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GSK-Spero’s oral carbapenem Utebzi wins U.S. approval for complicated UTI
GSK-Spero’s oral antibiotic Utebzi (tebipenem pivoxil hydrobromide) cleared a U.S. FDA approval gate for complicated urinary tract infections (cUTI), including pyelonephritis. The agency approved...
UniQure gets FDA flexibility restored for Huntington’s gene therapy filing
The FDA reversed course again on uniQure’s Huntington’s disease gene therapy AMT-130, agreeing that a three-year analysis of early-stage data is acceptable to support an accelerated marketing...
F2G and Shionogi secure positive Phase 3 results for oral antifungal olorofim
F2G and Shionogi reported positive Phase 3 outcomes for olorofim, strengthening the companies’ case for an oral treatment option for invasive aspergillosis. The data showed noninferiority versus...
Biogen acquires RayThera for up to $1B to expand immunology pipeline
Biogen agreed to buy RayThera in a deal that could total up to $1 billion, securing an immunology-focused early pipeline with limited public disclosure from the target. The portfolio includes...
AI-driven regulatory filings move closer to scale with IDBS and Alchemi
IDBS partnered with Alchemi to accelerate AI-driven biopharma regulatory filings by connecting agentic workflows to Polar, IDBS’s governed data platform. The collaboration targets a long-running...
Norway rolls out Oxford Nanopore rapid nanopore sequencing for CNS tumor classification
Norway’s MATRIX program is integrating rapid nanopore-sequencing into the country’s national precision diagnostics infrastructure to speed CNS tumor classification. Oxford Nanopore said the...
Kardigan prices upsized $400M IPO to push three cardiovascular drugs toward Phase 3
Kardigan raised gross proceeds of about $400 million in an upsized IPO to fund three mid-stage cardiovascular programs with no available therapies. The company priced 25 million shares at $16 per...
Biotech regulatory framework for early-stage drug development is under scrutiny
A new Reagan-Udall Foundation for the FDA report lays out a set of recommendations to preserve U.S. leadership in early-stage drug development as China expands its pipeline capabilities. The...
U.S. FDA extends comment period for AI-powered real-time clinical trials pilot
The FDA extended the public comment period for its AI-powered real-time clinical trial (RTCT) pilot, giving sponsors and CROs more time to respond to proposed approaches for using AI in endpoint...
FDA regulatory turnaround for Huntington’s gene therapy
UniQure won a key FDA reversal that clears the path to file for accelerated approval of its Huntington’s disease gene therapy, AMT-130. The company said the agency agreed that a three-year...
Advisory committee endorses Moderna’s mRNA seasonal flu vaccine
FDA vaccine advisers voted unanimously that the benefits of Moderna’s mRNA-1010 seasonal flu vaccine outweigh the risks for both adults ages 50 to 64 and those 65 and older. The Vaccines and...
Big Pharma steps into immunology with Biogen’s RayThera buyout
Biogen agreed to acquire RayThera in a deal that could be worth up to $1 billion, gaining a portfolio of early-stage immunology candidates led by programs near the clinic. Details remain limited,...
Phase 3 pathway clears for F2G’s first novel antifungal in decades
F2G and Shionogi released positive Phase 3 results for orally administered olorofim, moving the program back toward regulatory resubmission after an earlier FDA complete response letter rebuff....
Merger-of-evidence approach: IDBS and Alchemi automate regulated filing drafting
IDBS and Alchemi announced a partnership designed to speed up regulated biopharma submissions by connecting AI agents to data governed inside the IDBS Polar platform. The focus is on regulatory...
New oral antibiotic gets FDA nod after a long CRL gap
GSK-Spero’s oral antibiotic tebipenem pivoxil hydrobromide, branded Utebzi, received U.S. FDA approval for complicated urinary tract infections (cUTI), including pyelonephritis. The approval came...
IPO window stays open as Kardigan upsizes to $400M for cardiology pipeline
Kardigan priced an upsized initial public offering to raise $400 million gross to fund three mid-stage cardiovascular drug candidates targeting root causes of heart disease. The company priced 25...
China sets new clinical commercialization framework for advanced therapeutics
China issued Order 818 governing the administration of clinical research and clinical translation and application of biomedical new technologies, establishing a pathway intended to accelerate...
AI-enabled real-time clinical trial pilot: FDA extends comment deadline
The FDA extended the comment period for its AI-powered real-time clinical trial (RTCT) pilot assessment, moving the deadline to June 29. The agency said the extension responded to requests from...
US investment scrutiny for China biotech enters Treasury discussions
Treasury Department officials are weighing potential restrictions on U.S. investments in China’s biotech sector, according to multiple sources familiar with internal discussions. The consideration...
FDA regulatory flexibility for gene therapy filings
The FDA has reversed course on UniQure’s Huntington’s disease gene therapy, clearing the company to pursue an accelerated approval filing for AMT-130. UniQure said the agency accepted that a...