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 ...
A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...
Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...
8don MSN
Exclusive-US FDA delays two drug reviews in new voucher program after safety, efficacy concerns
Jan 15 (Reuters) - The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration ...
On January 15, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 25-01, a favorable opinion analyzing a pharmaceutical manufacturer’s ...
Connecticut hospitals provide care to all patients, regardless of their ability to pay, and invest millions in addressing community health needs. Despite facing negative operating margins —spending ...
On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B ...
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