Get the Daily Brief
Latest Biotech News
Big Pharma doubles down on China-based ADC and multispecific discovery pipelines
Pfizer and Innovent Biologics announced a broad multi-drug R&D collaboration for antibody-drug conjugates and multispecific antibodies across 12 oncology programs, with Innovent receiving $650...
Multiple myeloma: CELMoD-based regimen doubles PFS in Phase 3 SUCCESSOR-2
Bristol Myers Squibb disclosed Phase 3 SUCCESSOR-2 results for mezigdomide (MeziKd) in relapsed or refractory multiple myeloma, reporting a 52% reduction in risk of disease progression or death...
Multiple myeloma pipeline: successor program mezigdomide extends into a published PFS headline
Bristol Myers Squibb’s mezigdomide continues to build toward regulatory and label strategy after it reported SUCCESSOR-2 success, reinforcing the company’s push for next-generation multiple...
Oncology trials at ASCO: ovarian cancer AD C and bladder cancer competition builds
Gilead updated clinical data at ASCO on TUB-040, its antibody-drug conjugate tied to the Tubulis buyout, with the latest readout presented as supportive of the program’s continued development in...
Diagnostic shift: Tempus wins FDA approval for tumor-only sequencing for xT CDx
Tempus AI secured FDA approval for a tumor-only indication for its xT CDx next-generation sequencing assay, expanding how the 648-gene platform can be used for molecular profiling of solid tumors....
Regenerative and community clinical integration: CDL-Cleveland launches direct hospital innovation hub
Creative Destruction Lab launched CDL-Cleveland with University Hospitals and Case Western Reserve University, creating a direct clinical integration platform aimed at moving biomedical startups...
Cell therapy leadership change: Allogene CEO David Chang steps down
Allogene Therapeutics said Zachary Roberts will succeed David Chang as president and CEO after Chang’s eight-year tenure at the off-the-shelf CAR-T company. The move is set to take effect July 1...
CAR-T platform development: Allogene swap in CMO role after CEO transition
Following the announcement of David Chang’s exit, Allogene’s executive changes are continuing with the company repositioning leadership around its CMO and R&D functions. The update places Zachary...
Mega-deal: Pfizer and Innovent expand into ADCs and multispecifics
Pfizer struck a broad oncology collaboration with Innovent Biologics to develop 12 antibody-drug conjugates and multispecific antibody programs, anchored by early-stage discovery from Innovent and...
FDA resubmission attempt: Replimune eyes RP-1 melanoma after biotech leadership churn
Replimune said it reached alignment with the U.S. FDA to resubmit its melanoma biologic RP-1 (vusolimogene oderparepvec) after two prior rejections. The company plans to file the biologics license...
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...