The agency says pairing drug sponsors with research institutions could cut development timelines by 6 to 12 months ...
June 22 (Reuters) - The U.S. Food and Drug Administration said on Monday it is launching a series of measures to speed up ...
WASHINGTON — Federal health officials announced a pilot program Monday to speed up early-stage clinical trials, which they ...
The US Food and Drug Administration (FDA) is seeking comments on a pilot program where qualified external institutions will ...
The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological ...
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and ...
The discussion covered plans to increase the agency's headcount and to expedite early through late-stage clinical development in the U.S.
The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...
Katie covers the impact of health technology on patients, clinicians, and businesses. Her stories explore the price tag of clinical AI, digital health at the FDA, and the boom in direct-to-consumer ...
CalciMedica, Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for ...
DemeRx is launching the first U.S. clinical trial of an ibogaine-derived drug candidate, marking a pivotal moment for a controversial psychedelic long sidelined by safety concerns.
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