The International Coalition of Medicines Regulatory Authorities (ICMRA) is about to start two pilot projects on drug manufacturing inspections, a senior industry official said. Source: Drug Industry Daily

A newly proposed bill would make it easier for the FDA to expeditiously remove drugs marketed on accelerated approvals if they don’t live up to their clinical promise. Source: Drug…

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…

Gilead Sciences is touting a phase 3 win for its drug-antibody conjugate Trodelvy (sacituzumab govitecan-hziy), saying it significantly improved progression-free survival in women with metastatic, treatment-resistant breast cancer. Source: Drug…

The FDA has approved GlaxoSmithKline’s blockbuster cancer drug Opdivo (nivolumab) in combination with chemotherapy for adult patients with resectable nonsmall-cell lung cancer (NSCLC). It is the first approved neoadjuvant treatment…

Novavax said it has finally put to bed manufacturing issues that might delay the FDA from authorizing its COVID-19 vaccine. Source: Drug Industry Daily

A bill to initiate a prescription drug affordability board is making its way through Washington statehouses. Source: Drug Industry Daily

The U.S. pharmaceutical industry had 274 drug recalls in 2021, the lowest number in five years. The industry saw 344 recalls in 2020. Source: Drug Industry Daily

Eli Lilly’s Olumiant (baricitinib), a powerful anti-inflammatory used to treat rheumatoid arthritis, has once again proven its mettle against COVID-19. Source: Drug Industry Daily

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. Source: Drug…