FDA hopes for first-cycle approvals by putting applications in a system like the 'Program' used for new drug reviews.
FDA has proposed extending biosimilar review times and moving the products into a model similar to one used for NDAs in order to increase first-cycle approvals.
Biosimilars now receive a 10-month clock, but there is no formal structure in place to promote communication between
At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.
With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.
At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.
Policy experts and pharma executives react to President Trump’s executive order on “equalizing” drug prices between the US and comparable nations at the ISPOR 2025 conference.
New draft guidance on the third cycle of Medicare drug price negotiations goes against Merck and BMS expectations for their cancer drugs. The guidance also tackles Part B and renegotiated prices for the first time.
A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.
Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.
