" of the abortion drug mifepristone, urging the Trump administration to suspend its ...
The U.S. Food and Drug Administration (FDA) has accepted a new drug application for gedatolisib in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), PIK3CA ...
In the draft guidance, the agency discusses how sponsors can leverage MRD and complete response rates as near-term efficacy measures and speed new therapies to market.
Gedatolisib's NDA for advanced breast cancer treatment has been accepted by the FDA, with a priority review and a PDUFA date ...
ImmunityBio stock rose 19.8% after FDA meeting on ANKTIVA bladder cancer treatment. Company to submit additional data within ...
The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies ...
The FDA commissioner's effort to shorten the review of drugs favored by the Trump administration is causing alarm across the ...
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