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For years, sponsors, researchers and other experts have urged the FDA to consider metastasis-free survival a primary endpoint for trials aimed at nmCRPC. Read More
Gottlieb said the agency must develop evidence-based guidelines rather than consensus guidelines, which rely too much on “what we currently know.” Read More
Sen. Mike Enzi (R-Wyo.) asked the FDA Monday to clarify an agency report about hiring and retention with more details on succession policies. Read More
Kaléo’s massive, artificially inflated price hikes for its naloxone auto-injector Evzio have cost taxpayers more than $142 million over the past four years, says a new Senate report. Read More
The FDA responded that the drugmaker is “nowhere close” to meeting the requirements for a preliminary injunction, including proving the complaint’s likelihood of success. Read More
The state of Kentucky filed a lawsuit against Teva, alleging the drugmaker’s off-label promotion of two drugs for cancer pain has exacerbated the opioid epidemic. Read More
A Superior Court jury in Hartford, Connecticut found Boehringer Ingelheim not liable for the severe internal bleeding a Pensacola, Florida, man suffered after using the company’s blood thinner Pradaxa. Read More