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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
The FDA Is Moving Upstream Into Factory Formation
Pharma

The FDA Is Moving Upstream Into Factory Formation

Jane AubreyJuly 2, 2026July 2, 2026

For decades, the drug industry treated regulation and manufacturing as sequential problems. Companies developed an asset, built or secured production…

Clinical-Trial Outsourcing Is Becoming a Biosecurity Diligence Problem
Pharma

Clinical-Trial Outsourcing Is Becoming a Biosecurity Diligence Problem

Marcus ChenJuly 1, 2026July 1, 2026

For years, the biopharma industry treated global clinical-trial geography as an execution question. Companies went where patient recruitment was faster,…

Biotech Buyers Are Paying for Cash-Flow Bridges, Not Just Science
Biotechnology

Biotech Buyers Are Paying for Cash-Flow Bridges, Not Just Science

Jane AubreyJune 30, 2026June 30, 2026

The most revealing biotech deal of the past two days is not really a science-acquisition story at all. It is…

Biopharma Is Paying for Assets That Rewire the Standard of Care
Pharma

Biopharma Is Paying for Assets That Rewire the Standard of Care

Jane AubreyJune 29, 2026June 29, 2026

The most interesting biotech deal of the day is not important because of its size alone. It is important because…

Life-Science Tools Are Being Valued Like Therapeutic Platforms
Lifestyle

Life-Science Tools Are Being Valued Like Therapeutic Platforms

Jane AubreyJune 28, 2026June 28, 2026

Biotech’s most revealing deal this week did not center on a drug asset, a phase 3 readout, or a late-stage…

Biotech Corridors Are Becoming Products of Their Own
Biotechnology

Biotech Corridors Are Becoming Products of Their Own

Jane AubreyJune 27, 2026June 27, 2026

Biotech hubs used to sell themselves with a familiar formula: good universities, venture capital, hospital systems, and a deep pool…

Rare Outbreaks Are Becoming Real-Time Clinical Platforms
Pathogens

Rare Outbreaks Are Becoming Real-Time Clinical Platforms

Jane AubreyJune 26, 2026June 26, 2026

One of the more consequential healthcare developments of the past two days has arrived far from the usual biotech spotlight.…

Oncology Is Turning Maintenance Therapy Into Strategy
Testing

Oncology Is Turning Maintenance Therapy Into Strategy

Marcus ChenJune 25, 2026June 25, 2026

Drug development stories are often told through breakthroughs at the moment of diagnosis: a new target, a sharper biomarker, a…

The Next Frontier of Healthcare: Why Confidential Computing is the Missing Link in AI-Driven Biotech
Opinion

The Next Frontier of Healthcare: Why Confidential Computing is the Missing Link in AI-Driven Biotech

Lisa LoudJune 24, 2026

We stand at the precipice of a medical revolution. Artificial intelligence is no longer a futuristic concept confined to research…

Clinical-Trial Speed Is Becoming a National Biotech Asset
Healthcare

Clinical-Trial Speed Is Becoming a National Biotech Asset

Jane AubreyJune 24, 2026June 24, 2026

Biotech policy has spent the last several years talking as if national competitiveness were mainly a question of patents, subsidies,…

Gene Therapy Is Entering Its Durability Audit Era
Genetics

Gene Therapy Is Entering Its Durability Audit Era

Jane AubreyJune 23, 2026June 23, 2026

The latest update from Taysha Gene Therapies is easy to misread as a conventional rare-disease data release. The company announced…

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