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Category: Biotechnology

FDA Brings PD-L1 Blockade Into Resected Stage III dMMR Colon Cancer—With DFS Evidence, Not Yet an OS Answer
Biotechnology

FDA Brings PD-L1 Blockade Into Resected Stage III dMMR Colon Cancer—With DFS Evidence, Not Yet an OS Answer

Jane AubreyOctober 9, 2026October 9, 2026

The FDA has approved atezolizumab with a fluoropyrimidine and oxaliplatin as adjuvant treatment for completely resected stage III deficient mismatch…

FDA Approves a Pediatric Valve That Can Expand With Growth—With Durability Still to Be Earned.
Biotechnology

FDA Approves a Pediatric Valve That Can Expand With Growth—With Durability Still to Be Earned.

Jane AubreyOctober 2, 2026October 2, 2026

The FDA’s October 1 approval of Edwards Lifesciences’ AUTUS Size-Adjustable Valve is a real pediatric-device inflection point, not simply a…

NeuroAI Needs an Error Budget, Not a Vibe Check
Biotechnology

NeuroAI Needs an Error Budget, Not a Vibe Check

Ralph SunOctober 1, 2026October 1, 2026

NeuroAI is often framed as whether a system can “understand” a person. That framing is too loose for a product…

Octant Takes an Oral Rhodopsin Corrector Into Patients—But the Human Evidence Clock Has Just Started.
Biotechnology

Octant Takes an Oral Rhodopsin Corrector Into Patients—But the Human Evidence Clock Has Just Started.

Jane AubreySeptember 25, 2026September 25, 2026

Octant has reached a meaningful but early clinical threshold in inherited retinal disease. The company announced first-patient dosing in the…

ELPIS II’s Primary Endpoint Miss Is the Headline. The Harder Question Is What Its Exploratory Signals Can, and Cannot, Tell Families Facing HLHS.
Biotechnology

ELPIS II’s Primary Endpoint Miss Is the Headline. The Harder Question Is What Its Exploratory Signals Can, and Cannot, Tell Families Facing HLHS.

Jane AubreySeptember 17, 2026September 17, 2026

Longeveron’s September 16 readout from ELPIS II provides a demanding but important lesson in clinical-trial interpretation. The Phase 2b study…

SKY-0515’s Fifteen-Month Huntington’s Dataset Has a Stronger Signal Than Typical Early Readouts. Its External-Control Design Still Sets the Standard for Caution.
Biotechnology

SKY-0515’s Fifteen-Month Huntington’s Dataset Has a Stronger Signal Than Typical Early Readouts. Its External-Control Design Still Sets the Standard for Caution.

Jane AubreySeptember 17, 2026September 17, 2026

Skyhawk Therapeutics’ September 15 release on SKY-0515 offers an unusually detailed early clinical picture for Huntington’s disease. The company reported…

XRPL BatchV1_1 Is Supported but Still Disabled. That Is Exactly Why Integrators Must Separate Readiness From Activation
Biotechnology

XRPL BatchV1_1 Is Supported but Still Disabled. That Is Exactly Why Integrators Must Separate Readiness From Activation

Jane AubreySeptember 15, 2026September 15, 2026

Amgen announced on September 14 that the FDA approved an update to the prescribing information for IMDELLTRA, or tarlatamab-dlle, that…

NeuroAI Meets Physical AI: Why the Human Side of Robotics May Become Its Next Data Layer
Biotechnology

NeuroAI Meets Physical AI: Why the Human Side of Robotics May Become Its Next Data Layer

Jane AubreySeptember 14, 2026September 14, 2026

BrainLayer is applying a NeuroAI-enabled Human Model to Physical AI, with an evidence-first approach to human-state data, robotics recovery, and…

FDA Expands Sevabertinib’s Accelerated Approval in HER2-Mutant NSCLC. The Response Data Are Encouraging, but Confirmation Still Matters
Biotechnology

FDA Expands Sevabertinib’s Accelerated Approval in HER2-Mutant NSCLC. The Response Data Are Encouraging, but Confirmation Still Matters

Jane AubreySeptember 11, 2026September 11, 2026

The FDA has expanded the accelerated approval of sevabertinib, marketed as Hyrnuo, for adults with locally advanced or metastatic non-squamous…

BridgeBio’s PROPEL 3 Update Broadens the Infigratinib Story Beyond Height. The New Results Remain Exploratory.
Biotechnology

BridgeBio’s PROPEL 3 Update Broadens the Infigratinib Story Beyond Height. The New Results Remain Exploratory.

Jane AubreySeptember 10, 2026September 10, 2026

BridgeBio has reported new exploratory analyses from PROPEL 3, its Phase 3 study of oral infigratinib in children with achondroplasia.…

Leyden Labs’ RIG-101 Clears an Early Safety and Biomarker Hurdle. Phase 2 Must Now Show Clinical Protection.
Biotechnology

Leyden Labs’ RIG-101 Clears an Early Safety and Biomarker Hurdle. Phase 2 Must Now Show Clinical Protection.

Jane AubreySeptember 9, 2026September 9, 2026

Leyden Laboratories has reported positive Phase 1 findings for RIG-101, an investigational intranasal innate-immune modulator intended to strengthen antiviral defenses…

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