Latest Biotech News

Freenome received US FDA breakthrough device designation for its blood-based SimpleScreen lung cancer screening assay, targeting adults ages 50 to 80 with at least a 20 pack-year history who are...

A physician-led group of experts in Prader-Willi syndrome notified clinicians about safety signals tied to Neurocrine Biosciences’ newly approved Vykat XR. The statement points to seven reported...

NeOnc Technologies reported Phase 2a results for intranasal NEO100 in recurrent IDH1-mutant high-grade glioma, saying the program met its primary endpoint for six-month progression-free survival....

Vaderis Therapeutics closed an oversubscribed $152 million Series B financing while simultaneously initiating HEROIC, its global Phase III study of engasertib (VAD-044) for hereditary hemorrhagic...

NeoGenomics detailed its expansion into NGS-based advanced oncology testing, leveraging a broader assay menu and community focus to differentiate in an increasingly crowded segment. Since the...

Metabolic-disease focused Vogenx priced an $81.3 million IPO to continue development of mizagliflozin, a gut-restricted SGLT1 inhibitor. The lead program is in development for post-bariatric...

Skylark Bio began a new gene therapy trial for hearing restoration, dosing a first patient in a GJB2-targeted program aimed at restoring hearing in a child with a mutation in the gap junction...

Ribox Therapeutics received FDA IND clearance for RXIM-002, an in vivo CAR-T therapy built around circular RNA and delivered via targeted lipid nanoparticles. The company plans to initiate a Phase...

Tufts Center for the Study of Drug Development reported a large financial uplift from Medable’s agentic AI clinical monitoring tool, quantifying improvements using expected net present value...

Caribou Biosciences outlined its plan to widen access to allogeneic CAR T therapies, moving toward a pivotal Phase III study. The company said its allogeneic approach has shown durability...

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...