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United States Food and Drug Administration

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Asymchem’s dedicated carbapenem facility completes first United States FDA inspection
Pharma & Biotech

Why Asymchem’s first FDA inspection at Dunhua 2 matters far beyond one carbapenem API

Asymchem’s Dunhua 2 site completes its first FDA inspection, advancing continuous carbapenem API manufacturing and U.S. supply readiness.

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A patient receives an oncology infusion as Estrella Immunopharma advances EB103 into the dose-expansion phase of the STARLIGHT-1 trial following early durable responses in advanced B-cell non-Hodgkin lymphoma. Representative image.
Pharma & Biotech

Estrella’s EB103 kept early lymphoma remissions intact, but one trial detail still needs explaining

Estrella advances EB103 into STARLIGHT-1 expansion as early lymphoma remissions endure, while trial scale, safety and funding remain key tests.

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A dermatologist evaluates atopic dermatitis during a clinical consultation as Organon’s Phase 3 pooled analysis shows early, consistent improvements with VTAMA tapinarof cream across pediatric age groups and adults. Representative image.
Pharma & Biotech

Organon VTAMA analysis shows consistent atopic dermatitis efficacy across children and adults

Organon’s VTAMA Phase 3 analysis shows consistent atopic dermatitis responses across children and adults, strengthening its clinical case.

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Otsuka’s FDA approval of SIMTRIYO, or centanafadine, introduces a first-in-class ADHD treatment for adults and children aged six and older, although DEA scheduling, safety monitoring and payer access will shape its commercial adoption. Representative image.
Pharma & Biotech

Otsuka’s SIMTRIYO has FDA approval, but two hurdles will decide whether it can disrupt ADHD care

Otsuka’s SIMTRIYO wins FDA approval for ADHD, but DEA scheduling, boxed warnings and payer access will shape its commercial uptake.

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Representative image: An adult receives a rapid at-home autoinjector treatment as MannKind Corporation’s $MNKD Furoscix ReadyFlow wins FDA approval for edema linked to heart failure and chronic kidney disease.
Pharma & Biotech

MannKind Corporation wins FDA approval for 10-second Furoscix ReadyFlow furosemide autoinjector

FDA approves MannKind Corporation’s Furoscix ReadyFlow for heart failure and CKD edema. See how the 10-second autoinjector may change care.

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Par Health’s launch of the first generic Janumet XR introduces new U.S. competition for sitagliptin and extended-release metformin tablets used in type 2 diabetes care. Representative image.
Pharma & Biotech

Why Par Health’s first generic Janumet XR launch could trigger a rapid U.S. pricing reset

Par Health launches the first U.S. generic Janumet XR, opening a $270 million diabetes market to new pricing and formulary competition.

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NADclinic and Geneva College of Longevity Science are linking clinician education with longevity and performance medicine as the sector pushes for stronger evidence, regulatory awareness and responsible clinical practice. Representative image.
Pharma & Biotech

Can NADclinic and GCLS turn longevity medicine’s training gap into a clinical standard?

NADclinic and GCLS are linking postgraduate education with longevity practice as evidence, regulation and clinical governance face scrutiny.

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Velmeni’s FDA-cleared V4D 3D software brings artificial intelligence-assisted segmentation, visualization and analysis to dental cone-beam computed tomography workflows. Representative image.
Medical Devices & Diagnostics

Velmeni just cleared a major dental AI hurdle, but can its 3D CBCT platform win over clinicians?

Velmeni’s FDA-cleared V4D 3D brings AI-assisted CBCT analysis into dental workflows, but adoption now depends on integration and clinical trust.

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Laminar Pharma’s LAM561 Phase 2b/3 glioblastoma trial has completed its final patient visit, moving the investigational therapy toward a pivotal overall survival readout expected in 2027. Representative image.
Pharma & Biotech

Laminar Pharma has finished patient follow-up. Now one survival result will decide LAM561’s future

Laminar Pharma completes LAM561 trial follow-up as the glioblastoma study advances toward a pivotal overall survival readout in 2027.

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OneLegacy’s partnership with OrganOx aims to expand access to normothermic liver perfusion technology and help Southern California transplant centres evaluate and preserve more donor livers for transplantation. Representative image.
Features & Analysis

Can OneLegacy’s OrganOx perfusion hub turn more donor livers into viable transplants?

OneLegacy is expanding OrganOx metra liver perfusion access across Southern California, testing whether a shared hub can increase transplant capacity.

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