Latest Biotech News

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...

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...