Select Phase III Studies Of Melanoma Candidates
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With Bristol-Myers Squibb Co.’s ipilimumab cleared and Roche/Daiichi Sankyo’s BRAF inhibitor vemurafenib (RG7204) on track for a filing and perhaps approval this year, companies developing other melanoma drugs face a more complicated, competitive path to market.
Avadim Health argues National Advertising Division expects substantiation for its homeopathic topical claims at the same level FDA requires for NDAs. NAD also said although FTC’s competent, reliable scientific evidence standard is “flexible” to some degree, pain claims are held to a more rigid standard.