Get the Daily Brief
Latest Biotech News
FDA accelerates early clinical development in U.S.
The FDA has outlined new budget-driven proposals aimed at shortening the path to first-in-human studies and shifting earlier development momentum back to the U.S., where industry critics say China...
Regulators weigh molecular-glue strategy in ALK-positive NSCLC
The FDA granted Fast Track designation to TRI-611 for ALK-positive non-small cell lung cancer, signaling regulatory interest in the program as an additional option after resistance to existing ALK...
Sanofi’s lunsekimig delivers in respiratory studies but misses eczema endpoint
Sanofi reported that its bispecific antibody drug lunsekimig (targeting TSLP and IL-13) doubled phase 2 respiratory wins while failing to improve atopic dermatitis severity in a separate phase 2...
Neurocrine to buy Soleno in $2.9B Prader-Willi hyperphagia deal
Neurocrine Biosciences agreed to acquire Soleno Therapeutics for $2.9 billion, adding Vykat XR (diazoxide choline) to its rare-disease portfolio and boosting its Prader-Willi syndrome exposure....
Amgen pushes injectable Tepezza data as competition nears
Amgen said its injectable version of Tepezza (teprotumumab) cleared a Phase 3 bar in thyroid eye disease, producing comparable efficacy to the infused version in a key study. The company’s updated...
AI moves into clinical protocol design at BMS via Faro Health
Bristol Myers Squibb partnered with Faro Health to use AI-driven structured design for clinical trial protocol development, according to company statements. The multiyear effort is intended to...
Oncology discovery startup Stipple raises $100M for ADC platform
Stipple Bio emerged from stealth with a $100 million Series A financing to advance STP-100, an antibody-drug conjugate targeting an undisclosed tumor antigen, and to scale its Pointillist...
Cell-free methylation test claims low-cost multi-disease screening potential
UCLA researchers reported progress on MethylScan, a low-cost blood test designed to simultaneously detect multiple cancers, liver disorders, and other organ abnormalities using circulating...
Whole-genome sequencing gains traction in routine cancer decision-making
Dutch researchers argued for incorporating whole-genome sequencing into routine cancer care, using real-world analysis to quantify actionable findings beyond standard targeted approaches. In a...
Digital health funding rebounds as investors concentrate bets
Digital health funding rebounded in Q1 2026, reaching $4 billion across 110 deals, according to Rock Health data cited by reporting. The surge was driven primarily by “megadeals,” continuing a...
Regulation and FDA pathway changes for early drug development
The FDA is proposing a new, optional, risk-based expedited Investigational New Drug pathway aimed at reducing time to first-in-human studies for drugs with adequate preclinical data. The plan is...
Biopharma tariffs and industrial policy reshaping drug economics
The Trump administration’s tariff policy for prescription drugs moved from proposal to implementation, imposing a 100% sector tariff on prescription drugs and associated ingredients. Timing begins...
M&A: Neurocrine’s $2.9B Soleno acquisition to expand Prader-Willi therapy
Neurocrine Biosciences announced it will buy Soleno Therapeutics for $2.9 billion to add Vykat XR (diazoxide choline) to its rare-disease portfolio. The deal price is $53 per share in cash,...
ADC and drug development setbacks: Lipocine’s rapid-onset postpartum depression miss and trial divergence
Lipocine added another clinical setback as its oral postpartum depression program failed to meet its primary endpoint in individuals with postpartum depression. BioCentury’s clinical report...
Oncology mechanism research: mitochondrial function and immune control in antitumor response
A St. Jude-led study in Science reports that tumors can suppress immune “gatekeeper” dendritic cells by reprogramming their mitochondrial metabolism. In preclinical mouse models, restoring...
Precision oncology diagnostics: whole-genome sequencing for routine cancer care
Dutch researchers argued in Nature Medicine that whole-genome sequencing (WGS) should move toward routine use in cancer care, either for biomarker-guided therapy selection or for clarifying tumor...
Rare disease and translational strategy: clinical and funding signals around new platforms
Researchers at Vanderbilt Center for Antibody Therapeutics entered an option agreement with Saravir Biopharma to develop human monoclonal antibodies designed to treat and prevent measles...
Oncology drug delivery innovation: 3D-printed carriers for tumor-local drug release
University of Mississippi researchers reported a 3D-printed spanlastic drug-delivery approach targeting tumors with localized anticancer dosing. The strategy combines nanotechnology with additive...
Clinical trial design and data platforms: AI-structured protocol development at BMS
Bristol Myers Squibb said it is partnering with Faro Health to use AI for clinical trial protocol design. The multiyear effort is intended to accelerate study design and drafting by converting...
Funding and corporate buildout: Stipple emerges with $100M for antibody-drug conjugate target discovery
Stipple Bio raised $100 million in a Series A to advance STP-100, an antibody-drug conjugate (ADC) targeting an undisclosed antigen, and to expand its Pointillist discovery platform for precision...