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Latest Biotech News

FDA on edge: leadership churn threatens agency stability

December 22, 2025

The Food and Drug Administration is facing an acute personnel crisis that has left the agency operationally fragile heading into 2026. STAT reports that the FDA has cycled through five leaders of...

U.S. vaccine schedule overhaul: federal plan to drop several childhood shots

December 22, 2025

U.S. officials are reportedly preparing to overhaul the childhood immunization schedule to more closely match Denmark, a move that would drop or change recommendations for multiple routine...

Cytokinetics wins FDA nod — Myqorzo enters hypertrophic cardiomyopathy market

December 22, 2025

The FDA approved Cytokinetics’ Myqorzo, marking the first regulatory clearance in the company’s history and creating a direct market confrontation with Bristol Myers Squibb’s Camzyos. Coverage...

Samsung Biologics expands U.S. CDMO capacity with GSK plant buy

December 22, 2025

Samsung Biologics agreed to acquire a U.S. drug production facility from GSK for $280 million, a deal that expands the contract development and manufacturing organization’s footprint in North...

Federal research freezes cost $1.5B — NIH grants halted in 2025

December 22, 2025

Federal actions in 2025 froze multiple NIH operations and canceled more than $1.5 billion in grants, according to reporting collated from affected researchers and agencies. The Trump...

Fruquintinib plus sintilimab shows activity in advanced endometrial cancer

December 22, 2025

A multicenter Phase Ib/II trial reported that the VEGFR inhibitor fruquintinib combined with the PD-1 inhibitor sintilimab produced clinical activity in advanced, mismatch-repair proficient...

Antisense oligonucleotide rescues SMA developmental defects in organoids

December 22, 2025

Researchers reported in Nature Communications that targeted antisense oligonucleotide (ASO) therapy reversed developmental defects in spinal muscular atrophy (SMA) organoid models. The study...

Antivirals cut post-COVID cardiovascular risk — target trial emulation finds benefit

December 22, 2025

A large target trial emulation published in Nature Communications found that outpatient antiviral treatments—nirmatrelvir/ritonavir (Paxlovid) and molnupiravir—were associated with reduced...

KGLGANSynergy: graph attention model predicts drug synergy

December 22, 2025

Researchers unveiled KGLGANSynergy, a knowledge-graph and attention-network framework that predicts drug synergy with improved accuracy over prior models. The method integrates local and global...

Biotech IPOs may return in 2026 — VC predicts as sector stocks recover

December 22, 2025

Atlas Venture partner Bruce Booth predicted on STAT’s podcast that biotech IPO activity will rebound in 2026 after a two-year drought, forecasting a wave of public listings as market appetite...

Cytokinetics wins FDA nod – Myqorzo to compete with Bristol Myers

December 22, 2025

The FDA granted approval to Cytokinetics’ heart drug Myqorzo, marking the first regulatory clearance in the company’s history and introducing a direct competitor to Bristol Myers Squibb’s Camzyos....

Antivirals cut post‑COVID cardiac risk – target trial emulation shows benefit

December 22, 2025

A Nature Communications target‑trial emulation led by Guo, Wei, Lin and colleagues showed that antiviral treatments nirmatrelvir/ritonavir and molnupiravir reduced the risk of cardiovascular...

Antisense oligo reverses SMA defects in organoids — translational step

December 22, 2025

Researchers reported in Nature Communications that a targeted antisense oligonucleotide (ASO) therapy reversed developmental defects in spinal muscular atrophy (SMA) organoid models. The study...

Fruquintinib plus sintilimab shows activity in pMMR endometrial cancer

December 22, 2025

A multicenter Phase Ib/II single‑arm trial reported activity for the combination of fruquintinib and sintilimab in advanced mismatch‑repair proficient (pMMR) endometrial cancer. Investigators...

Multivalency and FcγRIIB engagement amplify anti‑CD27 immunotherapy

December 22, 2025

A Nature Communications study demonstrated that engineering anti‑CD27 agonists for multivalency and engagement of the inhibitory FcγRIIB receptor substantially enhances antitumor activity. The...

Graph‑attention AI predicts drug synergy: KGLGANSynergy unveiled

December 22, 2025

Researchers published KGLGANSynergy, a knowledge‑graph and attention‑based framework that improves prediction of drug synergy across compound pairs. The model integrates local and global attention...

New LRRK2 variant P1446L drives neurodegeneration via microglial inflammation

December 22, 2025

Investigators identified a novel LRRK2 mutation (P1446L) that promotes dopaminergic neuron loss through microglia‑driven inflammation and apoptosis, according to a paper in npj Parkinson’s...

MINFLUX maps cardiac ryanodine receptor in 3D in living cells

December 22, 2025

Researchers applied MINFLUX super‑resolution microscopy to resolve the subunit architecture and three‑dimensional orientation of cardiac ryanodine receptors (RyR) inside living cells. The study...

Autophagy sorts mitochondria to define CD8+ T cell fate and division

December 22, 2025

Teams at the Max Delbrück Center and University of Oxford reported in Nature Cell Biology that autophagy regulates mitochondrial inheritance during asymmetric CD8+ T cell division, directing...

Antibiotic exposure associated with altered breast cancer survival in population study

December 22, 2025

A large population‑based cohort study from England and Wales, published in Nature Communications, found associations between antibiotic use and breast cancer survival outcomes. The analysis...