North America

The United States and Canada.
Cell & Gene Therapy
Biologics

CIRM awards $9m to Enloe Health for Northern California CGT centre

The California Institute for Regenerative Medicine is funding a new Community Care Centre of Excellence in Chico, extending CAR-T access to underserved Northern
The California Institute for Regenerative Medicine is funding a new Community Care Centre of Excellence in Chico, extending CAR-T access to underserved Northern
Synthetic Biology
Bioprocessing

Kraig Biocraft completes Atlas Gene Library in silkworm hosts

Kraig Biocraft says finishing its Atlas Gene Library unlocks over 200 genetic configurations in its pursuit of advanced spider silk fibres.
Kraig Biocraft says finishing its Atlas Gene Library unlocks over 200 genetic configurations in its pursuit of advanced spider silk fibres.
Biologics
Pharmaceuticals

Medicenna to present bizaxofusp rGBM survival data at SNO 2026

Medicenna's IL-4-targeted glioblastoma candidate will receive an oral slot at the Society for Neuro-Oncology meeting in November.
Medicenna's IL-4-targeted glioblastoma candidate will receive an oral slot at the Society for Neuro-Oncology meeting in November.
Pharmaceuticals
Diagnostics

Milestone Pharma enrols first Canadian patient in AFib-RVR trial

Milestone Pharmaceuticals has activated the Montreal Heart Institute as its first Canadian site for the ReVeRA-301 Phase 3 study of etripamil nasal spray in
Milestone Pharmaceuticals has activated the Montreal Heart Institute as its first Canadian site for the ReVeRA-301 Phase 3 study of etripamil nasal spray in
Medical Devices
Digital Health

neurocare and Wave Neuroscience partner on EEG-guided PTSD therapy

The collaboration brings Wave Neuroscience's FDA-cleared MeRT system onto neurocare's Apollo TMS platform, targeting the 16 million Americans affected by PTSD.
The collaboration brings Wave Neuroscience's FDA-cleared MeRT system onto neurocare's Apollo TMS platform, targeting the 16 million Americans affected by PTSD.
Pharmaceuticals
Regulatory Science

Newron's ENIGMA-TRS 2 US enrolment hold stays as ex-US sites expand

The FDA has confirmed its US clinical hold on evenamide's ENIGMA-TRS 2 trial; Newron is expanding enrolment across Europe, Asia and Latin America.
The FDA has confirmed its US clinical hold on evenamide's ENIGMA-TRS 2 trial; Newron is expanding enrolment across Europe, Asia and Latin America.
Pharmaceuticals
Biologics

PridCor Therapeutics advances Phase 2 SHIELD Long COVID study

The Alabama biotech has made its first payment to Mount Sinai under a clinical agreement, with enrollment in the 150-patient SHIELD trial expected shortly.
The Alabama biotech has made its first payment to Mount Sinai under a clinical agreement, with enrollment in the 150-patient SHIELD trial expected shortly.
Pharmaceuticals

Vistagen sees fasedienol signal in severe social anxiety

Exploratory subgroup analyses from two trials showed fasedienol reduced anxiety symptoms in participants with very severe social anxiety disorder.
Exploratory subgroup analyses from two trials showed fasedienol reduced anxiety symptoms in participants with very severe social anxiety disorder.
Pharmaceuticals
Biologics

ADARx Pharmaceuticals prices $446m IPO on Nasdaq

The San Diego siRNA biotech raised up to $535m including an AbbVie cornerstone placement, valuing one of 2026's larger biotech listings.
The San Diego siRNA biotech raised up to $535m including an AbbVie cornerstone placement, valuing one of 2026's larger biotech listings.
Pharmaceuticals
Biologics

Avacta presents FOCUS-01 trial design and AVA6103 PDAC data at AACR

Avacta Therapeutics shared preclinical PDX data and Phase 1 trial design for its FAP-targeted peptide-drug conjugate AVA6103 at the AACR pancreatic cancer conference.
Avacta Therapeutics shared preclinical PDX data and Phase 1 trial design for its FAP-targeted peptide-drug conjugate AVA6103 at the AACR pancreatic cancer conference.
Medical Devices
Digital Health
Diagnostics

Firefly and NeuroSigma partner to distribute FDA-cleared ADHD device

Firefly Neuroscience will introduce NeuroSigma's Monarch eTNS sleep-worn neurostimulator to its US clinician network as a non-drug ADHD option for children.
Firefly Neuroscience will introduce NeuroSigma's Monarch eTNS sleep-worn neurostimulator to its US clinician network as a non-drug ADHD option for children.
Digital Health

Knowtex named prime awardee on VA's $775m ambient scribe contract

The San Francisco AI healthcare company is one of only two prime awardees on the VA's five-year enterprise ambient scribe contract worth up
The San Francisco AI healthcare company is one of only two prime awardees on the VA's five-year enterprise ambient scribe contract worth up
Proteomics
Diagnostics
Biologics

Alamar Biosciences platform underpins Lancet Neurology lecanemab study

A Washington University cohort study used Alamar's 130-protein plasma panel to show amyloid clearance and cognitive response reflect distinct biological processes.
A Washington University cohort study used Alamar's 130-protein plasma panel to show amyloid clearance and cognitive response reflect distinct biological processes.
Cell & Gene Therapy
Biologics

CARVYKTI: half of earlier-line myeloma patients free at five years

Five-year CARTITUDE-2 data show 50% of RRMM patients remained alive and progression-free after a single cilta-cel infusion, with overall survival at
Five-year CARTITUDE-2 data show 50% of RRMM patients remained alive and progression-free after a single cilta-cel infusion, with overall survival at
Pharmaceuticals
Diagnostics

Nanobiotix reports NBTXR3 NSCLC data and €86m raise

Nanobiotix posted H1 2026 results showing encouraging NBTXR3 response rates in lung and head and neck cancer trials, backed by a freshly raised €86 million.
Nanobiotix posted H1 2026 results showing encouraging NBTXR3 response rates in lung and head and neck cancer trials, backed by a freshly raised €86 million.
Pharmaceuticals
Biologics

Pharming wins FDA Priority Review for Joenja in lighter children

Pharming's sNDA for lower leniolisib doses in children weighing 13-27 kg with APDS has a PDUFA date of 30 January 2027.
Pharming's sNDA for lower leniolisib doses in children weighing 13-27 kg with APDS has a PDUFA date of 30 January 2027.
Biologics
Pharmaceuticals
Regulatory Science

aTyr Pharma secures FDA alignment on efzofitimod Phase 3 design

aTyr Pharma has agreed a Phase 3 protocol with the FDA for efzofitimod in pulmonary sarcoidosis, with study activities due to begin in Q4 2026.
aTyr Pharma has agreed a Phase 3 protocol with the FDA for efzofitimod in pulmonary sarcoidosis, with study activities due to begin in Q4 2026.
Pharmaceuticals
Biologics

Elicio Therapeutics AMPLIFY-7P data selected for ESMO 2026 oral slot

Phase 2 KRAS-targeting immunotherapy data will be presented at ESMO Congress in Madrid on 23 October, informing a refined Phase 3 strategy.
Phase 2 KRAS-targeting immunotherapy data will be presented at ESMO Congress in Madrid on 23 October, informing a refined Phase 3 strategy.
Biologics
Pharmaceuticals

IMUNON reports 14.7-month OS gain from Phase 2 ovarian cancer trial

IMUNON's IMNN-001 showed a 14.7-month median overall survival advantage over standard care in a 112-patient Phase 2 study, as its
IMUNON's IMNN-001 showed a 14.7-month median overall survival advantage over standard care in a 112-patient Phase 2 study, as its
Cell & Gene Therapy
Pharmaceuticals

Ligand commits up to $47m to back AvenCell's allogeneic CAR-T pipeline

Ligand Pharmaceuticals will fund AvenCell Therapeutics in tranches tied to clinical milestones, taking a royalty on all current and future pipeline assets.
Ligand Pharmaceuticals will fund AvenCell Therapeutics in tranches tied to clinical milestones, taking a royalty on all current and future pipeline assets.
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