The FDA issued a direct final rule clarifying that non-animal testing methods can be used for drug and biological product safety testing, while HHS announced agency-wide actions to reduce reliance on laboratory animal testing as part of broader efforts to modernize federal biomedical research.
President Trump announced he will demand pharmaceutical companies separate combined vaccines into individual doses, one day after Health Secretary Robert F. Kennedy Jr. told an anti-vaccine conference that vaccine skeptics have a 'friend at the White House.'
A new modeling study published in The Lancet suggests that US Medicare's most-favored-nation pricing policy, which ties Medicare payments to prices in other high-income countries, could reduce US spending on brand-name drugs but incentivize pharmaceutical companies to increase prices or delay launches in lower-price markets like Europe.
The Trump administration announced a proposed rule requiring food companies to notify the FDA when introducing new additives under the 'generally recognized as safe' designation, closing a decades-old regulatory loophole that allowed manufacturers to self-certify ingredient safety without federal oversight.
California's highest court ruled Monday that pharmaceutical manufacturers of drugs deemed safe are not legally obligated to develop safer alternatives, delivering a victory to Gilead Sciences in a closely watched case that could have broad implications for the pharmaceutical industry.
A U.S. federal judge ruled that Biden-era FDA restrictions on prescribing the abortion drug mifepristone are unlawful and unjustified, ordering the Trump Administration to reconsider existing regulations. The decision comes as over 400 state lawmakers from all 50 states have signed an amicus brief demanding protection for telehealth abortion care access.
The Trump administration has proposed a new regulation through the Centers for Medicare & Medicaid Services targeting hospitals in the 340B Drug Pricing Program, aiming to prevent markups on discounted drugs for Medicare patients and potentially save consumers $1.1 billion next year.
Swiss pharmaceutical giant Roche has signed an exclusive licensing and collaboration agreement with Nurix Therapeutics for bexobrutinib, a protein degrader drug targeting B cell malignancies and blood cancers. The deal value is reported as up to $2.3 billion by one source and up to $3 billion by another.
The Trump administration plans to reclassify top NIH positions under Schedule F, making federal workers easier to fire and more politicized. Health Secretary Robert F. Kennedy Jr. is spearheading the move.
Six former FDA officials shared their reasons for leaving the agency following significant staffing cuts and policy changes under the Trump administration. The departures come amid concerns about the agency's capacity to respond to public health threats like the ongoing hantavirus outbreak.
The Supreme Court heard oral arguments on a case involving 'skinny labeling' practices that have significant implications for generic drug availability and access, with justices appearing to signal the practice may survive legal challenge.
Utah's medical board demanded immediate suspension of a state pilot program using artificial intelligence bots to renew prescriptions, citing concerns about patient safety and appropriate medical oversight.
President Trump has reclassified state-licensed medical marijuana from Schedule I to Schedule III under the Controlled Substances Act, marking a major federal policy change long sought by advocates. This represents the most significant shift in federal marijuana policy in decades.
CVS Health's Caremark pharmacy benefits unit reached a settlement with the U.S. Federal Trade Commission to curb controversial rebate practices in the pharmacy benefits market. The agreement requires Caremark to count consumer purchases from Trump's TrumpRx program toward insurance deductibles, mirroring a similar settlement previously reached with Cigna.
The White House is negotiating new drug-pricing agreements with smaller biotechnology companies facing the threat of 100% tariffs on imported medicines, according to multiple sources with knowledge of the meetings.
President Trump announced 100% tariffs on brand-name pharmaceutical imports and their active ingredients as part of efforts to bring drug manufacturing to the U.S. The administration is negotiating pricing deals with smaller drugmakers, with numerous carveouts expected.
