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United States Food and Drug Administration

Pharma & Biotech

Genmab and AbbVie clarify EPCORE DLBCL-1 missed sole US overall survival endpoint

Genmab and AbbVie clarify that EPCORE DLBCL-1 missed its sole US overall survival endpoint despite a PFS benefit for epcoritamab.

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Pharma & Biotech

Summit Therapeutics has $690.7m, but one November FDA decision now towers over everything

Summit Therapeutics ends Q2 with $690.7m as ivonescimab approaches an FDA decision and pivotal HARMONi-3 data in late 2026.

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Pharma & Biotech

Incannex Healthcare begins DReAMzz screening to refine IHL-42X dosing before Phase 3 sleep apnea trial

Incannex Healthcare begins DReAMzz screening to select an IHL-42X dose before Phase 3. Read what the sleep apnea study must prove.

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Pharma & Biotech

Inhibikase Therapeutics gains FDA orphan status for IKT-001 as pivotal PAH trial advances

Inhibikase Therapeutics wins FDA orphan status for IKT-001 as its pivotal PAH trial tests whether a prodrug can improve imatinib tolerability.

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Pharma & Biotech

Verastem has entered the KRAS G12D lung cancer race, but can VS-7375 close the evidence gap?

Verastem begins TARGET-D 202, testing 900 mg VS-7375 in previously treated KRAS G12D NSCLC, including a brain metastases cohort.

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Pharma & Biotech

Affinia Therapeutics advances AFTX-201 gene therapy for BAG3 dilated cardiomyopathy

Affinia Therapeutics gains FDA orphan status for AFTX-201 as the UPBEAT trial tests gene therapy for BAG3 dilated cardiomyopathy.

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Pharma & Biotech

Can TopGum turn brain and eye health into the next major gummy growth category?

TopGum is targeting cognition and eye health with new gummies, but evidence, claim discipline and brand adoption will decide commercial impact.

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Medical Devices & Diagnostics

Could Ultromics EchoGo improve early detection of heart failure with preserved ejection fraction?

Ultromics’ EchoGo model suggests earlier HFpEF detection, but prospective evidence will decide whether hospitals realize the projected gains.

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Pharma & Biotech

D&D Pharmatech’s MASH candidate gains credibility as Phase 2 findings enter peer review

Peer-reviewed Phase 2 data link zabopegdutide to rapid liver fat and stiffness reductions, while Phase 3 validation remains the decisive test.

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Pharma & Biotech

Can Cellares automation move Papillon’s PPL-001 closer to a Friedreich’s ataxia trial?

Cellares will automate PPL-001 manufacturing for Friedreich’s ataxia, but IND-enabling work and human evidence remain ahead.

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