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Various supply-chain resilience measures are needed to ensure U.S. drug production before the next pandemic or other natural disaster, a National Academy of Sciences, Engineering and Medicine (NASEM) expert panel advised in a new report. Read More
Nearly $80 million will be invested to bolster commercial-scale manufacturing for companies producing innovate technologies, such as cell and gene therapies. Read More
Almost a year after admitting it manipulated safety data for its anemia drug roxadustat, Fibrogen has disclosed that the Securities and Exchange Commission (SEC) is investigating its actions. Read More
Nevada’s action marks a growing trend among states to try to rein in the rising costs of prescription drugs — especially as the latest federal attempt at allowing Medicare to negotiate the price of some medications is stalled in the Senate. Read More
AstraZeneca’s and Sanofi’s investigational long-acting antibody aimed at infants with respiratory syncytial virus (RSV) had positive results in its phase 3 trial, making it the first potential immunization to show protection against RSV in the general infant population in a phase 3 trial, the companies said. Read More
Gantenerumab, another anti-amyloid antibody, is entering the race to find an effective therapy for Alzheimer’s disease (AD), with an ambitious four-year study in presymptomatic, amyloid-positive subjects. Read More
To clarify the FDA’s recommendations on quickly and effectively removing potentially harmful drugs and devices from the market, the agency has published a final guidance focused on recall readiness. Read More
The FDA has begun releasing a court-mandated trove of documents pertaining to the agency’s review of Pfizer/BioNTech’s COVID-19 vaccine — which the agency authorized for emergency use in December 2020 before granting full approval in August 2021. Read More