Get the Daily Brief
Latest Biotech News
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...
FDA committee scrutiny around AstraZeneca’s camizestrant strategy
FDA oncology advisers voted against using AstraZeneca’s oral SERD camizestrant in a new clinical setting proposed for patients with HR+/HER2− metastatic breast cancer. According to the ODAC panel...
Axsome expands Alzheimer’s agitation label after FDA approval
The FDA approved Axsome Therapeutics’ Auvelity (AXS-05) for Alzheimer’s disease agitation, expanding the therapy’s label beyond major depressive disorder. The approval gives Auvelity access to a...
FDA leadership transition at CBER
Vinay Prasad stepped down as head of the FDA’s Center for Biologics Evaluation and Research, with his deputy Katherine Szarama taking over in an acting capacity while the search for a permanent...
Moderna seeks FDA talks on restoring broader use of COVID vaccines
Moderna said it is in discussions with the FDA to provide post-marketing data on its COVID-19 vaccines, aiming to restore broader use after FDA leaders narrowed the label last year. The company’s...
Gene therapy manufacturing and platform strategy: AAV and non-viral delivery focus
New research and industry commentary converge on the delivery problem in cell and gene therapy—specifically how improvements to AAV platforms and alternative delivery methods aim to address...
Biopharma dealmaking and portfolio reshaping after clinical signals
Johnson & Johnson is discontinuing two CAR-T programs in B-cell lymphoma—JNJ-9530 and JNJ-4496—citing an evolving treatment landscape and portfolio priorities after phase 1 and 1/2...
Biopharma IPO momentum continues with upsized offerings
Three biotechs returned to the public markets with upsized IPOs totaling more than $850 million, extending a 2026 wave of large equity raises. Seaport Therapeutics and Hemab Therapeutics debuted...
Genomics pioneer J. Craig Venter dies at 79
J. Craig Venter, the genomics pioneer who helped lead the private sequencing effort for the human genome and later founded and built biotech companies including the J. Craig Venter Institute, died...