Latest Biotech News

The FDA approved an expanded companion diagnostic label for Foundation Medicine’s FoundationOne CDx to support EMD Serono’s Tepmetko (tepotinib) in metastatic NSCLC with MET exon 14 skipping...

The FDA approved Guardant Health’s upgraded Guardant360 Liquid CDx, expanding blood-based tumor profiling to a much larger genomic footprint for cancer treatment decision-making. Guardant said...

US lawmakers introduced a bill to update CLIA oversight for laboratory-developed tests, aiming to restore more structured governance following a 2025 court decision that positioned LDTs as...

Bristol Myers Squibb expanded its enterprise AI strategy by partnering with Anthropic to deploy Claude across global operations, aiming to move beyond chat-only use cases. The collaboration will...

CAR T manufacturing and development continued to progress through early regulatory and deal announcements spanning autoimmune targeting and next-generation bivalent antigen designs. Hangzhou...

Beyond primary weight-loss efficacy, companies are increasingly using cardiometabolic risk-factor readouts and broader endpoint coverage to support obesity drug value propositions. Coverage of...

Biotech financing and M&A activity continued to accelerate through high-value deals and public-market bids aimed at extending clinical programs. Parabilis Medicines filed for an IPO while...

Across development platforms and enabling technologies, new investments and product roadmaps are focusing on scaling data capture, manufacturing flexibility, and agentic support for drug...

Eli Lilly’s next-generation triple-acting obesity drug retatrutide cleared another major milestone in Phase 3, with “TRIUMPH-1” data showing sustained weight loss over 80 weeks. At the highest 12...

A second report on retatrutide reframed the Phase 3 “TRIUMPH-1” dataset as a competitiveness test against both Lilly’s existing GLP-1/GIP product Zepbound and the broader market leaders. The new...

Immunovant’s shares jumped after early, open-label “compelling” Phase 2b data for IMVT-1402 in difficult-to-treat rheumatoid arthritis. The program enrolled patients who had already failed at...

BioMarin moved to expand Voxzogo after new clinical results supporting use in children with hypochondroplasia, a skeletal disorder related to achondroplasia. In a Phase 3 trial, participants...

The FDA approved Guardant Health’s upgraded Guardant360 Liquid CDx, expanding the test’s genomic and epigenomic coverage for comprehensive tumor profiling from a single blood draw. The new assay...

Bristol Myers Squibb partnered with Anthropic to deploy Claude AI across global operations, aiming to accelerate drug discovery and development through enterprise-wide integration. The platform is...

CMS expanded Medicare coverage for Personalis’ NeXT Personal minimal residual disease test to include monitoring response to neoadjuvant therapies in stage II to III triple-negative or...

Liminatus Pharma agreed to acquire InnocsAI in a share-based deal valued at about $320 million, positioning the purchase around InnocsAI’s autologous CD19xCD22 bivalent CAR-T platform IBC101. The...

Eli Lilly agreed to acquire Engage Biologics for $202 million, adding preclinical non-viral DNA delivery technology to its genetic medicines pipeline. The deal centers on Engage’s Tethosome...

Hangzhou Qihan Biotech received IND clearance from the FDA for QT-019C, a universal allogeneic CAR-T therapy targeting autoimmune diseases. The off-the-shelf program is engineered from healthy...

Guardant Health won FDA approval for an upgraded Guardant360 Liquid CDx, positioning the test to expand comprehensive tumor profiling beyond the company’s prior assay footprint. Guardant said the...

Liminatus Pharma agreed to pay shares worth $320 million to acquire InnocsAI, adding an early CAR-T pipeline including IBC101, an autologous CD19xCD22 bivalent program targeting relapsed or...