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Representative image: A generic inhaler device in a clinical research setting, illustrating Transpire Bio’s FDA-accepted ANDA filing for a proposed generic high-strength Trelegy Ellipta alternative for asthma and COPD treatment.
Pharma & Biotech

What Transpire Bio’s Trelegy ANDA reveals about the next wave of inhaler competition

Trelegy is a blockbuster, but complex inhaler generics are closing in. Transpire Bio’s FDA filing could test GSK’s respiratory moat.

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Representative image: Aurie’s FDA De Novo grant for a reusable no-touch intermittent catheter system highlights a potential shift in urology care, as reusable catheter technology challenges the long-standing dominance of single-use urinary catheters in chronic care settings.
Medical Devices & Diagnostics

Did Aurie just crack the one-use catheter problem hospitals avoided for decades?

Single-use catheters finally face a regulated reuse challenge. Aurie’s FDA De Novo win could shift urology device economics.

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Representative image: A cuffless fingertip blood pressure monitoring device shows how Biozen’s FDA-cleared BP1000 could make calibration-free hypertension checks more accessible for home care and remote patient monitoring.
Medical Devices & Diagnostics

Can Biozen turn cuffless blood pressure from medtech promise into clinical reality?

Cuffs are accurate but inconvenient. Biozen’s FDA-cleared BP1000 tests whether fingertip blood pressure checks can change hypertension care.

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Corvention targets balloon aortic valvuloplasty gap with FDA-cleared KardiaPSI device
Medical Devices & Diagnostics

FDA clears Corvention’s KardiaPSI Balloon Catheter as structural heart tools get more specialized

Calcified aortic valves need force and control. Corvention’s KardiaPSI clearance tests whether niche BAV tools can scale clinically.

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Representative image of a clinician reviewing oncology imaging and molecular testing data, reflecting how BIZENGRI’s FDA approval could advance targeted treatment for NRG1 fusion-positive cholangiocarcinoma.
Pharma & Biotech

Why Partner Therapeutics’ BIZENGRI approval matters beyond cholangiocarcinoma

Rare cancer biology is becoming commercially actionable. BIZENGRI’s FDA approval puts NRG1 fusion testing under sharper scrutiny.

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Pharma & Biotech

What Actuate Therapeutics, Inc.’s oral formulation push means for pancreatic cancer drug development economics

Actuate Therapeutics, Inc. is advancing oral elraglusib after FDA IND clearance. Discover what this means for pancreatic cancer economics.

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Medical Devices & Diagnostics

How Envoy Medical, Inc.’s FDA pathway could influence the future of implantable hearing systems

Could fully implanted cochlear implants transform hearing restoration? Explore the regulatory, clinical, and market implications now.

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Representative image: A fully automated laboratory blood-testing workflow highlights how Fujirebio’s CE-marked Lumipulse G pTau 217 Plasma assay could support scalable Alzheimer’s disease diagnostics and expand access to biomarker-based cognitive decline evaluation across Europe.
Medical Devices & Diagnostics

Why Europe’s Alzheimer’s testing pathway could shift after Fujirebio’s latest CE marking

Alzheimer’s testing needs scale, not just science. Fujirebio’s CE-marked pTau 217 assay pushes blood biomarkers closer to routine care.

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Representative image: A modern oncology research and strategy setting illustrates Daiichi Sankyo’s DXd antibody drug conjugate expansion plan, as the Japanese drugmaker targets stronger cancer drug leadership through Enhertu, Datroway and its broader 2030 oncology pipeline.
Pharma & Biotech

Why Daiichi Sankyo’s new five-year plan puts oncology at the centre of its next growth phase

Daiichi Sankyo has ADC momentum, but scaling oncology is harder than launching drugs. Its 2030 plan now tests execution, margins and pipeline depth.

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Representative image of an orthopedic surgical team reviewing ACL reconstruction anatomy and knee imaging, illustrating CoreTissue BioEngineering’s CT-ACL001 tissue-regenerative ligament trial and its potential role in advancing anterior cruciate ligament repair.
Medical Devices & Diagnostics

CoreTissue BioEngineering pushes ACL device strategy beyond early safety testing

ACL surgery needs better graft choices. CoreTissue BioEngineering’s CT-ACL001 now faces the harder randomized test.

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