Pink Sheet reporter looks at the biggest US FDA and pharma industry stories of the week, including the status of US FDA user fee renewal legislation, new real-time oncology review program guidance, Biogen’s ALS accelerated approval play, and Teva settling opioid litigation.

Pink Sheet reporter and editors discuss another project to improve clinical trial diversity in the US, the Patent Trial and Appeal Board director review process, and the FDA promoting its head of controlled substance policy to deputy CDER director.

A special podcast looks at the implications for FDA-regulated sectors, from the abortion pill and OTC daily and emergency contraceptives to intrauterine devices and period-tracking apps, of the US Supreme Court’s historic overturning of Roe v. Wade.

Pink Sheet reporters and editors discuss the FDA’s latest COVID-19 vaccine emergency use authorization, activities during the FDA commissioner’s remaining time in office, and patients requesting a gene therapy risk management plan.

Pink Sheet reporters and editors discuss new changes to the Senate drug pricing bill, the FDA’s decision to call a second advisory committee meeting for Amylyx’s ALS drug, and Covis’ request to skip a vote during the hearing on Makena’s withdrawal.

Join our China-based content team for this inaugural Chinese-language podcast discussing selected recent hot topics impacting the biopharma industry in China, including bispecific antibodies, antibody-drug conjugates and new regulatory policies designed to speed product approvals. 

Reporters and editors from the Pink Sheet and sister publications covering the medical device and health, beauty and wellness sectors look at Califf’s goals, accomplishments and trials during the early days of his second term.

Pink Sheet reporter and editors discuss the first mark-up of the House FDA user fee bill, the likelihood of more postmarketing quality requirements for drug manufacturers, and the significance of the shrinking number of FDA advisory committee meetings.