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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
Drug Pricing Is Becoming Trade Policy
Pharma

Drug Pricing Is Becoming Trade Policy

Jane AubreyJune 22, 2026June 22, 2026

Biotech investors are used to thinking about drug pricing as a domestic argument. The traditional battle lines are familiar: governments…

Biotech Patents Are Becoming Industrial Policy Again
Opinion

Biotech Patents Are Becoming Industrial Policy Again

Jane AubreyJune 21, 2026June 21, 2026

Biotech investors usually discuss competitiveness in terms of research quality, clinical execution, manufacturing depth, or access to capital. Those still…

Regulatory Speed Is Becoming Its Own Biotech Asset Class
Biotechnology

Regulatory Speed Is Becoming Its Own Biotech Asset Class

Marcus ChenJune 20, 2026June 20, 2026

The renewed fight over the FDA’s priority-voucher pathway suggests that review time is turning from an administrative variable into a…

The Obesity Boom Is Becoming a Distribution Crackdown
Lifestyle

The Obesity Boom Is Becoming a Distribution Crackdown

Jane AubreyJune 19, 2026June 19, 2026

The latest FDA warning-letter wave shows that the next fight in GLP-1 medicine is shifting from molecule scarcity to control…

No More Excuses: Colon Cancer Screening Just Got a Lot Easier
Lifestyle

No More Excuses: Colon Cancer Screening Just Got a Lot Easier

Amara DialloJune 18, 2026June 18, 2026

New American Cancer Society guidelines add at-home stool tests and a blood draw to the screening menu — a timely…

Beyond the Scale: What GLP-1 Drugs Are Really Doing to Your Body
Healthcare

Beyond the Scale: What GLP-1 Drugs Are Really Doing to Your Body

Marcus ChenJune 18, 2026June 18, 2026

Ozempic and Wegovy have become household names for weight loss, but a wave of new research reveals they are reshaping…

Oncology’s New Bottleneck Is Becoming Treatment Matching
Biotechnology

Oncology’s New Bottleneck Is Becoming Treatment Matching

Jane AubreyJune 18, 2026June 18, 2026

As therapies become more complex and more expensive, biotech is discovering that the next moat may lie in predicting response…

The Resurgence of Biotech: Why the Science of Tomorrow is the Investment of Today
Opinion

The Resurgence of Biotech: Why the Science of Tomorrow is the Investment of Today

Romeo KuokJune 17, 2026June 17, 2026

As macroeconomic headwinds fade and clinical innovation accelerates, the biotechnology sector is emerging from its prolonged winter to offer generational…

Biotech’s Market Is Open Again, but Only for the Most Credible Stories
Biotechnology

Biotech’s Market Is Open Again, but Only for the Most Credible Stories

Jane AubreyJune 17, 2026June 17, 2026

The current biotech tape is not broadly forgiving. It is rewarding scalable platforms, manufacturing leverage, and differentiated clinical assets while…

The Personalized Vaccine Revolution: mRNA Rewrites the Rules of Cancer Immunotherapy
Biotechnology

The Personalized Vaccine Revolution: mRNA Rewrites the Rules of Cancer Immunotherapy

Jane AubreyJune 16, 2026June 16, 2026

Five-year melanoma data and early breakthroughs in pancreatic and brain cancers signal that individualized mRNA vaccines are maturing from proof…

From Simulation to Clinic: How AI Is Rewriting the Rules of Drug Discovery
AI

From Simulation to Clinic: How AI Is Rewriting the Rules of Drug Discovery

Marcus ChenJune 16, 2026June 17, 2026

A 10,000-fold acceleration in molecular simulation, a hidden cancer-protein pocket missed by leading AI tools, and the first human trials…

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