We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Following a year in which vaccine manufacturing plant Emergent BioSolutions spent many months in the headlines for botching 75 million Johnson & Johnson (J&J) COVID-19 vaccines, the federal government and the troubled company have parted ways. Read More
Democrats are reportedly set to meet with the Senate parliamentarian today to start discussing healthcare components in the Build Back Better Act — and to gauge whether the chamber’s gatekeeper will object to any provisions included in the $1.75 trillion package. Read More
The FDA has revised its fiscal 2022 Generic Drug User Fee Act (GDUFA) II research priorities based on feedback gleaned from a June public workshop in which generic drugmakers critiqued the agency’s fiscal 2021 initiatives. Read More
Several different COVID-19 booster shot combinations appear to improve protection against infection but the messenger RNA (mRNA)-based jabs from Pfizer and Moderna might be the most effective. Read More
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