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Latest Biotech News

Regulatory approvals - rare inflammatory disease drug

August 29, 2026

The FDA cleared Roivant’s brepocitinib, marketed as Lisraya, for adults with dermatomyositis—marking a major regulatory step for the company’s once-daily, oral inhibitor approach. The decision...

Oncology regulation and pipeline - ADC fast-track

August 29, 2026

The FDA granted fast track designation to CytomX Therapeutics’ varsetatug masetecan (Varseta-M; CX-2051), an EpCAM-directed masked antibody-drug conjugate for relapsed/refractory metastatic...

Biopharma funding and capital markets - Moderna raises for oncology

August 29, 2026

Moderna moved to bolster its oncology research footprint with a $2.6 billion fundraising round, an upsized offering designed to support continued drug development and pipeline expansion. The...

Biopharma funding - Gates Foundation invests in maternal health protein target discovery

August 29, 2026

The Gates Foundation committed up to $35 million to Profound Therapeutics to accelerate biomarker and drug target discovery for preeclampsia and eclampsia. The investment includes an initial $20...

Partnerships and licensing - DualityBio and Genentech in ADC pact

August 29, 2026

Genentech (Roche) and DualityBio entered a collaboration and license agreement centered on DualityBio’s DUPAC payload platform for next-generation antibody-drug conjugates. Genentech will fund the...

Molecular diagnostics reimbursement - MRD assay gains Medicare coverage

August 29, 2026

NeoGenomics won expanded Centers for Medicare and Medicaid Services MolDX coverage for its RaDar ST tumor-informed MRD assay, extending the test’s use into immunotherapy response monitoring for...

Biotech IP and legal - Parse and Scale/10x single-cell patents

August 29, 2026

A Delaware jury found that Parse Biosciences, a Qiagen subsidiary, willfully infringed three Scale Biosciences patents that were acquired by 10x Genomics in 2025, while also upholding the validity...

Corporate finance and restructuring - bankruptcy filing

August 29, 2026

BioXcel Therapeutics filed for Chapter 11 bankruptcy after concluding it could not secure sufficient funding to continue operations through the end of August. The company previously signaled...

Clinical immunotherapy - CAR T in rheumatoid arthritis remission signal

August 29, 2026

A first-in-human Phase 1 trial at Charité—Universitätsmedizin Berlin reported that CD19 CAR T-cell therapy pushed severe, treatment-refractory seropositive rheumatoid arthritis into remission in a...

FDA approvals – rare inflammatory disease

August 28, 2026

Roivant’s Priovant Therapeutics won U.S. FDA approval for Lisraya (brepocitinib), a once-daily oral pill targeting JAK1 and TYK2, for adults with dermatomyositis. The clearance marks the first...

Oncology – ADC development accelerates at FDA

August 28, 2026

CytomX Therapeutics received FDA fast track designation for varsetatug masetecan (Varseta-M; CX-2051), an EpCAM-directed masked antibody-drug conjugate, for relapsed/refractory metastatic...

Immuno-oncology – checkpoint blockade without key dendritic cells

August 28, 2026

Researchers at Hokkaido University and collaborators reported that immune checkpoint blockade can still trigger the first wave of tumor rejection even when cDC1 dendritic cells are absent. Their...

Oncology – functional genomics maps asciminib resistance

August 28, 2026

A genetic study mapped broad, convergent resistance mechanisms to asciminib in chronic myeloid leukemia (BCR::ABL1), identifying 279 resistance mutations. The work showed that escape can come from...

Platform and pipeline – RNA/DNA sequencing dispute in single-cell tech

August 28, 2026

A U.S. jury found that Parse Biosciences, a subsidiary of Qiagen, willfully infringed three patents tied to Scale Biosciences technology—acquired by 10x Genomics in 2025—while also upholding...

M&A and deals – Roche taps DualityBio for next-gen ADC payloads

August 28, 2026

Genentech inked a collaboration and license agreement with DualityBio centered on the DUPAC platform for next-generation ADCs aimed at topoisomerase-1 resistance. DualityBio is set to receive $45...

Biopharma financing – Moderna raises for cancer push

August 28, 2026

Moderna launched an upsized financing plan to support its oncology work, including cancer research investments alongside its broader mRNA platform strategy. The offering followed a separate series...

Regulatory and clinical – AstraZeneca/Amgen Tezspire nears new indication in EoE

August 28, 2026

AstraZeneca and Amgen said Tezspire (tezepelumab) cleared coprimary endpoints and all key secondary endpoints in a phase 3 trial for eosinophilic esophagitis (EoE). The Crossing study result...

Clinical development and trial execution – expanding Phase 1 WEE1 inhibitor program

August 28, 2026

Aprea Therapeutics is accelerating enrollment in its Phase 1 dose-escalation study of APR-1051, a WEE1 kinase inhibitor in DNA damage response, after early signs of clinical activity. The company...

Biotech startup and diagnostics – MRD test gains CMS coverage

August 28, 2026

NeoGenomics said its tumor-informed RaDar ST MRD assay received expanded coverage from CMS’ MolDX program to include immunotherapy response monitoring for late-stage solid tumors. The test uses...

Regulatory wins: rare disease approvals and updates

August 28, 2026

FDA cleared Priovant’s Lisraya (brepocitinib) for dermatomyositis, marking the first approval for a Roivant subsidiary drug licensed from Pfizer and expanding the company’s rare-inflammation...