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Regulatory: FDA panel endorses Moderna’s mRNA flu vaccine
FDA vaccine advisers endorsed Moderna’s seasonal mRNA influenza vaccine candidate, mRNA-1010, voting unanimously that benefits outweigh risks for both adults aged 50 to 64 and those 65 and older....
Antifungal pipeline: F2G and Shionogi clear Phase 3 path toward NDA resubmission
F2G and Shionogi released positive Phase 3 results for olorofim, an orally administered antifungal being developed with a potential regulatory rebound after a prior FDA complete response letter....
Antibiotic innovation: GSK-Spero’s oral Utebzi wins FDA approval for cUTI
GSK-Spero’s oral antibiotic Utebzi (tebipenem pivoxil hydrobromide) cleared the U.S. FDA approval hurdle for complicated urinary tract infections, including pyelonephritis. The decision comes four...
Rare neuro gene therapy: FDA reverses to let uniQure seek accelerated approval
The FDA reversed course again on uniQure’s Huntington’s disease gene therapy, AMT-130, clearing the company to file for U.S. approval under an accelerated pathway. UniQure said it will submit a...
CNS diagnostics: NCCN updates guidelines for CSF-based tumor profiling
NCCN updated its guidance to recommend cerebrospinal fluid (CSF)-based molecular tumor profiling for patients with high-grade glioma and glioblastoma when tissue biopsy is not feasible. The...
AI and regulation: IDBS and Alchemi connect agentic AI to governed submission data
IDBS and Alchemi announced a partnership designed to accelerate biopharma regulatory filings by linking AI agents to data governed in the IDBS Polar platform. The companies’ pitch targets a key...
Antibody discovery deal: Jazz adds AbCellera collaboration for next-gen T cell engagers
Jazz Pharmaceuticals entered a preclinical collaboration with AbCellera to discover and develop next-generation T-cell engaging multispecific antibodies for gastrointestinal cancers and other...
Diagnostics adoption: Oxford Nanopore expands rapid CNS tumor classification across Norway
Oxford Nanopore said the Norwegian Centre for Clinical Cancer Research (MATRIX) rolled out rapid nanopore-sequencing based CNS tumor classification across Norway’s public healthcare infrastructure...
Biotech funding: cAMPfield lands $180M Series A for oral IBD drug prifemilast
cAMPfield Therapeutics launched with an $180 million Series A to develop an oral inflammatory bowel disease therapy, prifemilast, aiming to compete in the long-term oral biologic substitute space....
FDA advisory committee clears Moderna’s mRNA-1010 flu vaccine for next step
A key FDA hurdle cleared Thursday as the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously that Moderna’s seasonal mRNA flu vaccine, mRNA-1010 (seeking brand...
UniQure gets FDA green light to pursue accelerated approval filing for Huntington’s therapy
The FDA reversed course on a closely watched Huntington’s disease gene therapy, clearing the path for uniQure (UniQure NV) to submit a U.S. marketing application. The decision supports an...
Biogen buys RayThera for up to $1B to expand immunology pipeline
Biogen agreed to acquire RayThera in a deal that could total as much as $1 billion, giving the neurology-focused company access to early-stage immunology assets. The portfolio centers on...
Oral antibiotics score FDA approvals after prior refusals: GSK-Spero’s Utebzi for cUTI
GSK and Spero Therapeutics won FDA approval for Utebzi (tebipenem pivoxil hydrobromide), an oral antibiotic for complicated urinary tract infections (cUTI), including pyelonephritis. The agency’s...
F2G and Shionogi advance oral olorofim for invasive aspergillosis with positive Phase 3 readout
F2G and Shionogi reported positive Phase 3 results for olorofim, an orally administered antifungal, setting up the next regulatory step after an earlier FDA complete response letter. The companies...
J-Pharma pushes LAT1 inhibitor nanvuranlat into global Phase 3 for biliary tract cancer
J-Pharma advanced nanvuranlat (JPH-203) into a global Phase 3 study after aligning with the U.S. FDA, initiating the Beacon-BTC trial in biliary tract cancer. The move marks a step forward for the...
Kardigan’s upsized $400M IPO feeds mid-stage cardiovascular drug pipeline
Kardigan Inc. priced an upsized $400 million biopharma IPO as it targets cardiovascular diseases through three mid-stage drug candidates. The company sold 25 million shares at $16 per share at the...
Oxford Nanopore brings rapid CNS tumor classification into Norway’s public precision diagnostics network
Oxford Nanopore Technologies said Norway’s MATRIX program has rolled out a rapid nanopore-sequencing approach for central nervous system (CNS) tumor classification across the country’s public...
FDA extends comment period on AI-powered real-time clinical trial pilot
The U.S. FDA extended the comment period on its AI-powered real-time clinical trial (RTCT) pilot program, pushing the deadline to June 29 in response to requests from sponsors and CROs for more...
cAMPfield launches with $180M Series A to pursue oral PDE4B-targeted IBD therapy
cAMPfield Therapeutics launched with a $180 million Series A round to develop prifemilast, an oral anti-inflammatory candidate for inflammatory bowel disease (IBD). The company is positioning...
FDA advisory board backs Moderna seasonal mRNA flu vaccine
A key FDA advisory panel moved Moderna’s seasonal mRNA influenza vaccine forward, voting unanimously that benefits outweigh risks for both adults ages 50–64 and those 65 and older. The Vaccines...