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The FDA canceled its scheduled Oncologic Drugs Advisory Committee (ODAC) meeting last week during which it had planned to discuss two cancer drugs that hold accelerated approvals (AA). Read More
Supreme Court justices heard oral arguments this week in a lawsuit — the American Hospital Association (AHA) vs. HHS Secretary Xavier Becerra — centering on a 2018 HHS decision to slash outpatient Medicare drug reimbursements to 340B hospitals by almost 30 percent. Read More
Several states and the Department of Justice have been seeking to stop pay out of the settlement, charging that the Sacklers weren’t held sufficiently accountable. Read More
Along an almost entirely Democratic party line vote, the House of Representatives voted 221 to 212 yesterday to pass a continuing resolution funding the government through Feb. 18 of next year. Hours later the Senate passed the bill in a 69-28 vote. Read More
The FDA has sent a complete response letter (CRL) to BeyondSpring Pharmaceuticals denying approval of the company’s new drug application (NDA) for plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN), an abnormally low white blood cell count. Read More
Negotiations hit an impasse in the House yesterday on a stopgap measure to fund federal agencies beyond an upcoming deadline on Friday night. Read More
With government funding set to expire on Friday, the House could vote as soon as today on a stopgap measure to avert a shutdown and keep federal agencies operating. Read More