Latest Biotech News

The FDA proposed a new risk-based pathway that would cut time to first-in-human trials, aiming to reduce regulatory burden and accelerate clinical development in the U.S. The plan would create an...

Grail partnered with Epic to integrate its Galleri multi-cancer early detection test into Epic’s electronic health record platforms. The collaboration would allow clinicians to access Galleri...

Blackstone and TPG completed their acquisition of Hologic, moving the molecular diagnostics company off public markets at a valuation described as up to $18.3 billion. Under the deal, Hologic...

AbbVie will offer Humira on the White House’s TrumpRx direct-to-consumer platform at a reported $950-per-month price, as the administration pairs discounted biosimilars with a tariff-avoidance...

Terns Pharmaceuticals accepted a deal with Merck that values the leukemia specialist at a level about 15% below an earlier bid, according to regulatory filings. The revised outcome comes amid...

Regulators and DOJ enforcement trends are increasingly focused on compliance gaps in patient support programs (PAPs), with scrutiny tied to program design, profit intent, and how federal dollars...

CellCarta partnered with AI developer Lunit to integrate Lunit’s Scope AI pathology platform into CellCarta’s clinical trial pathology services. The collaboration targets biomarker development,...

UCLA researchers developed MethylScan, a low-cost, single-sample blood test using targeted DNA methylation sequencing of cell-free DNA to detect multiple cancers and other conditions. In early...

Gilead Sciences moved deeper into antibody-drug conjugates by agreeing to buy German ADC specialist Tubulis in a deal structured around a $3.15 billion upfront payment and up to $1.85 billion in...

Merck lowered its bid for Terns Pharmaceuticals after receiving new clinical-data signals, underscoring how ADC and oncology deals are increasingly sensitive to real-world efficacy and safety...

The U.S. FDA is proposing new pathways aimed at cutting time to first-in-human studies, using the 2027 budget to support more streamlined trial entry for sponsors with adequate preclinical...

AbbVie agreed to sell Humira through the government’s TrumpRx direct-to-consumer platform at a reported 86% discount as the administration works to manage tariff threats and broader pricing...

Novo Nordisk launched a higher-dose version of Wegovy in the U.S., adding a 7.2 mg injection to its chronic weight management regimen. The product expansion focuses on patients requiring step-up...

Neurocrine Biosciences agreed to buy Soleno Therapeutics for $2.9 billion to obtain Vykat (diazoxide choline), its approved treatment for hyperphagia in Prader-Willi syndrome. Under the terms...

Sanofi reported mixed Phase 2 outcomes for lunsekimig, a bispecific nanobody targeting TSLP and IL-13, succeeding in asthma and chronic rhinosinusitis with nasal polyps but failing to meet primary...

Zymo Research and Stori entered a collaboration to commercialize an at-home cfDNA-based early pregnancy test built on Zymo’s sample preservation and cfDNA extraction chemistries. The test is...

OneCyte and Kemp Proteins expanded bioprocess and discovery tooling by partnering to combine OneCyte’s high-throughput single-cell analysis for clone selection with Kemp’s PROTiQ machine-learning...

Blackstone and TPG completed their acquisition of Hologic, taking the molecular diagnostics and women’s health company private in a transaction valued at up to $18.3 billion. Under the terms,...

The FDA is using the president’s 2027 budget proposal to outline new policies aimed at shortening the path to first-in-human studies and increasing U.S.-based drug development and manufacturing,...

Gilead Sciences agreed to buy German biotech Tubulis for $3.15 billion upfront, with up to $1.85 billion more tied to milestones, in a deal focused on next-generation antibody-drug conjugates...