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United States Food and Drug Administration

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Representative image: An ophthalmology team reviews retinal scans as Ocugen’s $OCGN OCU410 one-time gene therapy receives FDA RMAT designation ahead of a Phase 3 geographic atrophy trial.
Pharma & Biotech

FDA grants RMAT designation to OCU410 after Phase 2 geographic atrophy results

OCU410 receives FDA RMAT designation after Phase 2 data showed 31% slower geographic atrophy lesion growth with one gene therapy dose.

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Verastem Oncology has dosed the first patient in the TARGET-D 203 Phase 2 trial evaluating VS-7375 for KRAS G12D-mutated metastatic colorectal cancer, advancing its registration-directed precision oncology programme. Representative image.
Pharma & Biotech

Verastem has opened its KRAS G12D colorectal cancer trial, but the real test is still ahead

Verastem has started TARGET-D 203, testing VS-7375 alone and in combinations for KRAS G12D metastatic colorectal cancer.

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Representative image: Clinicians review muscle imaging and RNA research data as Dyne Therapeutics’ $DYN DYNE-302 receives FDA clearance to enter its first human trial in facioscapulohumeral muscular dystrophy.
Pharma & Biotech

FDA clears DYNE-302 Phase 1 trial targeting DUX4 in facioscapulohumeral muscular dystrophy

FDA clears Dyne’s Phase 1 DYNE-302 trial in FSHD, testing safety, DUX4 suppression and muscle-targeted siRNA delivery.

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Representative image: A researcher reviews alcohol use disorder trial data as Altimmune’s $ALT pemvidutide reduces heavy drinking days and improves lower-risk drinking outcomes in the Phase 2 RECLAIM study.
Pharma & Biotech

Pemvidutide cuts heavy drinking days in Phase 2 alcohol use disorder trial

Pemvidutide reduced heavy drinking days in Altimmune’s Phase 2 RECLAIM trial, but gastrointestinal side effects and limited patient diversity remain.

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Epitel’s $26 million Series B aims to accelerate the United States expansion of its REMI wireless EEG monitoring platform for longer-duration seizure detection and remote neurological care. Representative image.
Medical Devices & Diagnostics

Epitel’s $26m bet could take weeks-long wireless EEG monitoring beyond specialist centres

Epitel’s $26 million Series B will expand REMI wireless EEG monitoring, provider adoption and ambulatory seizure detection across the United States.

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Galmed Pharmaceuticals is developing an oral dispersible film formulation of Aramchol for Parkinson’s disease, aiming to combine brain penetration with easier long-term dosing, although clinical efficacy in patients remains unproven. Representative image.
Pharma & Biotech

Can Galmed’s dissolving Aramchol film turn a former liver drug into a Parkinson’s contender?

Galmed’s Aramchol film may simplify Parkinson’s dosing, but clinical proof and regulatory clearance remain ahead. See what matters next.

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CSL’s positive Phase 3b ANDEMBRY results support planned regulatory filings for garadacimab-gxii in children aged 2 to 11 with hereditary angioedema. Representative image.
Pharma & Biotech

CSL plans expanded pediatric ANDEMBRY filing after positive garadacimab Phase 3b data

CSL’s pediatric ANDEMBRY data support filings in children aged 2 to 11, but regulators still need full safety, PK and efficacy results.

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DifGen Pharmaceuticals’ investigational DFGN-101 programme is advancing toward clinical testing as a potential single-injection treatment approach for women with advanced or metastatic breast cancer. Representative image.
Pharma & Biotech

Can one injection replace two? DifGen’s DFGN-101 enters clinical development through a streamlined FDA pathway

DifGen’s DFGN-101 can enter clinical testing after FDA IND clearance, advancing a single-injection approach for advanced breast cancer.

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A clinician reviews a lung scan as bioAffinity Technologies advances the CyPath Lung clinical framework for pulmonary nodule risk stratification and early lung cancer detection. Representative image.
Medical Devices & Diagnostics

How could CyPath Lung fit into pulmonary nodule evaluation after low-dose CT screening?

bioAffinity’s CyPath Lung framework targets pulmonary nodule decisions, but adoption still depends on prospective validation and payer support.

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Neuvotion targets stroke and spinal cord injury rehabilitation with NeuStim commercial launch
Medical Devices & Diagnostics

Neuvotion NeuStim commercialization advances as brain-computer interface research gains validation

Neuvotion links its fall NeuStim launch to a Nature Medicine brain-body interface study, while the implanted system remains investigational.

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