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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

Editor Choice

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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
Eli Lilly Escalates Obesity War, Offers Early Access to Next-Gen GLP-1 Retatrutide
Lifestyle

Eli Lilly Escalates Obesity War, Offers Early Access to Next-Gen GLP-1 Retatrutide

Jane AubreyAugust 10, 2026August 10, 2026

The battle for dominance in the lucrative obesity drug market is entering a new and aggressive phase. Eli Lilly has…

FDA Expands Casgevy Gene Therapy Approval to Children as Young as Two with Sickle Cell Disease
Genetics

FDA Expands Casgevy Gene Therapy Approval to Children as Young as Two with Sickle Cell Disease

Jane AubreyAugust 8, 2026August 8, 2026

In a monumental milestone for pediatric hematology, the U.S. Food and Drug Administration (FDA) has expanded the approval of Casgevy,…

Third Time’s the Charm: FDA Finally Approves Replimune’s Melanoma Therapy
Biotechnology

Third Time’s the Charm: FDA Finally Approves Replimune’s Melanoma Therapy

Jane AubreyAugust 7, 2026August 7, 2026

In a testament to clinical persistence, the U.S. Food and Drug Administration (FDA) has officially approved Replimune’s novel melanoma therapy,…

Merck’s Q2 Earnings: Oncology Dominance Masks Looming Patent Cliff Anxiety
Pharma

Merck’s Q2 Earnings: Oncology Dominance Masks Looming Patent Cliff Anxiety

Jane AubreyAugust 6, 2026August 6, 2026

Merck & Co. (MRK) reported its second-quarter 2026 financial results, delivering a performance that simultaneously showcased the unmatched commercial power of…

Pfizer’s Q2 Earnings: Non-COVID Growth Drives Guidance Raise Amid Operational Efficiency Push
Pharma

Pfizer’s Q2 Earnings: Non-COVID Growth Drives Guidance Raise Amid Operational Efficiency Push

Jane AubreyAugust 5, 2026August 5, 2026

Pfizer Inc. (PFE) reported its second-quarter 2026 financial results, delivering a performance that underscored the company’s successful pivot away from its…

August FDA Action: Pluvicto Expands Reach as Moderna Awaits Landmark Flu Vaccine Decision
Biotechnology

August FDA Action: Pluvicto Expands Reach as Moderna Awaits Landmark Flu Vaccine Decision

Jane AubreyAugust 3, 2026

The first week of August 2026 is shaping up to be a defining period for the biotechnology and pharmaceutical sectors,…

FDA Advisory Panel Backs Replimune’s RP1 for Advanced Melanoma Ahead of August Decision
Biotechnology

FDA Advisory Panel Backs Replimune’s RP1 for Advanced Melanoma Ahead of August Decision

Jane AubreyAugust 2, 2026

The biotechnology sector is closely watching the regulatory landscape this August, with several key Prescription Drug User Fee Act (PDUFA)…

Healthcare Progress Is Becoming a Standards-Governed Interoperability Business
Healthcare

Healthcare Progress Is Becoming a Standards-Governed Interoperability Business

Jane AubreyAugust 1, 2026August 1, 2026

Not every important healthcare development arrives as a new drug approval or a dramatic clinical-data release. Sometimes the real bottleneck…

Regenerative Medtech Is Becoming a Scale-and-Channel Consolidation Business
Biohacking

Regenerative Medtech Is Becoming a Scale-and-Channel Consolidation Business

Jane AubreyJuly 30, 2026July 30, 2026

The most revealing healthcare development of the last two days may not be a new trial result or a new…

Cell Therapy Is Entering a Harsher Evidence-Governance Era
Biotechnology

Cell Therapy Is Entering a Harsher Evidence-Governance Era

Jane AubreyJuly 29, 2026July 29, 2026

One of the most revealing biotech developments of the last forty-eight hours was not a clinical breakthrough but a regulatory…

Diagnostics Is Becoming a Distributed-Sampling Infrastructure Business
Testing

Diagnostics Is Becoming a Distributed-Sampling Infrastructure Business

Marcus ChenJuly 28, 2026July 28, 2026

One of the more revealing healthcare developments of the last forty-eight hours did not come from a trial readout or…

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