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The FDA unveiled its new regenerative medicine oversight framework — the regulation of promising stem cell treatments, engineered tissues and cell therapies — by publishing four guidance documents focused on speeding development and clarifying the agency’s enforcement actions over the next three years. Read More
Amgen leveled new biosimilar patent infringement litigation against Mylan, after the generics manufacturer submitted an FDA application for its version of the company’s Neulasta (pegfilgrastim) therapy earlier this year. Read More
A health plan for a carpenters’ union filed a class action lawsuit against Celgene, claiming the drugmaker engaged in anti-competitive practices to maintain its monopoly on Thalomid (thalidomide) and Revlimid (lenalidomide). Read More
FDA Commissioner Scott Gottlieb told lawmakers the agency will work to break the stigma associated with medication-assisted treatments for opioid dependence and addiction. Read More
A federal judge declined to block Maryland’s new law on generic drug price-gouging that went into effect Oct. 1, but said a challenge based on the law’s vagueness can proceed. Read More
The FDA is streamlining its communications with generics manufacturers, and outlined its procedures for relaying the status of an ANDA review in a new manual for staff. Read More
The FDA formalized its guidelines for sponsors seeking reconsideration of scientific or regulatory issues early in the approval process for generic drugs, issuing a guidance that also affirms the agency’s response-time pledges. Read More