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

Jane Aubrey September 11, 2026September 11, 2026

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

Jane Aubrey September 10, 2026September 10, 2026

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

Jane Aubrey September 9, 2026September 9, 2026

Rentosertib’s Aging-Clock Study Is a Biomarker Signal, Not Evidence That a Drug Reverses Human Aging

Jane Aubrey September 8, 2026September 8, 2026

Clover’s Phase 2 Combination-Vaccine Data Are Encouraging. They Are Not Yet an Efficacy Verdict.

Jane Aubrey September 7, 2026September 7, 2026

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Biotechnology

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

The FDA has expanded the accelerated approval of sevabertinib, marketed as Hyrnuo, for adults with…

Jane Aubrey September 11, 2026September 11, 2026
Biotechnology

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

BridgeBio has reported new exploratory analyses from PROPEL 3, its Phase 3 study of oral…

Jane Aubrey September 10, 2026September 10, 2026
Biotechnology

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

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

Jane Aubrey September 9, 2026September 9, 2026

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Biotechnology

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

Jane Aubrey September 11, 2026September 11, 2026
Biotechnology

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

Jane Aubrey September 10, 2026September 10, 2026
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…

Rentosertib’s Aging-Clock Study Is a Biomarker Signal, Not Evidence That a Drug Reverses Human Aging
Biotechnology

Rentosertib’s Aging-Clock Study Is a Biomarker Signal, Not Evidence That a Drug Reverses Human Aging

Jane AubreySeptember 8, 2026September 8, 2026

Insilico Medicine has published an analysis of its Phase IIa idiopathic pulmonary fibrosis, or IPF, data in which six proteomic…

Clover’s Phase 2 Combination-Vaccine Data Are Encouraging. They Are Not Yet an Efficacy Verdict.
Biotechnology

Clover’s Phase 2 Combination-Vaccine Data Are Encouraging. They Are Not Yet an Efficacy Verdict.

Jane AubreySeptember 7, 2026September 7, 2026

Clover Biopharmaceuticals has reported preliminary Phase 2 data for two respiratory combination-vaccine candidates aimed at older adults: SCB-1022, targeting RSV…

FDA’s Zanvastro Approval Creates a First Disease-Targeted Option for Alexander Disease
Biotechnology

FDA’s Zanvastro Approval Creates a First Disease-Targeted Option for Alexander Disease

Jane AubreySeptember 4, 2026September 4, 2026

The U.S. Food and Drug Administration has approved Zanvastro, or zilganersen, for pediatric and adult patients with Alexander disease. The…

Ultragenyx’s Aspire Readout Shows Why Phase 3 Evidence Still Decides Rare-Disease Programs
Healthcare

Ultragenyx’s Aspire Readout Shows Why Phase 3 Evidence Still Decides Rare-Disease Programs

Jane AubreySeptember 3, 2026September 3, 2026

Ultragenyx has reported that its Phase 3 Aspire study of apazunersen, also called GTX-102, in Angelman syndrome did not meet…

Batten-1’s Phase 3 Submission Puts a Rare-Disease Trial Design Under the Microscope
Biotechnology

Batten-1’s Phase 3 Submission Puts a Rare-Disease Trial Design Under the Microscope

Marcus ChenSeptember 2, 2026September 2, 2026

THX Pharma, the Beyond Batten Disease Foundation and Biocodex have submitted regulatory applications to begin Batten-1-02, a Phase 3 study…

BioVie’s Long COVID Trial Completion Moves Bezisterim to the Interpretation Stage
Biotechnology

BioVie’s Long COVID Trial Completion Moves Bezisterim to the Interpretation Stage

Jane AubreySeptember 1, 2026September 1, 2026

BioVie has completed the last on-treatment visit in its ADDRESS-LC Phase 2 study of bezisterim for neurological symptoms associated with…

COMIRNATY XFG Approval Narrows the Conversation to Variant Match, Eligibility and Delivery
Biotechnology

COMIRNATY XFG Approval Narrows the Conversation to Variant Match, Eligibility and Delivery

Jane AubreyAugust 31, 2026August 31, 2026

Pfizer and BioNTech say FDA has approved the supplemental biologics license application for a 2026–27 COMIRNATY formulation targeting the XFG…

Lisraya Gives Dermatomyositis Its First FDA-Approved Oral Treatment Option
Healthcare

Lisraya Gives Dermatomyositis Its First FDA-Approved Oral Treatment Option

Jane AubreyAugust 28, 2026August 28, 2026

FDA has approved Lisraya, or brepocitinib, tablets for adults with dermatomyositis, creating the first FDA-approved oral treatment option for this…

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