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U.S. Food and Drug Administration

Pharma & Biotech

Preservative-free ketamine gets FDA approval as NRx Pharmaceuticals targets US hospital supply

NRx Pharmaceuticals secures FDA approval for preservative-free ketamine. Discover what it means for drug shortages and domestic manufacturing.

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Features & Analysis

Sabirnetug trial failure forces Acumen Pharmaceuticals to reassess Alzheimer’s drug development strategy

Acumen Pharmaceuticals halts sabirnetug after its Phase 2 Alzheimer's trial fails despite amyloid reduction. Discover what the findings mean.

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Pharma & Biotech

Afimetoran Phase 2 trial delivers significant lupus improvement as Beeline Medicines eyes pivotal studies

Explore Beeline Medicines' Phase 2 afimetoran lupus results, showing a 30-point response advantage and promising potential for an oral therapy.

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Pharma & Biotech

Tafenoquine combinations show promising parasite clearance in immunocompromised patients with babesiosis

60 Degrees Pharmaceuticals reports negative Babesia PCR tests in five patients receiving tafenoquine combinations, with FDA discussions planned.

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Pharma & Biotech

Could ATI-052 offer a new approach to asthma and eczema? Phase 1b findings support further testing

Aclaris Therapeutics' ATI-052 shows promising Phase 1b asthma and eczema results. Explore the clinical findings and upcoming Phase 2b plans.

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Pharma & Biotech

Vopimetostat and daraxonrasib show strong tumor responses as Tango Therapeutics targets Phase 3

Tango Therapeutics reports 82% response with vopimetostat and daraxonrasib in pancreatic cancer. Explore the trial results and Phase 3 plans.

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Pharma & Biotech

Rina-S Phase 3 success brings new hope for platinum-resistant ovarian cancer patients

Genmab's Rina-S cuts the death hazard by 57% in a Phase 3 ovarian cancer trial. Explore the survival results, treatment potential and FDA outlook.

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Pharma & Biotech

Olorofim Phase 3 results show fewer kidney complications in patients with invasive aspergillosis

F2G and Shionogi's oral olorofim meets Phase 3 aspergillosis endpoint with fewer kidney adverse events. Explore the results and FDA plans.

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Pharma & Biotech

Roivant and Priovant report 62% steroid-free disease control with brepocitinib in uveitis trials

Roivant's brepocitinib succeeds in two Phase 3 uveitis trials, improving steroid-free disease control. Explore the results and FDA plans.

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Pharma & Biotech

OD-001 ulcerative colitis study shows clinical response in 61% of higher-dose patients

Odyssey Therapeutics reports 27% remission with OD-001 in Phase 2a ulcerative colitis testing. Explore the findings and next clinical trials.

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