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U.S. Food and Drug Administration

Pharma & Biotech

Curis expands emavusertib PCNSL response pool as TakeAim CLL enrolment accelerates

Curis reports updated emavusertib responses in PCNSL and faster CLL enrolment, while durability, safety and funding remain critical tests.

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Medical Devices & Diagnostics

CONMED’s AirSeal gains a crucial da Vinci 5 fit, but will hospitals change their robotic workflow?

See how CONMED’s AirSeal expansion to da Vinci 5 hex cannulas could influence robotic surgery workflows, adoption and recurring sales.

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Medical Devices & Diagnostics

Johnson & Johnson has entered soft-tissue robotics, but can Ottava loosen da Vinci’s grip?

Johnson & Johnson can launch its table-integrated Ottava surgical robot in the United States, opening a new competitive front against Intuitive Surgical and Medtronic.

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Pharma & Biotech

Pheast Therapeutics strengthens PHST001 case with peer-reviewed anti-CD24 cancer research

Pheast Therapeutics’ PHST001 gains peer-reviewed CD24 data as Phase 1 combination cohorts advance. See what the evidence means.

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Medical Devices & Diagnostics

i-Lumen Scientific begins U.S. pivotal trial of microcurrent therapy for dry AMD

i-Lumen Scientific, Inc. has randomized the first United States patient in its pivotal i-SIGHT2 study, beginning the domestic phase of a multinational trial evaluating whether low-level electrical stimulation delivered through a closed eyelid can improve visual function in people with intermediate-to-advanced dry age-related macular degeneration. The first U.S. randomization occurred at Texas Retina Associates in

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Pharma & Biotech

Nektar Therapeutics starts Phase 3 ZENITH-AD trials of rezpegaldesleukin for atopic dermatitis

Nektar Therapeutics has initiated the first two studies in a 1,530-patient Phase 3 programme evaluating rezpegaldesleukin in adolescents and adults with moderate-to-severe atopic dermatitis, beginning the pivotal test of whether regulatory T-cell stimulation can compete with established eczema biologics and oral medicines. ZENITH AD-1 and ZENITH AD-2 will each enroll approximately 510 patients who have

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Medical Devices & Diagnostics

Bluejay Diagnostics advances Symphony IL-6 test as SYMON-II enrollment concludes

Bluejay Diagnostics, Inc. has completed enrollment in its 750-patient SYMON-II clinical validation study, moving the investigational Symphony IL-6 test into the data-cleaning, sample-testing and statistical-analysis phase that will determine whether the company has a credible basis for a U.S. regulatory submission. The Nasdaq-listed diagnostics developer said enrollment finished earlier than originally anticipated across participating healthcare

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Pharma & Biotech

Agios Pharmaceuticals stops tebapivat sickle cell development after mixed Phase 2 results

Agios Pharmaceuticals, Inc. has decided not to advance tebapivat in sickle cell disease after a randomized Phase 2 trial involving 59 participants failed to establish the differentiated clinical profile required for further investment. The Nasdaq-listed rare-disease drug developer said the once-daily pyruvate kinase activator improved haemoglobin and markers of haemolysis, but the response pattern did

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Pharma & Biotech

PolyPid signs Azurity partnership for D-PLEX100 commercialization in the U.S. and Canada

PolyPid’s Azurity partnership gives D-PLEX100 a U.S. and Canada launch path after Phase 3 SHIELD II surgical site infection data

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Medical Devices & Diagnostics

How QIAGEN’s FDA-cleared QIAstat-Dx test supports the Cyclospora outbreak response

QIAGEN highlights its FDA-cleared QIAstat-Dx panel as U.S. Cyclospora cases rise, while research tools support outbreak tracing.

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