Latest Biotech News

Dyne Therapeutics reported a positive pivotal trial in Duchenne muscular dystrophy, meeting the study’s primary endpoint and positioning the company to seek accelerated approval from the FDA. The...

The FDA’s Center for Biologics Evaluation and Research signaled a major policy shift: randomized controlled trials (RCTs) will generally be required to support approvals of CAR‑T cancer therapies,...

Late‑breaker data from the Majestec‑3 trial presented at ASH showed the teclistamab plus daratumumab combo produced an unprecedented progression‑free survival (PFS) benefit in relapsed/refractory...

Eli Lilly selected Huntsville, Alabama, as the site for a $6 billion active pharmaceutical ingredient (API) facility that will produce peptide and small‑molecule APIs, including the oral GLP‑1...

Mirum Pharmaceuticals agreed to acquire Bluejay Therapeutics in a deal that brings brelovitug, a late‑stage monoclonal antibody for chronic hepatitis D (HDV), into Mirum’s rare liver disease...

Pfizer continued its aggressive buildout of oral GLP‑1 candidates, signing licensing deals with Chinese developers that give the pharma global rights to small‑molecule obesity therapies. One...

Structure Therapeutics released Phase IIb data showing its oral GLP‑1 candidate, aleniglipron, produced placebo‑adjusted weight loss up to ~15% and delivered strong iterative readouts across...

Insilico Medicine reported the AI‑driven discovery of a bifunctional PROTAC degrader targeting PKMYT1, a kinase implicated in cell‑cycle control and synthetic‑lethality vulnerabilities. Using its...

ARPA‑H awarded up to $31.7 million to a multi‑partner consortium led by Ginkgo Bioworks and AI discovery firm Deep Origin to develop non‑animal computational and ex‑vivo systems for drug safety...

The FDA proposed a user‑fee scheme that would raise application fees for development programs conducting Phase I trials outside the U.S. under ongoing PDUFA negotiations. The agency said higher...

Radboud University Medical Center began running long‑read whole‑genome sequencing (WGS) as a frontline diagnostic for genetic eye disease and severe intellectual disability, replacing multiple...

Eli Lilly selected Huntsville, Alabama as the site for a $6 billion active pharmaceutical ingredient (API) facility that will produce peptide and small‑molecule APIs including its oral GLP‑1...

Delix Therapeutics reported positive Phase Ib efficacy and biomarker data for zalsupindole (DLX‑001), a non‑hallucinogenic oral neuroplastogen, in adults with major depressive disorder (MDD). The...

Dyne Therapeutics announced that its Duchenne muscular dystrophy (DMD) exon‑51 candidate met primary endpoints in a pivotal/registrational study and plans to pursue an accelerated FDA filing. The...

Late‑breaking data from the Majestec‑3 trial presented at ASH show that the combination of teclistamab (a BCMAxCD3 bispecific) plus daratumumab produced an 83.4% three‑year progression‑free...

Mirum Pharmaceuticals announced an acquisition of Bluejay Therapeutics for roughly $620 million in cash and stock to secure brelovitug, a late‑stage monoclonal antibody with Phase II data showing...

Insilico Medicine reported the discovery of an AI‑designed PROTAC degrader, D16‑M1P2, targeting PKMYT1, a kinase implicated in cell‑cycle control and synthetic‑lethality vulnerabilities in certain...

Radboud University Medical Center in the Netherlands began offering frontline diagnostic whole‑genome sequencing (WGS) using Pacific Biosciences long‑read technology for genetic eye diseases and...

Researchers at UC San Diego and collaborators released the GNPS Drug Library, a publicly available MS/MS reference atlas of thousands of drugs, metabolites, and analogs to detect drug exposures...

The U.S. Food and Drug Administration proposed revisions to user‑fee structures that would raise fees for development programs that do not conduct Phase I trials in the U.S., a policy pitched as a...