Latest Biotech News

The FDA proposed new steps intended to cut the time needed to start first-in-human trials, using a budget-driven regulatory pathway approach. The plan would introduce an optional, risk-based...

Regulators’ enforcement focus on patient support programs (PAPs) intensified, with DOJ and OIG scrutiny centered on compliance gaps tied to program design, intent, and profit-driven outcomes. At...

Grail and Epic announced a collaboration that will integrate the Galleri multi-cancer early detection test directly into Epic electronic health record workflows. Clinicians using Epic will be able...

Amplia Therapeutics halted recruitment in its Phase II Amplicity trial in advanced pancreatic cancer after three dose-limiting toxicities linked to the chemotherapy backbone combined with...

South Korea rolled out regulatory changes designed to speed biosimilar development, including shorter review timelines, eased Phase III trial requirements, and simplified oversight of...

Blackstone and TPG completed their acquisition of Hologic, moving the molecular diagnostics and medical technology company to the private markets. The deal, valued at up to $18.3 billion, takes...

Zymo Research partnered with Stori to commercialize a cfDNA-based early pregnancy test built around Zymo’s sample preservation and cfDNA extraction technologies. The companies said the test can...

AbbVie agreed to offer Humira through the government direct-to-consumer platform TrumpRx at around $950 per month, alongside other discounted AbbVie products, in the context of tariff and...

Gilead Sciences agreed to acquire German antibody-drug conjugate specialist Tubulis in a deal valued at up to $5 billion, with $3.15 billion upfront and as much as $1.85 billion in milestones. The...

Neurocrine Biosciences agreed to acquire Soleno Therapeutics for $2.9 billion to bolster its foothold in endocrinology and rare disease. The companies said Neurocrine will pay $53 per share in...

The FDA outlined proposals in its 2027 budget to encourage domestic drug development and manufacturing, including a plan to make it easier for companies to start early clinical testing in the U.S....

The FDA is seeking to cut time to first-in-human studies through a new regulatory pathway described as optional and risk-based. The proposal is intended for experimental drugs with existing...

South Korea announced regulatory changes designed to shorten biosimilar review timelines and streamline oversight of manufacturing changes. The reforms also aim to reduce the phase III trial...

Grail and Epic announced a collaboration to integrate the Galleri multi-cancer early detection test into Epic electronic health record platforms. Clinicians using Epic will be able to access the...

CellCarta and Lunit entered a partnership to integrate Lunit’s AI pathology tools (Scope) with CellCarta’s clinical trial pathology services. The companies said the combined offering will support...

Bristol Myers Squibb said it will use AI with Faro Health to streamline clinical trial protocol development using structured design tools. Under the multiyear agreement, Faro’s technology converts...

Regulators increased focus on compliance gaps in patient support programs (PAPs), with DOJ and OIG scrutiny tied to program design intent and profit orientation. Coverage from Access USA...

Multiple biopharma companies announced leadership changes in legal and compliance functions, reflecting continued emphasis on governance as commercial footprints expand. Aquestive Therapeutics...

Gilead Sciences agreed to acquire German biotech Tubulis in a deal valued at up to $5 billion, expanding Gilead’s antibody–drug conjugate (ADC) pipeline with new linker and payload technologies....

Neurocrine Biosciences agreed to acquire Soleno Therapeutics for $2.9 billion, adding Soleno’s marketed Prader-Willi syndrome therapy Vykat XR to Neurocrine’s endocrinology and rare disease...