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The epidemic-level rises in youth e-cigarette use is threatening the progress we’ve made toward reducing youth tobacco use.
Global reports show nearly 250 new cases of non-Hodgkin lymphoma in women with breast implants.
This focus is critical because, first and foremost, these drug products provide people with important therapies.
The accelerated approval pathway facilitates earlier approval of drugs that treat serious conditions.
The accelerated approval pathway may offer a faster route to approval for new treatments in significant, unmet medical needs.
These drugs, made from living organisms, are big moneymakers partly because they have little competition. It’s a different story in Europe.
Farm bill decriminalizes hemp, FDA still regulates products containing cannabis and compounds like cannabidiol.
The FDA wants to give prescribers and patients access to the most up-to-date information to guide treatment decisions.
“The result of this progress is that we openly talk about curing cancers that were recently fatal,” says Commissioner Gottlieb.
The FDA recently approved Vitrakvi for all cancers with specific gene mutation.
Talazoparib slowed disease progression compared to chemotherapy in EMBRACA study.
Human papillomavirus vaccine can prevent cervical, anal and oral cancers.
Checkpoint inhibitor immunotherapy, alone or in combination with chemotherapy, shows promise for advanced non-small-cell lung cancer.
The agency hopes to make better use of information from patients and providers.
Where appropriate, the FDA supports broader labeling of companion diagnostics.
The agency clarifies how test developers may use clinical evidence in public databases to show that their test is “clinically valid.”
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