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Oncology trial readout: Rigel’s pralsetinib ARROW data extends durable RET+ NSCLC responses
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
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
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
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
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
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
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
Infinite Epigenetics announced its acquisition of Tally Health, expanding its capabilities across epigenetic diagnostics, adult DNA methylation datasets, and personalized intervention offerings....
Regulatory approvals – PROTAC breast cancer launch
The FDA has approved Arvinas’ Veppanu (vepdegestrant) for adults with metastatic estrogen receptor–positive, HER2-negative breast cancer with ESR1 mutations whose disease has progressed after at...
FDA oncology decision – advisory panel rejects ctDNA-driven switching
An FDA oncology advisory committee voted 6–3 that evidence does not support switching patients to AstraZeneca’s camizestrant based on ESR1 mutations detected in circulating tumor DNA. The panel’s...
FDA label expansion – Alzheimer’s agitation treatment
The FDA approved Axsome Therapeutics’ Auvelity (AXS-05) for Alzheimer’s disease agitation, expanding the indication for a drug that already has a history in major depressive disorder. The label...
Clinical failure – confirmatory trial risks accelerated approval
Bristol Myers Squibb’s Krazati failed its confirmatory trial in second-line colorectal cancer, according to the company’s spokesperson. The result puts the drug’s accelerated approval status in...
Preclinical immuno-oncology – T-cell exhaustion reversed via proteostasis
Researchers at UC San Diego reported in a new Cell study that reversing T-cell exhaustion in mice may hinge on restoring impaired cellular protein recycling. The work identifies proteostasis...
Biotech financing and IPOs – IPO resurgence continues
Three biotechs advanced Wall Street momentum with large, upsized IPOs as equity appetite for early commercial potential persists. Seaport Therapeutics raised $254.9 million gross on a Nasdaq debut...
Biotech market structure and policy – PBM transparency reform spotlight
A policy panel discussion highlighted how U.S. PBM reform rules are forcing operational change through mandatory rebate pass-through and transparency requirements. Brendan Buck of the...
Gene therapy regulatory pathway – Huntington’s gene therapy steps toward UK submission
UniQure said it will seek UK approval for its Huntington’s gene therapy AMT-130, submitting a marketing application later this year following a positive meeting with UK regulators. The update...
Company leadership – FDA CBER acting director named amid search
The FDA named Katherine Szarama as acting director of the Center for Biologics Evaluation and Research (CBER) as the search for a permanent leader continues. Szarama will replace Vinay Prasad, who...
Gene editing tools – DNA-guided CRISPR Cas12a enables RNA targeting
Researchers reported a DNA-guided CRISPR–Cas12a system that enables programmable RNA recognition and cleavage, expanding Cas12a beyond RNA-guided operation. The approach, described in a DNA-guided...
First FDA approval of a PROTAC in breast cancer
The FDA approved Arvinas and Pfizer’s Veppanu (formerly vepdegestrant) for a defined subgroup of adults with metastatic estrogen receptor–positive, HER2-negative breast cancer that progressed...
SEC-backed guidance on clinical trial data from China
A U.S. House spending committee advanced language that would require a ban on using Chinese clinical trial data in future FDA drug applications, signaling deep congressional concerns about...