Latest Biotech News

Eli Lilly’s once-weekly basal insulin pen, Onswik, received FDA approval for patients with type 2 diabetes, setting up direct competition with Novo Nordisk. Lilly positioned the therapy as a...

Merck’s ophthalmology effort tied to its $1.3 billion upfront acquisition of EyeBio has hit a pivotal milestone, according to the company’s first reported success. The development suggests the...

Kyverna Therapeutics reported one-year data supporting its autoimmune CAR-T submission for stiff person syndrome, with the company presenting long-term autoimmune benefit in the ongoing...

Acadia Pharmaceuticals reported a Phase 2 failure in Alzheimer’s disease psychosis but said the company has enough signal to continue into Phase 3 with modifications. The company framed the...

Boehringer Ingelheim and AbbVie executives discussed why deal signing often comes only after value creation work begins, emphasizing structure, risk alignment, and early scientific diligence. In a...

Roche has secured two separate discovery partnerships with Atavistik Bio and Earendil Labs, expanding its pipeline of new candidates through continued dealmaking in discovery-stage development....

Enveda raised $311 million in a Series E to expand its nature-derived AI drug discovery pipeline, with three programs currently in human testing. The startup said ENV-294 and ENV-308 have shown...

An FDA advisory panel endorsed Grail’s Galleri blood test for multiple cancers after voting that benefits outweigh risks, marking an important step for early detection of disease before symptoms...

Sarepta Therapeutics agreed to pay Regenxbio $39 million to settle gene therapy claims, according to the update provided alongside other biotech business items. The settlement indicates continued...

AI-native drug discovery is accelerating on multiple fronts, with fresh capital backing companies that combine generative chemistry models, large biological data resources, and automation....

An FDA advisory panel backed Grail’s Galleri multi-cancer early detection blood test, concluding the benefits outweigh risks for patients meeting the proposed indication criteria. The panel voted...

Roche reported positive interim Phase 3 results for sefaxersen (formerly IONIS-FB-LRx), positioning the antisense oligonucleotide candidate for a potential accelerated path in IgA nephropathy. The...

Kyverna Therapeutics released one-year clinical data intended to support an FDA submission for its rare autoimmune CAR-T candidate miv-cel (miv-cel), in stiff person syndrome. The company reported...

Iambic Therapeutics filed for a Nasdaq IPO, aiming to bring its AI-powered, robotics-enabled oncology drug discovery platform to public markets. The San Diego-based company plans to list under the...

Eli Lilly signed a new China-focused partnership with Beijing-based InnoCare, a deal that could reach up to $3.35 billion if products reach the market. Lilly will provide upfront funding and...

Amicus Therapeutics CEO Bradley Campbell is set to succeed Eric Dube as President and CEO of Travere Therapeutics, effective Dec. 1. The leadership change reflects the end of Dube’s eight-year...

Immunovant stopped development of IMVT-1402 (imeroprubart) in cutaneous lupus erythematosus after failing to meet a midphase endpoint in the program. The decision closes one potential path to...

Roivant reported a Phase 2b failure for IMVT-1402 (imeroprubart) in a form of lupus, stating the program did not improve symptoms. The result adds another cautionary datapoint for FcRn biology in...

Merck’s Brunello trial hit its primary endpoint for a trispecific diabetic macular edema (DME) program, reflecting clinical benefit for the drug candidate acquired in a $3 billion transaction. The...

Kyverna Therapeutics disclosed 1-year follow-up data for miv-cel in stiff person syndrome, aiming to strengthen its FDA submission in the rare autoimmune CAR-T space. The company said the updated...