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FDA pushes tighter scrutiny of China-origin early data
The FDA signaled increased scrutiny for early-stage clinical data originating in China, acknowledging concerns that have been raised by regulators and lawmakers. The agency stopped short of...
Radioligand approvals: first generic and renewed competitive pressure
The FDA cleared a first “radioligand equivalent” generic to Novartis’ Lutathera, intensifying competition in a market previously dominated by brand leadership. Curium announced FDA approval of its...
GSK- Chimagen trispecific bet for multiple myeloma
GSK agreed to acquire global rights to a trispecific T-cell engager from Chimagen Biosciences, committing up to $750 million to secure a Phase 1-ready program aimed at multiple myeloma. The asset...
Vera seeks full FDA approval after durable IgAN results
Vera Therapeutics said its recently approved IgA nephropathy therapy, Trutakna, delivered final two-year Phase 3 results, including stabilization of kidney function and a reduced risk of...
Scholar Rock wins SMA FDA approval for Isembyld
The FDA approved Scholar Rock’s myostatin inhibitor apitegromab, marketed as Isembyld, for spinal muscular atrophy. The decision clears the therapy for use alongside existing targeted treatments...
Telix gets first glioma FET-PET imaging approval
The FDA approved Telix Pharmaceuticals’ Pixclara (floretyrosine F-18, 18F-FET), making it the first FDA-approved FET-PET imaging agent for glioma. Telix said the approval is also the first U.S....
Sionna Therapeutics cuts after cystic fibrosis setback
Sionna Therapeutics announced it is laying off 46% of its workforce as it pivots after an unexpected failure of a cystic fibrosis trial. The company said the workforce reduction is part of its...
Teitur Trophics peptide TT-P34 posts positive Phase I Parkinson’s signals
Teitur Trophics reported positive Phase I results for its therapeutic peptide TT-P34 in Parkinson’s disease, highlighting measurable central nervous system exposure and a favorable early safety...
Shingles after-pain linked to exosome-driven neuronal dysfunction
Researchers at the University of Colorado Anschutz reported evidence linking circulating exosomes to persistent nerve irritation and lingering pain after shingles, a condition known as...
Regulatory acceleration for early-stage trials
The FDA launched the final design of its Expedited IND Pilot and began accepting applications this week, aiming to shorten timelines from target selection to first-in-human studies. The program...
FDA greenlights first radioligand generic
The FDA approved Curium’s “radioligand equivalent” to Novartis’ Lutathera, establishing the first generic competitor in the radioligand category. The clearance sets up direct regulatory and...
Biologics regulation and drug-data scrutiny from China
The FDA signaled tighter scrutiny of early-stage data submitted from China, according to reporting that the agency is acknowledging concerns while stopping short of an outright ban. The shift...
Major CNS immunology platform funding and leadership change
Shennon Biotechnologies raised $12 million and appointed Cyril Konto as CEO to drive its TCELERATOR platform and oncology pipeline forward. The company said it is shifting from platform-building...
Big Pharma bets on trispecific T-cell engager for multiple myeloma
GSK committed up to $750 million to acquire global rights to Chimagen’s Phase 1-ready trispecific T-cell engager program for multiple myeloma. The deal expands GSK’s immuno-oncology pipeline with...
Trial pipeline: lung cancer ADC competition narrows
Phase III readouts at lung cancer meetings underlined the competitive pressure in the ADC space. Gilead’s Trodelvy (sacituzumab govitecan) plus pembrolizumab failed to meet primary goals in the...
Regulatory win in rare neuromuscular disease (SMA)
The FDA cleared Scholar Rock’s myostatin inhibitor apitegromab (branded Isembyld) for spinal muscular atrophy, including adults and children at least 2 years old who are receiving an SMN-targeted...
Biomarker-linked mechanistic neuroscience tool: Alzheimer’s microprotein atlas
Researchers at the Salk Institute built what they describe as the first microprotein atlas of the human frontal cortex in Alzheimer’s disease, mapping previously overlooked microproteins across...
Mechanistic immune-to-nerve signaling in post-shingles pain
A study from the University of Colorado Anschutz linked extracellular vesicles (exosomes) to persistent nerve irritation and lingering pain after shingles. Published in Annals of Neurology, the...
GSK doubles down on Chimagen with multiple-line ROS1 lung cancer asset move
GSK’s lung cancer strategy received a fresh data boost tied to its ROS1 pipeline. At the World Conference on Lung Cancer, GSK reported a 94% objective response rate in a predefined TKI-naive...
FDA clears first generic radioligand equivalent to Lutathera
The U.S. FDA approved Curium’s “radioligand equivalent” to Novartis’ Lutathera, marking the first generic radioligand clearance in the category. The decision sets up direct regulatory and...