regulatory

News

GSK and Pfizer could see a resurgence in sales of their RSV vaccines if new recommendations at a CDC expert meeting are confirmed by agency leaders.

Market Access

The Joint Clinical Assessment (JCA) framework took effect on 12th January 2025, and its impact is top of mind among pharma innovators today.

News

Robert F Kennedy Jr's controversial views on vaccines were on display this week during an interview that touched on delays to a COVID-19 shot review.

News

The FDA has said it intends to reduce or replace animal testing of some medicines, including monoclonal antibodies, with other methods.

News

The CHMP has advised against EU approval of Eli Lilly's Alzheimer's drug Kisunla, potentially handing an advantage to Eisai/Biogen's rival drug.

News

HHS Secretary Kennedy has said he intends to save $1.8bn per year, thanks to another wave of job cuts affecting the FDA, CDC, NIH, and CMS.