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UniQureâs planned third-quarter submission for its Huntingtonâs disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantasâbut how long will it last? And how can companies be sure these positive decisions wonât just be reversed?
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While agents like AbbVieâs Humira have transformed the treatment landscape, not all patients benefit equally from the drug. Better biomarker analysis and more investment in mechanistic trials can inform the development of more effective therapies with broader clinical value.
Precision science is ruling the M&A scene as pharmas prepare for loss of exclusivity on key products, PwC says in a new report. Biotechs should be prepared with a dual-track process with the IPO window now open.
While biopharmaâs overarching mission is to develop innovative medicines to improve patient outcomes, for these six people, the motivation came from much closer to home.
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FDA veteran Peter Marks will now shape the future of Eli Lillyâs vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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Alto Neuroscience is advancing a depression drug based on the dopamine agonist pramipexole, which an independent study has found to help boost feelings of pleasure in patients with mood disorders.
With a one-time dosing profile, Intellia Therapeuticsâ gene editing asset could be âparadigm-shiftingâ for hereditary angioedema, according to Jefferies. The biotech anticipates market approval next year.
Neumora Therapeutics is laying off 35% of workers after its most advanced asset failed a pair of Phase 3 studies, sending the biotechâs stock spiraling early Monday.
Weeks after Boehringer Ingelheim and Eli Lilly retracted billions of dollar in German commitments, the nationâs government is reportedly changing a contentious element of its planned healthcare reforms.
Elicio Therapeuticsâ investigational cancer immunotherapy failed to meet the primary endpoint of disease-free survival in a Phase 2 trialâa result the company attributed mostly to a disproportionate number of patients with higher residual disease.
Sanofi makes no mention of the Commissionerâs National Priority Voucher. Tzield was awarded the ticket in October 2025, but Sanofi requested withdrawal from the program after former CDER head Tracy Beth Høeg reportedly expressed skepticism of the drug.
Rhythm Pharmaceuticalsâ Imcivree reduced fatâwhile boosting muscleâin patients with Prader-Willi syndrome.
Eli Lillyâs new JAK2 inhibitorâwhich it obtained from the recent acquisition of Ajax Therapeuticsâreduced spleen volume by more than a third in 70% of patients with myelofibrosis.
Intellia Therapeuticsâs Senior Vice President Maria Natale discusses why the most successful launches are shaped long before approval, with strategy, structure and patient insight at the core.
DemeRx is launching the first U.S. clinical trial of an ibogaine-derived drug candidate, marking a pivotal moment for a controversial psychedelic long sidelined by safety concerns.