Latest Biotech News

The FDA cleared Vera Therapeutics’ Trutakna (atacicept) as the first dual BAFF/APRIL inhibitor for immunoglobulin A nephropathy (IgAN), marking a new accelerated-approval milestone in kidney...

Vertex Pharmaceuticals agreed to acquire Crinetics Pharmaceuticals for about $10 billion, its largest-ever deal, in a move to broaden beyond cystic fibrosis into specialty endocrinology. The...

Novartis agreed to buy Myricx Bio for up to $1.5 billion to add a next-generation antibody-drug conjugate (ADC) payload platform to its oncology pipeline. The London-based company is developing...

A cluster of rare-disease acquisitions surfaced as biopharma M&A activity ramped into the second half of the year. Deal coverage highlighted proposed takeouts including Vertex’s bid for Crinetics,...

AstraZeneca struck a licensing transaction with Sino Biopharmaceutical for ex-China rights to a late-phase COPD challenger targeting chronic obstructive pulmonary disease, stepping up its...

In an ultra-rare disease regulatory adjustment, the FDA cleared Saol to resubmit its NDA after dropping a requirement for a new trial. The decision effectively changes the resubmission pathway for...

New research flagged a specific “target-high but uptake-defective” state that can drive resistance to ADCs, with attention centered on Padcev (enfortumab vedotin). The work suggests that beyond...

Biocartis and Discovery Life Sciences launched a strategic collaboration to provide faster precision oncology biomarker testing and clinical trial assay support. The deal combines Discovery’s...

Swedish startup Aligned Bio is advancing a nanowire-based approach to convert sequencing-by-synthesis (SBS) instruments into single-molecule sequencers. The company presented proof-of-concept data...

Opus Genetics said it secured U.S. FDA alignment on an eight-patient Phase III trial of its gene therapy OPGx-LCA5 for an ultra-rare inherited childhood blindness indication. The regulatory...

Vera Therapeutics won an FDA accelerated approval for Trutakna (atacicept) to treat adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. The agency cleared the...

Vertex Pharmaceuticals announced a $10 billion cash acquisition of Crinetics Pharmaceuticals, its biggest-ever deal, designed to extend Vertex beyond cystic fibrosis into a broader endocrinology...

Novartis agreed to acquire Myricx Bio for up to $1.5 billion, adding a next-generation antibody-drug conjugate (ADC) payload platform to bolster its oncology pipeline. The deal is centered on...

Tvardi Therapeutics reported Phase I data for TTI-109, a next-generation oral STAT3 inhibitor built as a phosphate prodrug of TTI-101. The company said the program rebounded after the earlier...

Compass Pathways said patients in the second of its two pivotal psilocybin trials maintained their treatment response for at least six months, supporting durability ahead of an expected year-end...

Researchers published findings identifying a potential ADC resistance mechanism described as a “target-high but uptake-defective” state, drawing attention to how internalization defects can limit...

Oberland Capital agreed to provide up to $400 million into MeiraGTx to push multiple gene therapy prospects toward commercialization. The funding deal is framed as confidence in MeiraGTx’s...

Opus Genetics announced U.S. FDA alignment on an eight-patient Phase III trial for OPGx-LCA5, its lead gene therapy targeting an ultra-rare inherited childhood blindness condition. The company...

Biocartis and Discovery Life Sciences entered a strategic collaboration to expand access to rapid biomarker testing for precision oncology and clinical trial enrollment. The partnership combines...

EY said AI-driven supply chain orchestration could address persistent clinical trial distribution and complexity challenges, especially for advanced modalities such as monoclonal antibodies and...