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Latest Biotech News

FDA approvals and label expansions

May 02, 2026

The U.S. Food and Drug Administration approved Arvinas and Pfizer’s Veppanu (vepdegestrant) for metastatic ER-positive, HER2-negative breast cancer with ESR1 mutations that progressed after at...

Longer-term clinical evidence for targeted oncology

May 02, 2026

Rigel Pharmaceuticals published final Phase 1/2 ARROW study data for its once-daily oral RET inhibitor pralsetinib (GAVRETO) in RET fusion-positive metastatic non-small cell lung cancer. The...

FDA/regulatory leadership churn at CBER

May 02, 2026

Vinay Prasad stepped aside as director of the FDA’s Center for Biologics Evaluation and Research (CBER), with Katherine Szarama, Ph.D., taking over as acting director while regulators search for a...

Disputed oncology approval narrative and agency pushback

May 02, 2026

A new report on RP1, an oncolytic immunotherapy from Replimune Group, details why the FDA twice declined to approve the melanoma drug despite breakthrough therapy designation and early trial...

Biotech fundraising via IPO and venture rounds

May 02, 2026

Seaport Therapeutics and Hemab Therapeutics continued the IPO resurgence with upsized offerings. Seaport joined Nasdaq on May 1 with gross proceeds of $254.9 million, while Hemab priced a $301.5...

Regulatory and evidence expectations in epigenetics diagnostics acquisition

May 02, 2026

Infinite Epigenetics agreed to acquire Tally Health, a move aimed at building a diagnostics-to-intervention platform spanning epigenetic testing, adult DNA methylation datasets, and personalized...

Company leadership and C-suite moves

May 02, 2026

Guardant Health disclosed that Craig Eagle, the company’s chief medical officer, will resign effective May 8. Eagle previously held oncology medical affairs roles at Genentech (Roche) and...

New study: immune-cell biology to reverse T-cell exhaustion

May 02, 2026

Researchers at UC San Diego reported in a Cell paper that restoring protein recycling can reverse aspects of T-cell exhaustion in mice. The study, led by work from the lab of Ananda Goldrath,...

Platform innovation: digital manufacturing for biopharma

May 02, 2026

Cytiva and Rockwell Automation launched Figurate SCADA, aimed at reducing digital bottlenecks across biopharmaceutical manufacturing. The system is positioned as open-architecture supervisory...

New therapy development platform: cancer detection with nanoparticle approach

May 02, 2026

Oregon Health & Science University (OHSU) researchers developed a nanoparticle-based approach designed to improve early detection of pancreatic cancer. The article highlights the clinical problem...

FDA approval: Arvinas’ Veppanu expands precision oncology option

May 02, 2026

The FDA approved Arvinas and Pfizer’s Veppanu (formerly vepdegestrant), a proteolysis-targeting chimera (PROTAC), for a biomarker-defined subgroup of adults with metastatic estrogen...

Melanoma oncolytic immunotherapy: FDA rejects RP1 for the second time

May 02, 2026

FDA has twice declined to approve Replimune Group’s oncolytic immunotherapy RP1, despite the program receiving breakthrough therapy designation and fast-track attention after early trial results....

Oncology trial readout: Rigel’s pralsetinib ARROW data extends durable RET+ NSCLC responses

May 02, 2026

Rigel Pharmaceuticals published final long-term results from the Phase 1/2 ARROW study of pralsetinib (Gavreto) in RET fusion-positive metastatic NSCLC in the Journal of Clinical Oncology. The...

Immuno-oncology biology: activated T cells deliver EV DNA that boosts antigen presentation

May 02, 2026

Weill Cornell Medicine researchers reported in Cancer Cell that activated T cells secrete extracellular vesicles carrying DNA, which can enter tumor and immune cells to enhance antigen processing...

Regulatory and agency leadership: FDA’s CBER transitions to acting director Szarama

May 02, 2026

Vinay Prasad stepped aside as FDA’s Center for Biologics Evaluation and Research (CBER director), and Katherine Szarama will lead as acting director while the agency continues searching for a...

Clinical pipeline failure: Krazati confirmatory colorectal trial misses, risking approval status

May 02, 2026

Bristol Myers Squibb’s Krazati failed its confirmatory trial in second-line colorectal cancer, raising uncertainty about the therapy’s regulatory status. The company confirmed the failure to...

Biopharma funding and IPO execution: Hemab and Seaport continue IPO surge

May 02, 2026

Two biotechs—Seaport Therapeutics and Hemab Therapeutics—priced IPOs in the latest wave of enlarged debuts, adding to a 2026 IPO resurgence. Seaport’s offering raised $254.9 million gross proceeds...

Bioprocessing infrastructure: Cytiva and Rockwell unveil interoperable biopharma SCADA

May 02, 2026

Cytiva and Rockwell Automation launched Figurate SCADA, a supervisory control and data acquisition system aimed at reducing digital bottlenecks in biopharmaceutical manufacturing. The product is...

Biotech finance: more money raised across early 2026, with key IPO and venture activity

May 02, 2026

Biopharma capital markets coverage highlighted continued liquidity across public and private financings through early 2026. The data set of “money raised by biopharma” tracking public, private,...

Dealmaking and corporate moves: Infinite Epigenetics acquires Tally Health

May 02, 2026

Infinite Epigenetics announced its acquisition of Tally Health, expanding its capabilities across epigenetic diagnostics, adult DNA methylation datasets, and personalized intervention offerings....