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Latest Biotech News

Big pharma ophthalmology M&A

May 08, 2026

Bayer struck a deal to expand its ophthalmology pipeline by acquiring Perfuse Therapeutics for up to $2.45 billion. The purchase gives Bayer full rights to PER-001, a small-molecule endothelin...

FDA reconsideration for cell therapy

May 08, 2026

Pierre Fabre and Atara Biotherapeutics won a significant pivot from the U.S. FDA on Ebvallo (tabelecleucel) after the agency’s earlier surprise rejection. The FDA agreed to reconsider approval...

Digital pathology consolidation

May 08, 2026

Roche agreed to acquire PathAI in a deal potentially worth up to $1.05 billion, aiming to accelerate the rollout of AI-powered diagnostic tools within Roche Diagnostics. The acquisition includes a...

Precision oncology startup funding

May 08, 2026

Imagenomix, an NYU Langone spinout developing AI-driven cancer diagnostics from standard histopathology images, raised $3.2 million in seed funding. The company said it uses AI to detect genetic...

Biotech IPO market: autoimmunity

May 08, 2026

Odyssey Therapeutics priced and launched its initial public offering, raising $279 million at $18 per share, plus an additional $25 million from a concurrent private stock sale at the same price....

Obesity drug competition intensifies on next-gen formulations

May 08, 2026

A University of Virginia study reported mechanistic data in mice suggesting next-generation oral small-molecule GLP-1 receptor agonists suppress hedonic eating through reward circuits deeper in...

Multiplexed MRD diagnostics: commercial momentum

May 08, 2026

BillionToOne reported a surge in Q1 2026 revenue driven by increased prenatal and oncology-related clinical testing. The company posted $108.4 million in Q1 revenue, up 84% year over year, with...

Cell therapy manufacturing automation

May 08, 2026

Cellular Origins expanded its collaboration with Immatics to use Cellular Origins’ automated mobile robotic platform, Constellation, in parts of Immatics’ cell therapy manufacturing workflows. The...

Regulatory science: cell therapy resubmission dynamics

May 08, 2026

Atara and Pierre Fabre’s Ebvallo resubmission plan follows the FDA’s decision to reconsider the regulatory evidence strategy after a second discussion with agency officials. The companies said the...

Biopharma AI diagnostics investment

May 08, 2026

Roche’s PathAI acquisition follows a broader wave of investment in AI-enabled diagnostics, as the pharma giant seeks to scale digital pathology tools for precision oncology. PathAI’s platform...

Cell therapy approval path resets for Ebvallo

May 08, 2026

The FDA has agreed to reconsider approval for Atara Biotherapeutics and Pierre Fabre Pharmaceuticals’ allogeneic T-cell therapy Ebvallo (tabelecleucel) after a surprise January rejection. The...

Big Pharma M&A: Angelini buys Catalyst to expand rare neuro portfolio in the U.S.

May 08, 2026

Angelini Pharma agreed to acquire Catalyst Pharmaceuticals for about $4.1 billion in cash, adding three FDA-approved rare disease medicines to its portfolio and creating a direct entry into the...

Digital pathology consolidation: Roche to buy PathAI

May 08, 2026

Roche agreed to acquire PathAI for up to $1.05 billion to expand its digital pathology capabilities and bolster biopharma services. Under the terms, Roche will pay $750 million upfront and up to...

FDA reconsideration of T-cell therapy in EBV+ PTLD boosts Atara’s odds

May 08, 2026

The FDA’s updated stance on Ebvallo centers on using the existing single-arm Allele trial with an appropriate historical control rather than demanding a new randomized study. The companies said...

Immuno-oncology pipeline stumbles: Entrada and Engene face sharp reversals on early bladder/DMD oncology data

May 08, 2026

Entrada’s shares plunged after initial dystrophin readouts for ENTR-601-44 in Duchenne muscular dystrophy came in below what investors expected. The trial met safety and tolerability, and...

Next-gen obesity: Eli Lilly’s tirzepatide climbs and Novo’s Wegovy pill momentum continues

May 08, 2026

Eli Lilly’s Mounjaro moved past Merck’s Keytruda for the first time, driven by accelerating tirzepatide sales that also benefited from strong contributions within combination demand. The...

Precision diagnostics: BillionToOne expands Unity portfolio with Unity Confirm expectations

May 08, 2026

BillionToOne told investors it expects Unity Confirm to drive further gains in its prenatal testing franchise. The company said the circulating fetal cell-based confirmatory assay is designed to...

Biotech IPO window reopens: Odyssey raises $279M in second attempt

May 08, 2026

Odyssey Therapeutics priced an initial public offering that raised $279 million after a more than year-long process, marking the second attempt to access public markets. The autoimmune disease...

Industrial genetics tooling: DNAstack and PhenoTips integrate clinical genetics workflows

May 08, 2026

DNAstack and PhenoTips announced they have integrated their informatics platforms to enable an end-to-end clinical genetics workflow that combines structured phenotype capture with genomic...

CDMO scale-up: Lonza targets ADC manufacturing with new site and hiring plans

May 08, 2026

Lonza said it aims to expand its antibody-drug conjugate manufacturing footprint with a new manufacturing site coming online next year and plans to increase headcount. The company framed the move...