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FDA clears Zycubo — first treatment for Menkes disease
The U.S. Food and Drug Administration approved Zycubo (copper histidinate, CUTX‑101) as the first therapy for Menkes disease, a lethal pediatric copper‑absorption disorder. Sentynl Therapeutics,...
FDA extends Travere review — label expansion for sparsentan delayed
The FDA extended its review of Travere Therapeutics’ supplemental NDA for sparsentan (FILSPARI) in focal segmental glomerulosclerosis (FSGS), setting a new PDUFA target action date in April 2026....
Rage Bio starts clinic work — inhaled splice‑switching oligo for COPD
Rage Biotech opened first‑in‑human testing of RB‑042, an inhaled splice‑switching oligonucleotide for COPD and inflammatory lung disease, and announced AU$29 million (US$19.4 million) in Series A...
FDA signals CGT flexibility — packaging, manufacturing moves follow
The FDA’s Center for Biologics Evaluation and Research announced steps to modernize and provide flexibility in chemical, manufacturing and control expectations for cell and gene therapies (CGTs),...
Illumina’s Billion Cell Atlas: Largest perturbation dataset to turbocharge AI drug discovery
Illumina unveiled the Billion Cell Atlas at the J.P. Morgan Healthcare Conference, launching what it calls the world’s largest genome‑wide genetic perturbation dataset designed to accelerate...
NVIDIA and pharma co‑invest: $1B AI lab with Lilly and direct partnerships to embed AI across discovery
NVIDIA announced a wave of drug‑discovery partnerships at JP Morgan, including a five‑year, up‑to‑$1 billion co‑innovation AI lab with Eli Lilly and alliances with Thermo Fisher and diagnostics...
FDA clears first Menkes therapy: Zycubo approved for rare copper‑absorption disease
The U.S. Food and Drug Administration approved Zycubo (copper histidinate, CUTX‑101) as the first approved treatment for Menkes disease, a rare pediatric disorder of copper absorption that causes...
Eikon Therapeutics eyes Nasdaq IPO — oncology pipeline and PARP programs in focus
Eikon Therapeutics filed with the SEC indicating it is considering a Nasdaq IPO to accelerate development of a multi‑program oncology pipeline. The California biotech—backed by more than $1.1...
AbbVie clinches MFN pricing deal and ties it to major US manufacturing commitments
AbbVie reached a most‑favored‑nation (MFN) pricing agreement with the White House and publicly signaled a sweeping manufacturing investment to accompany the pact. Under terms reported at the J.P....
Tahoe, Arc Institute and Biohub commit to a massive virtual‑cell perturbation dataset
Tahoe Therapeutics, the Arc Institute and the Biohub announced a joint initiative to generate a large, perturbation‑rich single‑cell dataset to accelerate virtual cell modeling. The partners...
MRD and liquid‑biopsy players scale: Precede raises cash as Natera expands Signatera
Precede Biosciences raised $83.5 million in Series B financing and a $20 million credit facility to scale its liquid‑biopsy platform for pharma partnerships, focusing on genome‑wide expression of...
Automation and regulatory flexibility aim to ease CGT scale‑up bottlenecks
Trenchant Biosystems released prototype data for its AutoCell automated cell‑and‑gene therapy (CGT) manufacturing platform, reporting up to seven‑fold increases in gene‑modified cell yield and...
Proxima raises $80M seed to apply AI to proximity‑modulating drug design
Proxima (formerly VantAI), a Roivant‑backed drug discovery firm, closed an oversubscribed $80 million seed round to develop AI‑driven proximity‑modulating therapeutics targeting protein...
PanMAN compressive pangenomics: new data structure to scale genome‑wide analyses
Engineers at UC San Diego published PanMAN, a new compressive pangenome data structure and file format that enables pangenomic analysis at previously infeasible scales by encoding...
Illumina unveils Billion Cell Atlas: AI models get drug-discovery map
Illumina announced the launch of its Billion Cell Atlas, a genome‑wide genetic perturbation dataset designed to accelerate AI-driven drug discovery. The company said the project will scale to one...
Nvidia and Lilly commit $1B: AI co‑innovation lab—partnerships multiply
Nvidia and Eli Lilly announced a five‑year partnership to create a Co‑Innovation AI Lab backed by up to $1 billion to accelerate drug discovery through large‑scale compute and model development....
AbbVie pays $650M upfront for PD‑1/VEGF bispecific: up to $5.6B
AbbVie signed an exclusive license to develop, manufacture and commercialize RC148, a PD‑1/VEGF‑targeted bispecific antibody developed by RemeGen, paying $650 million upfront and agreeing...
Novartis licenses amyloid and peptide assets: $165M upfront for SciNeuro program
Novartis announced two global licensing and collaboration agreements, including a deal with SciNeuro Pharmaceuticals for a de novo anti‑amyloid beta antibody program targeting Alzheimer’s disease....
FDA clears Zycubo as first Menkes treatment: PRV, commercialization rights detailed
The U.S. FDA approved Zycubo (copper histidinate, CUTX‑101) as the first treatment for Menkes disease, a fatal pediatric disorder of copper absorption. The approval granted Sentynl Therapeutics a...
Trenchant claims AutoCell prototype slashes CGT timelines and cost
Trenchant Biosystems released internal and external validation data for its AutoCell automated CGT manufacturing prototype, reporting a seven‑fold increase in gene‑modified cell yield, a potential...