Latest Biotech News

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

A federal judge in Maine issued a temporary restraining order blocking the Health Resources and Services Administration’s 340B Rebate Model pilot that would have let manufacturers offer rebates...

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

Hutchmed announced that China’s NMPA accepted the NDA for fanregratinib (HMPL‑453), an FGFR‑targeted therapy, and granted the submission priority review for intrahepatic cholangiocarcinoma. The...

Sanofi added hepatitis B vaccine and a shingles clinical candidate to its vaccine portfolio through the acquisition of select Dynavax assets, the companies reported. The deal broadens Sanofi’s...

Insilico Medicine closed a Hong Kong initial public offering, raising gross proceeds that position the AI‑drug discovery company for expanded platform development and clinical advancement. The...

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...