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Clinical trials often exclude key patient populations, including children and people living with HIV or hepatitis B or C.
NKTR-214 plus Opdivo as first-line therapy had an overall response rate of 48 percent.
Isatuximab improved progression-free survival in a Phase III study.
The law could create opportunities for hucksters and snake-oil salesmen to prey on those who are vulnerable.
The accelerated approval pathway facilitates earlier approval of drugs that treat serious conditions.
Brain cancer patient begins treatment with experimental vaccine.
A non-animal based model could potentially help replace dogs in future trials with new informatics tools.
New potential safety issues may emerge that were not seen in the studies conducted prior to approval.
Over the last five years, FDA has authorized more than 9,000 applications through the expanded access program.
Barriers to cancer treatment access come in many forms.
Joining a trial can be a good way to get promising experimental therapies, but you should carefully weigh the potential risks and benefits.
We learn through scientific advances, but also by listening to patients.
Prices should be able to adjust to reflect the value in how medicines are prescribed and the outcomes they deliver.
Novel drugs targeting unmet needs often don’t follow the traditional three phases of clinical trials.
LOXO-292 demonstrates durable antitumor activity in people with lung, thyroid and other cancers with RET mutations.
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