Latest Biotech News

A new indication-by-indication analysis is reshaping how the gene therapy field thinks about recombinant AAV (rAAV) manufacturing costs and capacity. The study assesses six leading targets—RPE65...

Amgen escalated its effort to settle an FDA dispute over Tavneos by submitting an independent reevaluation analysis supporting continued market access for the drug. The company said the new...

An FDA advisory panel recommended that compounding pharmacies be allowed to manufacture epitalon while narrowly voting against allowing pharmacies to make emideltide. The votes followed a previous...

Researchers identified genetic red flags tied to toxicity risk in Yescarta (axi-cel) recipients, using patient data from Kite’s Zuma-1 and Zuma-7 clinical trials. The analysis, published in...

A new preclinical study reported that GHP-88310, an oral antiviral polymerase inhibitor, blocks measles-like virus transmission in a ferret model. Published in Nature Microbiology, the work showed...

Kobe University reported preclinical evidence for mass-produced, off-the-shelf induced pluripotent stem cell (iPSC)-derived allogeneic gamma delta T cells against colorectal cancer. In a study in...

Researchers advanced liquid biopsy profiling concepts aimed at capturing antitumor immune responses without repeated tissue sampling. The report focuses on the limitations of tumor biopsy as the...

Oncologists warned that shortages of key generic chemotherapy drugs are forcing substitution and workarounds that could undermine treatment for some curable cancers. The report highlights...

A genome-wide host-directed screening strategy identified both potential antiviral drug candidates and cellular signaling routes hijacked by SARS-CoV-2. The study, published in npj Viruses, used...

Candid Health raised $120 million for an AI platform aimed at revenue cycle management (RCM), signaling continued investor appetite for automation in healthcare operations. The Series D round was...

Scribe Therapeutics opened trading after pricing an upsized IPO, signaling fresh investor appetite for CRISPR-based pipeline bets. The company priced 8.6 million shares at $15 each for about $129...

Codexis priced a public offering to bolster working capital and advance manufacturing and enzyme innovation for therapeutics. The company announced the sale of about 16.7 million shares at $1.50...

A new analysis of Kite’s Yescarta (axi-cel) trial data linked patient genetics to toxicity risk in CAR-T therapy. Researchers reporting in Science Immunology found that mutations in STXBP2...

An FDA advisory panel narrowly recommended allowing compounding pharmacies to manufacture the peptide epitalon while voting against manufacturing emideltide. The panel’s decisions follow a similar...

EMA’s CHMP backed two orphan drug therapies and rejected a separate option tied to an FDA-approved NPC treatment. In the BIOCentury regulation coverage, Minoryx’s cALD therapy received backing...

Sanofi scrapped plans to seek approval of amlitelimab in atopic dermatitis, saying the OX40-ligand antibody would not deliver meaningful improvement over standard care. The decision marks an...

Zevra Therapeutics said it will pursue a re-examination after CHMP adopted a negative opinion on arimoclomol for Niemann-Pick disease type C. The company’s submission for a marketing authorization...

Georgia State University researchers reported that the oral polymerase inhibitor candidate GHP-88310 blocked both airborne and contact-mediated transmission in a ferret measles-like model. The...

University of Chicago-led researchers reported a preclinical strategy using engineered gut bacteria to reshape pancreatic cancer’s immune microenvironment. The Science Advances study describes...

Kobe University researchers reported preclinical efficacy for mass-produced, allogeneic iPSC-derived gamma delta T cells against colorectal cancer. Writing in Stem Cell Reports, the team described...