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Representative image of acromegaly drug development as Camurus’ Oclaiz FDA setback puts rare disease manufacturing risk, long-acting injectable therapies, and U.S. regulatory scrutiny under sharper focus.
Pharma & Biotech

Camurus Oclaiz CRL shows how one manufacturing site can stall a differentiated endocrine therapy

Find out how Camurus’ fresh FDA setback for Oclaiz could delay its U.S. acromegaly launch and reshape rare disease manufacturing risk.

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Representative image: Clinicians review lung cancer genomic testing data and blood-based diagnostic results, reflecting Guardant Health’s Guardant360 CDx FDA approval as a companion diagnostic for HERNEXEOS in HER2-mutant advanced non-small cell lung cancer.
Medical Devices & Diagnostics

How Guardant360 CDx approval supports Boehringer Ingelheim’s HERNEXEOS launch strategy

Find out how Guardant360 CDx approval could expand liquid biopsy use in HER2-mutant advanced lung cancer treatment selection.

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Representative image of EEG-guided brain stimulation as Wave Neuroscience’s MeRT FDA clearance puts biomarker-led PTSD treatment, neuromodulation, and precision psychiatry under sharper focus.
Medical Devices & Diagnostics

Wave Neuroscience FDA clearance puts EEG-guided PTSD treatment closer to clinical adoption

Find out how Wave Neuroscience’s MeRT FDA clearance could reshape biomarker-guided PTSD treatment and precision psychiatry.

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Representative image: Clinicians review a chest CT scan as AI-assisted lung nodule risk assessment gains attention through Tanner Health’s Optellum rollout, highlighting the push to improve early lung cancer triage in regional care.
Medical Devices & Diagnostics

Why Optellum’s deployment at Tanner Health could matter for lung cancer risk stratification

Find out how Tanner Health’s Optellum rollout could reshape AI lung nodule triage and early lung cancer detection in regional care.

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Representative image of CT imaging analysis as Subtle Medical’s SubtleHD(CT) FDA clearance puts AI-powered image enhancement, radiology workflows, and scanner efficiency under sharper focus.
Medical Devices & Diagnostics

Subtle Medical wins FDA clearance for CT software as scanner pressure intensifies

Find out how Subtle Medical’s FDA-cleared SubtleHD(CT) could reshape AI-powered CT image enhancement and radiology workflows.

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Representative image: A clinician uses a handheld skin assessment device, reflecting DermaSensor’s CE Mark and the growing role of AI-assisted skin cancer triage in European primary care.
Pharma & Biotech

Could DermaSensor’s NHS study turn AI skin cancer tools into primary care infrastructure?

Find out how DermaSensor’s CE Mark and NHS study could reshape AI-assisted skin cancer assessment across European primary care.

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Representative image of bone health biologics research as GlycoNex’s SPD8 Phase III result puts denosumab biosimilar competition, osteoporosis care, and oncology bone disease treatment under sharper focus.
Pharma & Biotech

GlycoNex targets Prolia and Xgeva space as SPD8 meets Phase III equivalence goal

Find out how GlycoNex’s SPD8 Phase III data could intensify denosumab biosimilar competition in osteoporosis and oncology care.

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FDA clearance for Rubina Lens gives KARL STORZ a sharper open surgery proposition
Medical Devices & Diagnostics

Could KARL STORZ’s Rubina Lens turn open surgery into the next imaging battleground?

Find out how KARL STORZ’s Rubina Lens FDA clearance could expand fluorescence imaging in open surgery and hospital workflows.

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Representative image of Alzheimer’s disease research as Elixiron’s enrupatinib data put neuroinflammation, brain imaging, and oral drug development under sharper clinical focus.
Pharma & Biotech

Elixiron’s oral Alzheimer’s drug data raise a bigger question: can neuroinflammation become the next serious treatment target?

Find out how Elixiron’s enrupatinib Phase 2 data could reshape Alzheimer’s neuroinflammation research and what risks remain.

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Representative image of a sleep medicine setting as Apnimed’s AD109 oral therapy advances debate over obstructive sleep apnea treatment, Phase 3 data, and potential FDA review.
Pharma & Biotech

Apnimed advances oral OSA therapy case as AD109 heads toward FDA decision window

Find out how Apnimed’s AD109 Phase 3 data could reshape oral treatment for obstructive sleep apnea as FDA review approaches.

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