Latest Biotech News

UniQure warned investors that the FDA’s recent feedback on its Huntington’s disease gene therapy will likely delay an anticipated approval filing and complicate its regulatory path. The company...

Natera acquired Foresight Diagnostics for $275 million upfront plus up to $175 million in milestones to integrate high-sensitivity phased-variant ctDNA technology into its Signatera minimal...

Triana Biomedicines closed an oversubscribed $120 million Series B to advance its molecular-glue degrader platform and push lead candidate TRI-611 toward the clinic for ALK-driven non–small-cell...

OTR Therapeutics, a Shanghai-based biotech, closed a $100 million Series A to build a diversified R&D and asset portfolio, with participation from Pfizer Ventures. The company said it will combine...

Illumina announced plans to expand beyond reagents and instruments by offering curated, high-value genomic datasets and analytics to pharmaceutical partners through a new BioInsight unit. The...

Newcastle startup Invenirex closed a £2 million seed round to commercialize an enzyme‑free nucleic acid detection platform built around programmable DNA microstructures dubbed 'nanites.' The...

FDA leadership shifted again this week as Richard Pazdur filed retirement paperwork after a brief tenure and Tracy Beth Høeg, a Makary deputy and vaccine-safety investigator, was named acting...

CBER director Vinay Prasad publicly defended his proposed vaccine-policy changes at a closed-door investor forum, blaming "misleading media narratives" for the escalation of criticism. His remarks...

The CDC’s Advisory Committee on Immunization Practices (ACIP) adjourned without resolving whether the universal newborn hepatitis B birth dose recommendation should be changed, delaying a...

Capricor Therapeutics reported top-line Phase III results for deramiocel in Duchenne muscular dystrophy that met both the primary upper-limb functional endpoint and a key cardiac secondary...

Novo Nordisk’s oral semaglutide failed to demonstrate a slowing of cognitive decline in the Evoke and Evoke+ Phase III programs, according to topline results presented at CTAD and company...

Triana Biomedicines closed a $120 million Series B financing to advance its molecular glue degrader platform and push lead candidate TRI-611 into clinical development for ALK-driven non–small cell...

A German regional court granted Halozyme a preliminary injunction ordering Merck to halt distribution of subcutaneous Keytruda (pembrolizumab SC) in Germany, advancing a broader patent dispute...

Researchers published a Nature Biotechnology report describing envelope-engineered virus‑like particles (VLPs) capable of delivering gene‑editing cargo to human hematopoietic stem and progenitor...

An international consortium released NeuMap, a single‑cell transcriptional atlas of neutrophils analyzing more than one million cells across 47 conditions and multiple tissues, published in...

Terray Therapeutics announced it reached its first discovery milestone under a multi‑target collaboration with Bristol Myers Squibb, validating its Experimentation Meets Machine Intelligence...

Capricor reported positive topline results from the pivotal Phase 3 HOPE-3 trial of deramiocel in Duchenne muscular dystrophy (DMD), hitting both its primary muscle endpoint and a key cardiac...

The FDA appointed Tracey Beth Høeg as acting director of the Center for Drug Evaluation and Research (CDER), continuing rapid turnover at the agency’s senior ranks. Høeg, who served as a special...

Tensions over vaccine policy intensified as Vinay Prasad, the FDA’s top vaccines regulator, defended proposed changes while a group of former FDA commissioners publicly criticized his plans....

Data presented at the Clinical Trials on Alzheimer’s Disease (CTAD) 2025 meeting confirmed that oral semaglutide did not slow cognitive decline in the Evoke and Evoke+ phase III trials, reversing...