Prefer Newsweek on Google to see more of our trusted coverage when you search. More than 100 mothers and advocates affected by a type of rare disease gathered outside the Food and Drug Administration ...
While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external ...
It is important for primary care providers to understand new federal regulations surrounding wearables, wellness and clinical ...
WASHINGTON, DC / ACCESS Newswire / March 26, 2026 / The Centers for Medicare & Medicaid Services (CMS) is preparing to launch an unprecedented federal pilot program that could furnish participating ...
The US Food and Drug Agency announced on March 9 new guidelines for testing biosimilar products, biologic drugs that are made by someone other than the inventor. Whereas a generic-drug manufacturer ...
A CNBC investigation revealed the proliferation of AFPs, which import prescription drugs from overseas in what U.S.
In the latest tranche of published warning letters, the US Food and Drug Administration (FDA) has continued to go after ...
Under the new priority voucher program (CNPV), the FDA has approved a new oral GLP-1 drug, Foundayo, offering an alternative ...
The FDA granted accelerated approval to tividenofusp alfa (Avlayah) for the treatment of mucopolysaccharidosis type II (MPS II), a rare disease also known as Hunter syndrome, the agency announced ...
The US Food and Drug Administration (FDA) has submitted its budget proposal to Congress, outlining its spending priorities ...
The FDA this month issued a warning letter to ImmunityBio regarding promotional statements about cancer drug Anktiva that the agency claims are “false or misleading.” The missive marks the first ...
When navigating the FDA approval process, ophthalmologists must be ready to “fight” on behalf of their findings, according to ...
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