Latest Biotech News

Lisen Imprinting Diagnostics is working with ChristianaCare to clinically validate its lung cancer detection assay, built around quantifying “loss of imprinting” in ambiguous biopsy cases. The...

Taiho Oncology and Cullinan Therapeutics said their EGFR inhibitor zipalertinib cleared a Phase 3 registrational test in the front-line setting for a genetically defined lung cancer population....

Freenome received FDA breakthrough device designation for its blood-based SimpleScreen lung cancer screening assay. The designation covers the assay’s proposed use in adults ages 50 to 80 with at...

PTC Therapeutics won an auction-stage deal to acquire portions of bankrupt Sangamo Therapeutics, including Sangamo’s Fabry disease program, for up to $264 million. The transaction structure...

Vaderis Therapeutics closed an oversubscribed $152 million Series B financing and launched its global Phase III study HEROIC in hereditary hemorrhagic telangiectasia (HHT). The trial evaluates...

Tufts Center for the Study of Drug Development (CSDD) and Medable reported an eNPV-based analysis indicating Medable’s AI clinical monitoring agent can generate net financial gains of up to $21...

Vogenx Inc. priced an $81.3 million IPO aimed at funding continued development of mizagliflozin, its SGLT1 inhibitor in metabolic disease. The company said the drug is in development for...

N6 Tec expanded distribution for its IconPCR instruments and AutoNorm intelligent normalization technology across Europe, the Middle East, and Africa. The company said it extended its partnership...

China’s gene-editing landscape faced another safety setback as Huidagene Therapeutics disclosed the death of a boy receiving HG-302 gene editing for Duchenne muscular dystrophy (DMD). The...

FDA issued a complete response letter (CRL) to ITM Isotope Technologies Munich SE for its radiotherapeutic ITM-11 (177Lu-edotreotide) intended to treat gastroenteropancreatic neuroendocrine tumors...

FDA approved Takeda’s oral orexin receptor 2 agonist Orzeyful (oveporexton) for adult narcolepsy type 1, marking a first-in-class therapy targeting the underlying cause. The approval came Aug. 5...

Definium Therapeutics reported late-stage progress for DT-120 (lysergide) in generalized anxiety disorder, clearing the bar in the first of two Phase III trials. The update follows recent Phase...

Teledyne agreed to acquire Varex Imaging in a deal valued at about $1.1 billion, extending Teledyne’s push deeper into medical imaging. The move reflects continued consolidation across...

Vogenx priced an $81.3 million IPO to fund continued development of mizagliflozin, a metabolic-disease candidate in development for post-bariatric hypoglycemia, gastroparesis, and GIP-dependent...

Experts on Prader-Willi syndrome sounded the alarm over safety signals possibly linked to Neurocrine Biosciences’ Vykat XR, after reports of deaths and serious adverse events. The experts noted...

Amprion and MLM Therapeutics expanded the availability of a key prostate alpha-synuclein diagnostic by licensing the seed amplification assay technology behind Amprion’s SAAmplify-αSYN test to...

The US federal government advanced a two-track update to 340B drug pricing oversight, targeting how covered entities handle and report reimbursement flows. CMS proposed changes to payment rates...

A new analysis calls for EMT training to support decentralized clinical trials, arguing that cross-trained mobile clinicians could scale field-based assessments and safety monitoring. The work,...

Tufts Center for the Study of Drug Development modeled Medable’s agentic AI clinical monitoring platform and estimated large financial upside across oncology programs. The analysis reported...

Caribou Biosciences is preparing to widen access to allogeneic CAR T by moving toward a pivotal Phase III trial, supported by its genome editing approach and product optimization. The company said...