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Moderna’s mRNA flu vaccine regulatory path clears FDA advisory committee
An FDA advisory panel voted unanimously to support Moderna’s seasonal mRNA influenza vaccine candidate, mRNA-1010, advancing the product’s regulatory turnaround. The Vaccines and Related...
Biopharma M&A: Biogen buys immunology startup RayThera for up to $1B
Biogen agreed to acquire RayThera in a deal valued at up to $1 billion, adding a suite of early-stage immunology-focused small-molecule candidates to its pipeline. RayThera’s investors will...
Antibiotics/anti-infectives: GSK-Spero oral antibiotic wins FDA approval for cUTI
The FDA approved Spero Therapeutics’ oral carbapenem antibiotic tebipenem pivoxil hydrobromide (branded Utebzi) for complicated urinary tract infections, including pyelonephritis. The approval...
Precision diagnostics: Diasorin obtains FDA clearance and CLIA waiver for rapid Group A Strep test
Diasorin received FDA 510(k) clearance and a CLIA waiver for a Group A streptococcus rapid molecular test on its Liaison Nes point-of-care PCR instrument. Diasorin said the assay delivers results...
FDA review and biodevice/clinical-genomics adoption: rapid nanopore CNS tumor classification rollout in Norway
Oxford Nanopore said Norway’s MATRIX program has begun rolling out a rapid nanopore sequencing assay for central nervous system (CNS) tumor classification across the country’s public healthcare...
Oncology pipeline: ADC Therapeutics Zynlonta faces trial-related fatal safety signal
ADC Therapeutics reported a stumbling block for its antibody-drug conjugate Zynlonta (loncastuximab tesirine) after Phase III results from LOTIS-5 showed higher fatal adverse events in the...
Biotech financing and go-to-clinic momentum: Prime Medicine gets NZ clearance for Wilson’s disease trial
Prime Medicine said New Zealand’s Medsafe cleared its clinical trial application for PM-577a, a Prime Editor for Wilson’s disease. The company positioned PM-577a as investigational and designed...
Regional regulatory frameworks for advanced therapies: China’s Order 818 opens a hospital-based pathway
China issued Order 818 establishing a new commercialization pathway for advanced therapeutic development, including cell and gene therapeutics and gene editing approaches. The regulation allows...
Biotech IPO/market access: Kardigan prices and upsizes $400M offering
Cardiovascular biotech Kardigan priced an upsized IPO to raise $400 million gross proceeds, following strong market demand for new listings. The company is offering 25 million shares at $16 per...
FDA OKs oral antibiotic Utebzi for complicated UTI
Spero Therapeutics’ oral carbapenem antibiotic tebipenem pivoxil hydrobromide, branded as Utebzi, has received US FDA approval for complicated urinary tract infections (cUTI), including...
FDA advisory committee backs Moderna’s mRNA flu vaccine
Moderna’s mRNA influenza vaccine mRNA-1010 moved back into regulators’ favor as FDA vaccine advisers voted unanimously that benefits outweigh risks. The Vaccines and Related Biological Products...
FDA clears Diasorin’s point-of-care group A strep molecular test
Diasorin received US FDA clearance and a CLIA waiver for a multiplex group A streptococcus assay on its Liaison Nes point-of-care PCR instrument. The Liaison Nes Group A Strep test is designed to...
Biogen buys RayThera to expand immunology small-molecule pipeline
Biogen agreed to acquire RayThera in a deal valued at up to $1 billion, adding a portfolio of early-stage immunology assets to the company’s pipeline. RayThera’s co-founders built a small-molecule...
Confo Therapeutics advances SSTR5 agonist CFTX-2034 for PBH
Confo Therapeutics presented preclinical characterization of CFTX-2034, a selective somatostatin receptor subtype 5 (SSTR5) agonist targeting life-threatening hypoglycemic episodes in...
Prime Medicine gets Medsafe clearance to begin Wilson’s trial
Prime Medicine obtained regulatory clearance from New Zealand’s Medsafe for its clinical trial application for PM-577a, a Prime Editor program targeting Wilson’s disease. The clearance advances...
Oxford Nanopore pushes rapid CNS tumor classification rollout in Norway
Oxford Nanopore expanded clinical adoption of rapid nanopore sequencing for CNS tumor classification through Norway’s MATRIX program and the country’s national precision diagnostics infrastructure...
F2G and Shionogi secure Phase III proof for oral antifungal olorofim
F2G and Shionogi released positive Phase III results for olorofim, an orally administered antifungal developed as a potential alternative to intravenous Ambisome for refractory aspergillosis. The...
Novo Nordisk invests in Czech and China footprint; Cellares raises Series D
Novo Nordisk is expanding manufacturing capacity through investments totaling about $380 million to grow its facility in Bohumil, Central Bohemia, in the Czech Republic. The update adds to...
AI + governance for regulatory filings: IDBS partners with Alchemi
IDBS and Alchemi partnered to accelerate AI-driven regulatory filings by connecting AI agents to IDBS Polar’s governed data foundation across the drug development lifecycle. The collaboration...
Pain pipeline consolidation at Eli Lilly via non-opioid MNK inhibition
Eli Lilly agreed to buy 4E Therapeutics, extending its focus on non-opioid pain medicines after prior acquisitions in the space, including the May 2025 purchase of SiteOne. The deal centers on...