Latest Biotech News

The U.S. and U.K. reached an agreement that exempts British-origin pharmaceuticals from U.S. tariffs for three years in return for pricing concessions and higher UK spending on medicines. The deal...

Recipharm Advanced Bio and Infant Bacterial Therapeutics (IBT) initiated a process performance qualification (PPQ) at Recipharm’s Cuxhaven microbial manufacturing site to validate commercial...

Precision Health Research, Singapore (PRECISE) announced a precompetitive collaboration with Alnylam, Bayer, Boehringer Ingelheim and Novo Nordisk to analyze data from the PRECISE‑SG100K...

Generate:Biomedicines announced the initiation of Phase 3 clinical studies for its lead TSLP (thymic stromal lymphopoietin) antibody, moving the AI-enabled discovery company’s lead program into...

Q32 Bio sold rights to its Phase II complement inhibitor ADX‑097 to Akebia Therapeutics for $12 million upfront, with up to $592 million in potential milestones, extending Q32’s cash runway and...

Researchers and companies presented advances in allogeneic CAR T approaches designed to reduce off‑target CRISPR risks (CRAFT CAR T) and to extend CAR T therapy into central nervous system (CNS)...

Regeneron entered a global collaboration with Tessera Therapeutics to co-develop TSRA-196, a near-clinic in vivo gene-writing candidate for alpha-1 antitrypsin deficiency (AATD). The deal includes...

Belite Bio reported positive topline results from the Phase 3 DRAGON trial of tinlarebant in adolescents with Stargardt disease type 1, meeting the primary endpoint with a clinically meaningful...

Protego Biopharma closed an oversubscribed $130 million Series B to advance PROT‑001, its oral candidate for AL (light‑chain) amyloidosis, toward a pivotal study. The financing was led by...

Federal vaccine policy is in flux after internal CBER memos and agency planning signalled a stricter evidentiary bar for vaccine approvals, prompting public debate and scrutiny. FDA leadership has...

Lundbeck withdrew from a bidding contest for Avadel Pharmaceuticals, locking in Alkermes’ path to acquire the sleep‑disorder drug developer under a roughly $2.37 billion bid that includes...

Q32 Bio sold rights to its phase II complement inhibitor ADX‑097 to Akebia Therapeutics, generating upfront proceeds that materially extend Q32’s cash runway and let the small developer focus...

The U.K. agreed to relax certain drug‑pricing rules and increase spending on medicines in exchange for a U.S. decision not to impose tariffs on British‑origin pharmaceuticals, ingredients and...

Janux Therapeutics released a new data cut from an ongoing Phase 1 study of JANX007, a T‑cell engager for metastatic castration‑resistant prostate cancer, showing response rates around 30% in the...

Recursion announced a planned leadership transition: long‑time CEO Chris Gibson will become board chair and Najat Khan, PhD, the company’s chief R&D and commercial officer, will assume CEO...

Researchers at the University of Duisburg‑Essen developed an automated stirred‑tank bioreactor process to generate large quantities of iPSC‑derived lung organoids, producing complex...

Regeneron Pharmaceuticals struck a $150 million collaboration with Tessera Therapeutics to develop and commercialize TSRA-196, a near-clinic in vivo gene-writing candidate for alpha-1 antitrypsin...

Protego Biopharma closed a $130 million oversubscribed Series B led by Novartis Venture Fund and Forbion to advance its first-in-class oral program for light‑chain (AL) amyloidosis into a...

Belite Bio reported topline success from its 104-subject Phase 3 DRAGON trial: tinlarebant produced a statistically significant 36% reduction in the growth rate of retinal lesions versus placebo...

The FDA approved Novartis’ intrathecally delivered SMA gene therapy Itvisma (onasemnogene abeparvovec), offering a new delivery route intended to broaden access beyond the intravenous label of...