Get the Daily Brief
Latest Biotech News
FDA greenlights new oncology medicine in cholangiocarcinoma
The FDA approved lirafugratinib (Lyrfigtu) for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or other rearrangements. The...
ADARx’s IPO brings RNAi biotech to public markets with AbbVie support
ADARx Pharmaceuticals priced an upsized initial public offering on Nasdaq, raising $446.3 million at $17 per share and adding an AbbVie investment alongside the launch. The IPO marks a key...
Merck expands Welireg use with new kidney-cancer combination
Merck received FDA approval to expand Welireg (belzutifan) into a broader set of kidney cancer patients when used in combination with Eisai’s Lenvima (lenvatinib). The new label applies to...
Novo and Nanexa ink long-acting drug delivery deal worth up to $1.3B
Novo Nordisk agreed to a licensing arrangement with Nanexa for a long-acting injectable drug-delivery technology, with deal value reported at up to €1.165 billion (about $1.325 billion). The...
Lilly pays up to $3.35B to access InnoCare discovery platform
Eli Lilly signed a discovery-stage collaboration with Beijing-based InnoCare Pharma, reported as worth up to $3.35 billion, to identify and advance compounds across as many as five undisclosed...
Oncolytic virotherapy gains spotlight with engineered vaccinia candidate
An engineered oncolytic vaccinia virus, GC001, showed potent tumor-killing activity alongside a built-in gene-silencing payload in preclinical and translational reporting. The study was published...
CAR-T expands deeper into autoimmune and solid-tumor territory
A comprehensive review in Clinical Cancer Bulletin maps how CAR-T therapy is pushing beyond blood cancers and into solid tumors and autoimmune diseases. The paper summarizes regulatory progress...
Global anticancer testing: FDA advisory panel backs Galleri with concerns over follow-up use
An FDA advisory panel backed Grail’s Galleri multicancer blood test, voting that probable benefits outweigh risks in a 7–2 decision, with one member abstaining. The debate centered on false...
Regulatory pathway question: when one pivotal trial can be enough
Industry groups and pharmaceutical companies are pushing the FDA to provide clearer guidance on when sponsors can rely on one pivotal trial plus confirmatory evidence for approval decisions. The...
LPS safety review supports controlled human inflammation research
A massive review from Purdue University concludes that deliberate administration of lipopolysaccharide (LPS)—a purified bacterial endotoxin—into healthy volunteers is, by and large, remarkably...
FDA approvals – oncology
The FDA has approved lirafugratinib (Lyrfigtu) for adults with previously treated unresectable, locally advanced, or metastatic cholangiocarcinoma harboring FGFR2 fusions or other rearrangements....
IPO and market access – RNA therapeutics
ADARx Pharmaceuticals priced an upsized $446.3 million IPO as it enters Nasdaq trading under ADRX, adding momentum to the RNA therapeutics fundraising cycle. The company sold 26.25 million shares...
M&A and litigation – Nektar vs Eli Lilly
A U.S. jury awarded Nektar Therapeutics $90 million in damages over a fractured licensing dispute involving Eli Lilly and rezpeg, according to the latest legal readout. The jury found Lilly...
Partnerships – cardiometabolic drug delivery
Novo Nordisk agreed a deal worth up to €1.165 billion (US$1.325 billion) for a global exclusive license to Nanexa’s drug delivery technology, targeting longer-acting peptide formulations for its...
Clinical pipeline – Alzheimer’s psychosis setback and Phase 3 path
Acadia Pharmaceuticals reported that its Phase 2 Alzheimer’s disease psychosis study with remlifanserin missed the primary endpoint, but the company said the signal supports moving into Phase 3...
Platform and drug discovery – computational biology and translation
A new approach to suppressing disease-associated RNA activity is gaining momentum in drug discovery as researchers reported advances in predicting and engineering challenging targets. Among the...
Cell therapy – durable autoimmune benefit in CAR-T
Kyverna Therapeutics said it has produced one-year data supporting an FDA submission path for its rare autoimmune CAR-T program. The company highlighted positive long-term findings in patients...
Diagnostics and early detection – multicancer screening policy risk
FDA advisers backed Grail’s Galleri multicancer blood test, voting that probable benefits outweigh risks, while still expressing concerns about effectiveness and the consequences of false...
Research and translational oncology – tumor microenvironment and metastasis biology
Researchers built a database aimed at capturing hidden RNA editing events in cancer’s circulating microRNAs and related “tiny messengers.” The work centers on extracellular vesicles, which can...
Manufacturing and CDMO capacity – EMA GMP certification in biologics
Altruist Biologics’ Suzhou manufacturing site received EMA GMP certification with zero critical findings, the company said. The certification supports an EU marketing authorization application for...