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A joint FDA advisory committee voted 19 to two on Friday in favor of the benefit-risk profile of Takeda’s Uloric (febuxostat) for treatment of excessive uric acid in the blood of gout patients. Read More
U.S. District Judge Theodore Chuang shot down the defendants’ arguments that a recent Supreme Court decision protecting foreign firms against U.S. lawsuits also extended to domestic corporations, allowing the litigation to go forward. Read More
Sen. Bernie Sanders (I-Vt.) was joined by Reps. Elijah Cummings (D-Md.), Ro Khanna (D-Calif.) and other Democrat lawmakers Thursday to announce new legislation aimed at curbing high drug prices in the U.S. Read More
The Supreme Court declined to consider Merck’s appeal of a California court ruling that overturned a $200 million jury award against Gilead over a hepatitis C drug patent. Read More
In their response, the AGs noted Pennsylvania Rules of Professional Conduct include a “safe harbor” provision allowing lawyers to make extrajudicial statements on various matters, including claims and defenses in litigation. Read More
The guidance also clarifies when applications will be dropped from the system due to nonpayment and includes a section on troubleshooting and staying up to date with guidance updates. Read More
In one of his first actions since assuming office on Monday, California Gov. Gavin Newsom signed an executive order requiring state officials to negotiate drug prices for the state’s Medicaid program. Read More
As the partial government shutdown neared the end of a third week, FDA Commissioner Scott Gottlieb announced via Twitter that the agency will re-allocate user fee money from drug reviews to cover post-market drug safety surveillance. Read More
The FDA unveiled a five-year strategy on Wednesday for its Sentinel post-market safety surveillance system, detailing major goals through the year 2023. Read More