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New generic drug approvals in 2018, 2019 and 2020 yielded $53.3 billion in savings, according to a new FDA report that analyzed results from 2,400 approved new generic drug applications. Read More
The day a bench trial was slated to begin in Delaware federal court on Gilead’s five patent disputes with generic drug makers who were poised and ready to make copies of Gilead’s two HIV blockbuster drugs and its hepatitis B drug, the company announced that it had settled the disputes. Read More
Political pressure and internet-bred conspiracy theories have eroded one of the FDA’s prime functions — the communication of scientific truth, FDA Commissioner Robert Califf said at the annual meeting of the Regulatory Affairs Professional Society (RAPS) taking place in Phoenix this week. Read More
President Biden signed an executive order Monday authorizing a new initiative to help grow U.S. biomanufacturing, curtail dependence on foreign suppliers for critical supplies like active pharmaceutical ingredients (APIs) and establish and train a highly skilled workforce. Read More
There are currently no approved pharmaceutical treatments specifically indicated for the treatment of acute lower back pain, the company said. Read More
In its 2022 Focus Areas of Regulatory Science report released last week, the FDA adds to its list of regulatory priorities research efforts in oncology and rare disease. Read More