Regulators paused testing of Regenxbio's Hunter syndrome gene therapy for the second time this year after investigators detected masses on the spines of five pa

Roche is building its metabolic portfolio with a deal worth up to $2.3 billion for a shot designed to spur weight loss while sparing muscle tissue.

A STAT series examines how massive federal health care funding cuts are forcing rural hospitals and states to scramble, with Maine particularly hard hit.

A detailed look inside how the partners' gambit on an mRNA cancer vaccine overcame doubts and logistical hurdles to show positive results.

The state's biopharma sector is recovering this year after a slump that saw headcount shrink for the first time in over two decades.

Seed and Series A rounds in Massachusetts are shrinking as funding concentrates on less risky, later-stage companies.

The agency's digital health chief said guidance on generative AI device policies is expected soon, as the technology's use in health care expands.

President Trump's promise to make expensive weight loss drugs widely available to low-income Americans through Medicaid is not materializing.

A court loss for Merck is among the developments in the ongoing battle over Medicare's new drug price negotiation authority.

The pop star is entering the biotech space with a new company, amid other biotech news including FTC challenges to Amgen's Enbrel patent strategy.

The legal theory used to restrict gender-affirming care for minors could be applied broadly to other Medicaid drug coverage, experts warn.

The FDA extended its review of Capricor's deramiocel with a refined indication, while a pain drug startup co-founded by Vivek Ramaswamy takes a fast path to pub

Turkish regulators are investigating Teva for allegedly manipulating the patent system and making disparaging claims about competitor drugs.

Senators say RFK Jr.'s explanation of how he disposed of a Gardasil litigation stake conflicts with his earlier answers.

Some public comments on a proposed OMB rule governing research funding have disappeared from a government webpage, raising transparency concerns.

The cell therapy manufacturing specialist is restructuring after an unnamed big pharmaceutical customer ended its contract.

New AI tools can flag diversion of controlled substances by hospital staff, but the systems are not foolproof without proper human follow-through.

Venture investment in women's health startups fell last year, though a broader definition and AI adoption could revive interest.