Latest Biotech News

The EMA’s CHMP backed two orphan drugs while rejecting a previously FDA-approved treatment pathway related to Niemann-Pick disease type C, according to regulator updates compiled in BioCentury’s...

Sanofi said it will not seek approval of amlitelimab in atopic dermatitis, calling the OX40-ligand monoclonal antibody unlikely to provide a meaningful improvement over current standards of care...

A new analysis of patients treated with Kite’s CAR-T therapy Yescarta has identified genetic signals associated with toxicity risk and points to a mechanism that could inform safer CAR-T designs....

Scribe Therapeutics raised new capital in a CRISPR-focused IPO priced at $15 per share, extending what industry watchers describe as a strong run of biotech public debuts. The offering included...

An FDA advisory panel narrowly supported allowing compounding pharmacies to manufacture the peptide epitalon, while recommending against compounding emideltide. The votes followed the panel’s...

Amgen shared a fresh analysis with the FDA supporting continued marketing of Tavneos, the company’s therapy for a rare disease that has become the center of an FDA dispute. The submission, filed...

Codexis priced a public offering of about 16.7 million shares at $1.50 each, targeting net proceeds of about $23.1 million to fund working capital and general corporate purposes, including...

Royalty Pharma agreed to pay Neurimmune $125 million upfront for a royalty interest in cliramitug, a TTR-fibril-depleting antibody designed to clear amyloid deposits in transthyretin amyloidosis...

Pythia Biosciences and Lexogen expanded their collaboration by integrating Lexogen’s single-cell and bulk RNA-seq services into Pythia’s Pythia Data Universe platform. The companies said the...

Transcripta Bio raised $24 million since its Series A to fund IND-enabling studies and advance multiple neuro-focused programs. The company plans to use proceeds for clinical preparation in autism...

A retraction-and-ethics spotlight on an unapproved, brain-directed CRISPR/based-editor case in China has reignited questions about medical oversight for experimental gene editing in human...

An FDA advisory panel recommended broader use of some compounded peptides while narrowly stopping others, moving the policy conversation closer to the U.S. government’s push for greater access to...

The EMA’s Committee for Medicinal Products for Human Use (CHMP) delivered two orphan-drug decisions—backing Minoryx’s ALD therapy while issuing a negative stance on a separate Niemann-Pick disease...

A new analysis of patients treated with Kite Pharma’s CAR-T therapy Yescarta (axi-cel) has identified genetic signatures linked to toxicity risk, pointing to potential biomarkers and engineering...

Sanofi has scrapped plans to seek approval of amlitelimab in atopic dermatitis, concluding the OX40-ligand monoclonal antibody would not represent a meaningful improvement over the standard of...

Scribe Therapeutics priced an upsized IPO at the top of its range, raising about $129 million gross as it begins trading on Nasdaq under ticker SCTX. The company sold 8.6 million shares at $15...

Sprint Bioscience signed an agreement to use Eli Lilly’s AI-based drug discovery platform Tunelab to support research across its portfolio. The deal reflects continued uptake of large-company AI...

A cohort-matched analysis reports that GLP-1 receptor agonist therapy is associated with lower long-term mortality and adverse limb outcomes in patients with peripheral artery disease (PAD) and...

Royalty Pharma struck a deal with Neurimmune for a royalty interest tied to cliramitug, a TTR-fibril-depleting antibody in Phase III for transthyretin amyloidosis with cardiomyopathy (ATTR-CM)....

Roche received FDA clearance for a molecular vaginitis test targeting bacterial vaginosis and Candida vaginitis from clinician-collected or self-collected vaginal swabs. The assay clearance...