Latest Biotech News

Late‑stage trials of setrusumab, an antibody intended to treat brittle‑bone disease (osteogenesis imperfecta), failed to meet primary endpoints, sending Ultragenyx and Mereo shares sharply lower...

Genmab announced the termination of clinical development for acasunlimab, a bispecific antibody previously advanced with BioNTech, citing strategic reprioritization after the partner withdrew. The...

The National Institutes of Health agreed to review hundreds of grant applications that had been paused under administration directives restricting research on diversity‑related topics. The...

Nido Biosciences announced it will wind down operations after Phase 2 results for its lead program fell short of expectations. The Boston‑area biotech’s closure underscores the high attrition risk...

The U.S. National Institutes of Health agreed to resume scientific review of hundreds of grant applications that had been paused under new administration directives, after litigation by science...

A federal judge in Maine issued a temporary restraining order halting a planned 340B Rebate Model pilot that would have let drugmakers offer rebates in lieu of up-front discounts for drugs...

The U.S. Food and Drug Administration approved Omeros Corp.’s Yartemlea (narsoplimab) for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA), marking the first...

China’s National Medical Products Administration accepted Hutchmed’s new drug application for fanregratinib (HMPL‑453), an FGFR‑targeted therapy for intrahepatic cholangiocarcinoma, and granted...

Novartis expanded its biomedical research and drug‑development operations in India, positioning the country as a major global R&D hub for the Swiss pharmaceutical giant. Company officials said...

Insilico Medicine completed a Hong Kong initial public offering as the AI‑driven drug discovery firm went public after four years of attempted listings. The company, one of the pioneers in...

Biotech equities rallied into 2026 as the sector’s exchange‑traded fund XBI jumped on a wave of M&A announcements and easing rate expectations. Executives and investors are entering the JP Morgan...

Two late‑stage Phase III programs of the monoclonal antibody setrusumab failed to meet primary endpoints, leaving partners Mereo Biopharma and Ultragenyx reeling. Both companies reported negative...

Genmab announced termination of Phase 3 development for acasunlimab, a bispecific antibody previously co‑developed with BioNTech, after the program failed to meet strategic objectives. The...

Industry analyses and academic summaries characterize 2025 as a turning point for in‑vivo gene therapies, noting multiple clinical and preclinical advances that improved delivery, targeting and...

The U.S. Food and Drug Administration approved Omeros Corp.'s narsoplimab (Yartemlea) for hematopoietic stem cell transplant‑associated thrombotic microangiopathy (TA‑TMA), making it the first...

Two late‑stage trials of setrusumab failed primary endpoints, sending shares of developers Mereo BioPharma and Ultragenyx tumbling and prompting strategic reassessments. The partners reported that...

China’s National Medical Products Administration granted approval to Innovent Biologics for Tabosun (ipilimumab N01, IBI‑310) in combination with sintilimab as a neoadjuvant treatment for stage...

Hutchmed (China) Ltd. secured National Medical Products Administration acceptance and priority review for an NDA for fanregratinib (HMPL‑453), an FGFR‑targeted therapy for intrahepatic...

Insilico Medicine completed a Hong Kong initial public offering after multiple attempts, raising gross proceeds that signal investor appetite for AI‑driven drug discovery companies. The company is...

Private financings for life‑science tools and diagnostics fell 20% year‑over‑year in H2 2025, according to GenomeWeb/360Dx data, with total investment of $1.21 billion across 38 transactions. The...