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FDA approval - Rare kidney disease
Travere Therapeutics secured FDA approval for Filspari (sparsentan) as the first fully approved treatment for focal segmental glomerulosclerosis (FSGS). The approval expands a label that already...
Oncology dealmaking - radiopharmaceuticals
Regeneron and Telix announced a partnership to enter radiopharmaceuticals, pairing Regeneron’s VelocImmune antibody platform with Telix’s radiopharmaceutical development, manufacturing, and global...
Immuno-oncology - in vivo CAR T cell manufacturing
Cabaletta Bio disclosed that its investigational autologous CAR T therapy rese-cel has been manufactured using Cellares’ automated Cell Shuttle platform and dosed into the first two patients. The...
FDA - gene editing safety guidance
The FDA released draft guidance on how to assess safety risks in genome-edited gene therapies using next-generation sequencing and bioinformatics. The agency’s focus includes off-target editing...
FDA - clinical trial transparency enforcement
The FDA increased pressure on sponsors to report clinical trial results, sending reminders to more than 2,200 sponsors and researchers tied to over 3,000 clinical trials. The agency said it found...
Clinical trial breakthrough - pancreatic cancer RAS inhibition
Revolution Medicines reported “unprecedented” survival outcomes from its Phase 3 pancreatic cancer study of daraxonrasib, a targeted RAS inhibitor. In the trial, patients receiving daraxonrasib...
Biotech funding - single-cell functional assays
Lightcast raised $27 million to commercialize its Envisia platform for massively parallel droplet-based single-cell functional assays. The Cambridge, UK-based company plans to use the capital to...
Clinical oncology - CAR T immunology in lymphoma
Allogene reported interim Phase 3 “off-the-shelf” CAR T data showing strong minimal residual disease clearance in first-line consolidation large B-cell lymphoma. In the Alpha3 futility analysis,...
Regulatory reform - Phase I trial timelines
The FDA proposed a faster regulatory path for first-in-human (FIH) Phase I trials to boost US competitiveness, including a “clinical trial notification pathway” included in its 2027 budget...
AI in clinical development - real-world data expansion
Thermo Fisher expanded real-world data capabilities through a strategic collaboration with HealthVerity. The deal gives Thermo Fisher’s PPD clinical research business access to HealthVerity’s...
Oncology: Revolution Medicines’ daraxonrasib delivers major pancreatic cancer signal
Revolution Medicines reported that its KRAS(ON) inhibitor daraxonrasib hit prespecified endpoints in a pivotal Phase 3 trial in metastatic pancreatic ductal adenocarcinoma, extending survival...
Regulatory: FDA grants Travere Filspari approval for FSGS
The FDA expanded Travere Therapeutics’ label for Filspari (sparsentan), approving it as the first and only fully approved therapy for focal segmental glomerulosclerosis (FSGS). The decision adds a...
Radiopharma: Regeneron and Telix expand into next-generation targeted radiopharmaceuticals
Regeneron and Telix announced a collaboration to co-develop and co-commercialize next-generation radiopharmaceutical therapies and related diagnostics, marking Regeneron’s first entry into...
CAR-T manufacturing: Cellares’ Cell Shuttle produces the first rese-cel doses
Cellares said it has manufactured and enabled dosing of Cabaletta Bio’s investigational autologous CAR T therapy rese-cel (resecabtagene autoleucel) into the first two patients. The cells were...
Oncology pipeline funding: Oricell raises $110M pre-IPO to expand solid-tumor CAR T
Oricell Therapeutics raised $110 million in a pre-IPO round to expand its global footprint and advance a GPC3-targeted autologous CAR T therapy for liver cancer into registrational trial planning....
Biotech M&A: Eli Lilly acquires CrossBridge Bio for up to $300M to build ADC capabilities
Eli Lilly agreed to buy CrossBridge Bio, a Houston-based antibody-drug conjugate startup, for up to $300 million, as it adds technology aimed at improving next-generation ADC performance. The deal...
Clinical-stage oncology: Allogene’s “off-the-shelf” CAR-T posts early MRD signal in Phase 3
Allogene Therapeutics reported interim results from a pivotal Phase 2 Alpha3 trial in first-line consolidation large B-cell lymphoma, suggesting its allogeneic CAR T cemacabtagene ansegedleucel...
Funding: Lightcast raises $27M to commercialize single-cell functional assay platform
Lightcast raised $27 million to help commercialize its Envisia platform for massively parallel droplet-based single-cell functional assays. The Cambridge, UK-based company plans to use the funding...
Regulatory compliance and disclosure: FDA pushes clinical trial result reporting
The FDA sent reminders to more than 2,200 sponsors and investigators tied to over 3,000 clinical trials that may be delinquent in disclosing results on ClinicalTrials.gov. The agency’s action...
Biotech tools and automation: Fortrea launches AI trial technology suite
Fortrea rolled out an AI-powered clinical trial services suite built around its FIT platform, aiming to improve trial efficiency and reduce risk in execution. The CRO said the technology supports...