Latest Biotech News

The FDA launched an “Expedited Investigational New Drug (IND) Pilot” under Operation Trialblazer, aiming to shorten the timeline for first-in-human studies in the U.S. rather than starting trials...

The FDA said it will increase resources for foreign bioresearch monitoring (BIMO) inspections and update risk-based criteria for selecting overseas clinical trial sites for audits. Acting Director...

Dualitas Therapeutics secured its first major partner in Roche Holding AG to use the Dualscreen bispecific discovery engine, with the collaboration valued at up to $1 billion. Dualitas will screen...

Novo Nordisk agreed to an up to $1.4 billion multitarget partnership with Orbis Medicines, deepening its push toward oral biologics using synthetic macrocycles. Orbis’ macrocycle platform...

Novartis exercised an option to acquire global rights to Sironax’ brain delivery platform, paying $125 million at closing. The technology is intended to help deliver a range of therapeutic...

Cellares and GenomeFrontier Therapeutics entered a partnership to evaluate automated manufacturing for GenomeFrontier’s virus-free GF-CART01 using Cellares’ Cell Shuttle platform. The...

Mithrl raised a $20 million Series A led by Obvious Ventures to expand deployment of its “biomedical world model” across biopharma R&D workflows. The company said its platform aims to move teams...

Researchers published a new genome engineering method called “prime assembly” in Nature that enables targeted integration of long DNA fragments into precise genomic locations. The approach uses...

North Immunology is going public through a reverse merger with Aethlon Medical, raising $180 million as it advances a long-acting immunology and inflammation program for atopic dermatitis. The...

Roche moved to broaden access for its T cell engager Lunsumio after clearing a Phase 3 confirmatory study in a slow-growing lymphoma subtype. The result is set to support full approval and an...

The FDA outlined two complementary moves aimed at reshaping how studies start and how foreign trial data are scrutinized. First, the agency launched an Expedited Investigational New Drug (IND)...

The FDA approved taletrectinib for patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer, marking a new targeted option in a genomically defined subgroup. By...

Novo Nordisk is funding an oral biologics push with a large alliance to Orbis Medicines targeting cardiometabolic diseases. Under the agreement, Novo can pay up to $1.4 billion in upfront and...

Mithrl raised $20 million in Series A funding led by Obvious Ventures to expand deployment of its biomedical world-model platform for accelerating discovery through IND. The company said Mithrl-1...

North Immunology is joining the reverse-merger pipeline, aiming to bring an atopic dermatitis antibody to clinical development while raising capital through a public listing structure. The company...

Sartorius and NIBRT announced a partnership to establish a training center in Dublin focused on intensified and fully continuous bioprocessing. Starting in Q4 2026, the Process Intensification...

Novartis moved to strengthen its neuroscience pipeline by paying Sironax $125 million for a blood-brain barrier crossing platform. The acquisition is designed to improve delivery of large...

Cellares and GenomeFrontier Therapeutics entered a manufacturing collaboration to evaluate automated processing for GF-CART01 on Cellares’ Cell Shuttle platform. The partnership aims to translate...

Cornell University researchers reported preclinical evidence for GL-4512, an LILRB4 (ILT3) modulator designed to relieve myeloid-driven immune suppression in cancer models. LILRB4 is described as...

The FDA approved taletrectinib for patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer, creating a new targeted option for a defined genomic subset. The approval...