Latest Biotech News

The FDA issued a CRL for ITM Isotope’s ITM-11 (177Lu-edotreotide) for gastroenteropancreatic neuroendocrine tumors, citing manufacturing issues at a third-party facility rather than concerns about...

Eli Lilly moved to shut down a growing “black market” for retatrutide, filing the first lawsuits targeting six U.S. sellers. The company alleges the businesses are offering illegal versions of its...

Vogenx priced an $81.3 million IPO to fund continued development of mizagliflozin, a glucose control SGLT1 inhibitor in programs spanning post-bariatric hypoglycemia, gastroparesis, and...

NeOnc Technologies delivered top-line Phase 2a data for intranasal NEO100 in recurrent IDH1-mutant high-grade glioma, reporting a six-month progression-free survival of 48.9% versus a...

Freenome received FDA Breakthrough Device Designation for its blood-based SimpleScreen lung cancer screening assay. The multiomic test combines a machine-learning classifier using DNA methylation...

Boulevard Bio launched from stealth with $65 million in funding led by Deerfield Management, positioning the company to develop targeted autoimmune immunotherapies built around immune reset...

Innate Pharma secured a large Sobi partnership for lacutamab in cutaneous T-cell lymphoma, including Sézary syndrome, in a deal structured around development milestones and an option for Sobi to...

July’s FDA approvals marked the first products for three biotechs, including Vera Therapeutics’ accelerated approval for Trutakna atacicept in primary immunoglobulin A nephropathy. Celcuity plans...

Tufts Center for the Study of Drug Development estimated that an agentic AI clinical monitoring tool from Medable can deliver outsized value in oncology trials, modeling net financial gains up to...

A large review described obesity as a systemic driver of cellular stress, linking overnutrition to unfolded protein response and oxidative and inflammatory signaling pathways, including NRF2. The...

Eli Lilly took its first major enforcement step against the “black market” for retatrutide by filing lawsuits targeting six U.S. companies, alleging they sold unauthorized versions of the...

Freenome won an FDA Breakthrough Device Designation for its blood-based SimpleScreen lung cancer screening assay, aimed at adults ages 50 to 80 with a 20 pack-year smoking history who are not...

Caribou Biosciences moved to widen access to its allogeneic CAR T programs by preparing for a pivotal Phase III trial, citing engineered genome-editing strategies and product optimization. The...

Tufts Center for the Study of Drug Development reported that an AI clinical monitoring agent could generate up to 82 times return on investment (ROI) in oncology trials, using expected net present...

Vaderis Therapeutics closed an oversubscribed $152 million Series B financing and simultaneously initiated HEROIC, its global Phase III study of engasertib (ALM 301) in hereditary hemorrhagic...

Definium Therapeutics reported positive top-line results from a late-stage Phase III trial of its oral LSD candidate, DT-120 (lysergide), in generalized anxiety disorder. The company said the...

Ribox Therapeutics received FDA IND clearance for RXIM-002, a circular RNA (circRNA)-based in vivo CAR-T program delivered via a targeted lipid nanoparticle (tLNP). The company plans to run a...

Natera and Kupando Therapeutics launched a Phase I collaboration in Germany that will use Natera’s blood-based Latitude circulating tumor DNA (ctDNA) assay to monitor treatment response in skin...

Physicians and experts on Prader-Willi syndrome issued new safety warnings about Neurocrine Biosciences’ newly approved Vykat XR. The experts said Vykat XR has been linked to seven deaths and more...

In parallel with AI-driven efficiency claims for clinical trial monitoring, U.S. policymakers are pushing faster first-in-human trial execution through regulatory modernization initiatives,...