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The FDA will consider granting orphan status for different gene therapies—even ones in the same class as a previously designated orphan treatment—based on how the therapy is delivered, a high-ranking CBER official said Friday at the Food and Drug Law Institute’s annual meeting in Washington, D.C. Read More
There is “little appetite on the part of donors to establish new global funding instruments specifically to address antimicrobial resistance,” the WHO says. Read More
The Department of Justice has entered the legal battle against Mallinckrodt over HP Acthar gel, joining a pair of whistleblower lawsuits that allege a company the drugmaker acquired bribed doctors to push the drug among other unlawful tactics. Read More
Bids are due by the end of the month that FDA officials hope will revolutionize the agency’s Sentinel database, CDER Director Janet Woodcock told a standing-room only crowd at the Food and Drug Law Institute’s annual meeting in Washington, D.C, on Thursday. Read More