How Insilico Medicine’s Virtual Aging Cell could bring biological time into AI drug discovery
Insilico Medicine is building an age-aware Virtual Aging Cell for drug discovery, but experimental validation will determine its real scientific value.
Pharma & Biotech
Pharma & Biotech
Phanes Therapeutics advances CLDN18.2 and CD47 bispecific spevatamig in biliary tract cancer
FDA Fast Track gives spevatamig a faster regulatory path in biliary tract cancer as Phanes advances its Phase 2 and pembrolizumab strategy.
Pharma & Biotech
Aurisco passed an FDA inspection for inclisiran sodium, but the bigger story is what comes next for generic oligonucleotides
Aurisco’s FDA inspection for inclisiran sodium puts generic oligonucleotide manufacturing closer to a crucial regulatory and commercial test.
Medical Devices & Diagnostics
Nanochon can now test Chondrograft in Panama, but five patients could decide what happens next
Nanochon gains Panama authorization for a five-patient Chondrograft study as its cartilage implant moves deeper into first-in-human testing.
Pharma & Biotech
Fate Therapeutics starts potentially registrational FT819 trial in lupus nephritis
Fate Therapeutics has treated the first participant in RECLAIM-LN, a Phase 2 study evaluating its off-the-shelf CD19-directed CAR T-cell candidate FT819 in people with refractory moderate-to-severe lupus nephritis. The company disclosed the trial initiation on August 14, 2026, saying the first participant received FT819 in an outpatient setting and was discharged on the same day.
Pharma & Biotech
Rezatapopt Phase 2 enrollment completes as PMV targets 2027 ovarian cancer NDA
Rezatapopt completes key Phase 2 enrollment as PMV targets a Q1 2027 accelerated approval filing in TP53 Y220C ovarian cancer.
Medical Devices & Diagnostics
Lantheus adds TAUKLARIFY to Alzheimer’s imaging toolkit after FDA approval
FDA approves TAUKLARIFY for tau PET imaging in Alzheimer’s evaluation. See how Lantheus’ new tracer fits into the evolving diagnostic market.
Pharma & Biotech
NervGen takes small but encouraging NVG-291 dataset into a pivotal chronic tetraplegia trial
NVG-291 Phase 3 screening starts in September as NervGen targets hand-function recovery in chronic tetraplegia. See what RESTORE must prove.
Pharma & Biotech
Off-the-shelf FT819 moves into Phase 2 lupus nephritis trial with outpatient dosing
FT819 enters a potentially registrational lupus nephritis trial with outpatient same-day dosing. See why Fate’s off-the-shelf CAR T model matters.
Pharma & Biotech
FDA clears denifanstat Phase 3 trial as Sagimet targets once-daily oral acne treatment
FDA clears Sagimet’s 800-patient denifanstat Phase 3 acne trial after positive China data. Read why the U.S. study could reshape its outlook.