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Latest Biotech News

Crescent Biopharma inks Kelun ADC pact and raises $185M — combo strategy

December 05, 2025

Crescent Biopharma struck a two‑way alliance with Kelun‑Biotech to access an antibody‑drug conjugate the company plans to test with its PD‑1xVEGF bispecific, and concurrently closed a $185 million...

Manufacturing and assay capacity expands — Avance opens potency center; BioNexus funds build

December 05, 2025

Avance Biosciences opened a Potency and Cell‑Based Assay Center of Excellence in Houston to centralize GMP‑compliant potency assay development and testing for biologics, RNA therapeutics, vaccines...

Capricor's Duchenne win... FDA standoff shifts to resubmission

December 05, 2025

Capricor announced positive topline results from the pivotal Phase 3 HOPE-3 trial of deramiocel, showing statistically significant improvements in both upper-limb performance and a key cardiac...

12 former FDA chiefs strike back: vaccine-rule overhaul under fire

December 05, 2025

A coalition of nearly all living past FDA commissioners published a sharp rebuke in the New England Journal of Medicine opposing plans by the FDA's biologics and vaccines chief to toughen vaccine...

Pharvaris' oral HAE pill clears Phase 3 — filing on deck

December 05, 2025

Pharvaris reported that deucrictibant met primary and secondary endpoints in a pivotal Phase 3 study as an on‑demand treatment for hereditary angioedema (HAE). The company said symptom relief...

Pfizer‑backed Triana nets $120M — molecular glue moves to clinic

December 05, 2025

Triana Biomedicines closed a $120 million Series B round led by Pfizer Ventures and other investors to advance its molecular glue degrader pipeline toward clinical proof‑of‑concept. The financing...

AI drug design... Terray hits BMS milestone; Baker lab opens RFdiffusion3

December 05, 2025

Terray Therapeutics announced a discovery milestone under its multi‑target collaboration with Bristol Myers Squibb, citing its EMMI platform and tArray hardware to find small molecules against a...

Journal retracts Monsanto‑backed glyphosate safety paper — legal storm follows

December 05, 2025

Regulatory Toxicology and Pharmacology retracted a highly cited paper that had concluded glyphosate posed no cancer risk, citing reliance on unpublished Monsanto studies, possible ghostwriting,...

UniQure told more work needed on Huntington gene therapy — stock slides

December 05, 2025

UniQure reiterated that FDA staff conveyed negative feedback on its AMT‑130 Huntington’s disease dossier, indicating current data likely fall short for approval. The company said it received final...

CARB‑X doubles down on rapid diagnostics — pediatric and STI prizes awarded

December 05, 2025

CARB‑X awarded funding to accelerate two point‑of‑care diagnostic efforts: ProtonDx received $1 million to evaluate a blood‑based host RNA assay for pediatric lower respiratory infections using...

NeuMap atlas charts neutrophil diversity — Nature maps 1M+ cells

December 05, 2025

An international consortium led by CNIC, Universidad Carlos III de Madrid, Yale and Westlake University published NeuMap in Nature, the first comprehensive single‑cell transcriptional atlas of...

Illumina pivots: BioInsight to sell data packages and AI‑ready genomic sets

December 05, 2025

Illumina launched BioInsight, a business unit offering to run and retain ownership of large, costly sequencing projects for pharma customers and to develop packaged datasets and analytic tools....

Former FDA commissioners sound alarm: Prasad's vaccine plan 'endangers public health'

December 04, 2025

Twelve former FDA commissioners publicly criticized CBER Director Vinay Prasad's plan to tighten vaccine update requirements in a New England Journal of Medicine piece, arguing the proposal risks...

ACIP in disarray — Vote on newborn hepatitis B shot postponed

December 04, 2025

The CDC's Advisory Committee on Immunization Practices (ACIP) postponed a planned vote on changing the universal birth dose recommendation for hepatitis B after deliberations devolved into...

Capricor's cell therapy clears Phase 3 — Shares skyrocket

December 04, 2025

Capricor Therapeutics announced positive topline results from its pivotal Phase 3 HOPE‑3 trial of deramiocel in Duchenne muscular dystrophy (DMD), meeting the primary functional endpoint and a key...

Pharvaris pill wins Phase 3 — Rapid relief for hereditary angioedema

December 04, 2025

Pharvaris reported Phase 3 results showing its oral bradykinin B2 receptor antagonist deucrictibant met primary and secondary endpoints as an on‑demand treatment for hereditary angioedema (HAE)...

UniQure's AMT‑130 path muddied — shares slide after FDA rebuff

December 04, 2025

UniQure said it received formal FDA meeting minutes indicating agency staff view its current dataset for AMT‑130, a Huntington’s gene‑silencing therapy, as likely insufficient for approval. The...

Regeneron-Tessera pact: $150m to write genes for AATD

December 04, 2025

Regeneron agreed to a strategic collaboration with Tessera Therapeutics, investing $150 million to develop TSRA‑196, a gene‑writing program targeting alpha‑1 antitrypsin deficiency (AATD). Tessera...

Triana nets $120m — molecular glue degrader heads to clinic

December 04, 2025

Triana Biomedicines closed a $120 million Series B financing led by Pfizer Ventures and other investors to advance its molecular glue degrader pipeline into clinical development. The...

SciNeuro raises $53m — to revive a former GSK neuro compound

December 04, 2025

SciNeuro Pharmaceuticals secured $53 million in venture funding led by ARCH and Lilly Asia to advance an asset originally from GSK into clinical studies for diabetic ocular complications and...