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Immunotherapy efficacy holds up: Pembrolizumab adds sustained survival in endometrial cancer
Long-term follow-up from the NRG Oncology GY018 Phase 3 trial reinforced survival benefits from adding pembrolizumab to standard chemotherapy for advanced or recurrent endometrial cancer. The...
Allogene CEO succession and leadership reset at a cell-therapy maker
Allogene Therapeutics named Zachary Roberts as the next president and CEO, with plans for him to succeed David Chang on July 1. The shift comes after Chang co-founded the company and led it for...
Clinical-stage win: BMS’ mezigdomide doubles PFS in Phase 3 myeloma readout
Bristol Myers Squibb disclosed Phase 3 results for mezigdomide in the SUCCESSOR-2 study, showing a substantial progression-free survival improvement when added to carfilzomib and dexamethasone in...
FDA approval expansion: Tempus wins tumor-only use for xT CDx profiling
Tempus AI received FDA approval for a tumor-only indication for its xT CDx next-generation sequencing assay. The authorization expands Tempus’ 648-gene solid tumor platform so it can be used...
Biotech financing: CareTria buys CaryHealth to build AI direct-to-patient pharmacy platform
CareTria acquired CaryHealth to create an integrated AI-powered direct-to-patient pharmacy platform aimed at streamlining prescription-to-therapy initiation and adherence. The combined system is...
Regulatory and drug development in China: NMPA data protection rules finalize
China’s National Medical Products Administration issued final implementation measures for drug trial data protection, moving the country closer to alignment with international pharmaceutical IP...
FDA gets a new user fee deal in the White House review window
The White House is reviewing a new prescription drug user fee package agreement reached between the FDA and the biopharma industry for the years 2028 through 2032. The arrangement, under White...
Clinical diagnostics: NY approval clears Delfi’s blood-based lung cancer LDT across the U.S.
Delfi Diagnostics received New York State Department of Health approval to offer its FirstLook Lung laboratory-developed lung cancer screening test. With the approval, Delfi can market its...
Immunotherapy for advanced melanoma regains FDA path
Replimune said it has reached alignment with the FDA to resubmit its twice-rejected advanced melanoma biologic, RP-1 (vusolimogene oderparepvec), for FDA review. The company is pursuing approval...
BMS’ CELMoD mezigdomide delivers another Phase 3 win in multiple myeloma
Bristol Myers Squibb disclosed Phase 3 results from the SUCCESSOR-2 study showing its cereblon E3 ligase modulator mezigdomide (MeziKd) nearly doubles median progression-free survival in relapsed...
Pfizer and Innovent expand multibillion-dollar antibody-drug conjugate and multispecific pipeline
Pfizer announced a wide-ranging oncology collaboration with Innovent Biologics covering 12 early-stage and de novo antibody-drug conjugate and multispecific programs. The deal includes $650...
China issues finalized drug trial data protection rules
China’s National Medical Products Administration issued final implementation measures for drug trial data protection, positioning the country closer to global norms for pharmaceutical IP. The...
GSK bepirovirsen delivers functional cure signal in Phase 3 chronic hepatitis B
GSK reported Phase 3 results for bepirovirsen, an antisense oligonucleotide in development for chronic hepatitis B, describing a functional cure rate of 19% across two trials after discontinuation...
AbbVie wins FDA approval for Decnupaz in BPDCN
AbbVie received FDA approval for Decnupaz (pivekimab sunirine), a CD123-targeting antibody-drug conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The approval...
Tempus gains FDA approval for tumor-only version of xT CDx
Tempus AI said the FDA approved a tumor-only indication for its xT CDx 648-gene next-generation sequencing platform, expanding flexibility when matched normal tissue is unavailable. The assay is...
Diagnostics expansion: Delfi wins New York approval for blood-based lung cancer LDT
Delfi Diagnostics said the New York State Department of Health approved its FirstLook Lung laboratory-developed test, enabling the company to offer its cfDNA-based liquid biopsy screening assay...
Biotech leadership change at Allogene signals strategy reset
Allogene Therapeutics appointed Zachary Roberts, its EVP of R&D and CMO, to succeed co-founder David Chang as president and CEO. Roberts will start July 1, while Chang will remain on the board...
Clinical genomics and diagnostics: Labcorp study tests multigene panels in colorectal cancer
Labcorp partnered with ACTO to launch a clinical trial evaluating the impact of multigene panel testing on colorectal cancer patient care and on driving testing among at-risk relatives. Labcorp...
Big pharma licensing and China R&D scale-up
Pfizer and Innovent Biologics escalated China-linked oncology dealmaking with a multi-drug collaboration spanning 12 early-stage and de novo antibody programs. Pfizer will pay Innovent $650...
Multiple myeloma: next-gen CELMoD efficacy at ASCO
Bristol Myers Squibb reported Phase 3 SUCCESSOR-2 results for mezigdomide (MeziKd), showing a 52% reduction in the risk of disease progression or death versus carfilzomib plus dexamethasone alone....