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The FDA introduced changes to its regulations to make experimental drugs more available to seriously ill patients who have exhausted other treatment options.
The FDA has given fast-track status to a post-surgical drug being developed by Wyeth Pharmaceuticals and Progenics Pharmaceuticals, the companies said July 17.
Cancer drug development programs continue to receive most of the FDA’s fast-track designations, according to the Tufts Center for the Study of Drug Development (CSDD).
Congress, the FDA and industry are in the midst of pushing a number of initiatives to bolster falling drug approval rates, a prominent industry analyst says.
An experimental cervical vaccine under development by GlaxoSmithKline (GSK) induces at least twice as many antibodies against cancer-causing viruses in females 10 to 14 years old compared to females 15 to 25 years old.
The FDA’s Office of Generic Drugs (OGD) announced it will grant expedited review status to all applications in the review queues for generic versions of amantadine HCl and rimantadine HCl in all dosage forms.