North America

The United States and Canada.
Regulatory Science

Aclaris Therapeutics wins Fast Track tag for modzatinib in lichen planus

The FDA granted Fast Track Designation to modzatinib for moderate to severe lichen planus, a condition with no currently approved therapies.
The FDA granted Fast Track Designation to modzatinib for moderate to severe lichen planus, a condition with no currently approved therapies.
Biologics
Regulatory Science

Artiva Biotherapeutics initiates Phase 3 RA trial after RMAT designation

Artiva's AlloNK NK cell therapy secured FDA RMAT designation for refractory RA as it launches a 150-patient Phase 3 trial backed by $349m
Artiva's AlloNK NK cell therapy secured FDA RMAT designation for refractory RA as it launches a 150-patient Phase 3 trial backed by $349m
Biologics

Ascendis reports durable growth data from COACH and ApproaCH trials

Ascendis Pharma's combination therapy hit the 97th percentile for growth velocity at Week 78, while YUVIWEL surpassed 170 patient enrolments in the U.S.
Ascendis Pharma's combination therapy hit the 97th percentile for growth velocity at Week 78, while YUVIWEL surpassed 170 patient enrolments in the U.S.
Biologics
Regulatory Science

Pharvaris AAE-C1INH burden study published in Frontiers Immunology

Pharvaris published the first qualitative disease-burden study in AAE-C1INH, informing endpoint selection for its ongoing Phase 3 CREAATE trial of deucrictibant.
Pharvaris published the first qualitative disease-burden study in AAE-C1INH, informing endpoint selection for its ongoing Phase 3 CREAATE trial of deucrictibant.
Biologics

Cellectis lasme-cel wins FDA RMAT tag ahead of Phase 2 interim read

Cellectis secured RMAT designation for its allogeneic CAR-T candidate lasme-cel and holds $169m in cash into Q4 2027.
Cellectis secured RMAT designation for its allogeneic CAR-T candidate lasme-cel and holds $169m in cash into Q4 2027.
Biologics

IN8bio GBM data shows mOS above 19.5 months in repeat-dose patients

IN8bio reported updated Phase 1 glioblastoma data and advanced its CD19-targeting gamma-delta T cell engager toward IND-enabling studies.
IN8bio reported updated Phase 1 glioblastoma data and advanced its CD19-targeting gamma-delta T cell engager toward IND-enabling studies.
Digital Health

iRhythm to acquire VitalConnect for $287.5m in cash and stock

The Nasdaq-listed cardiac monitoring company will pay $237.5m in cash and $50m in stock for the wearable biosensor firm.
The Nasdaq-listed cardiac monitoring company will pay $237.5m in cash and $50m in stock for the wearable biosensor firm.
Regulatory Science

Priovant enrolls first patients in Phase 3 brepocitinib CS trial

Priovant's BEACON+ study targets a rare inflammatory skin disease with no approved therapies, with topline data expected in 2028.
Priovant's BEACON+ study targets a rare inflammatory skin disease with no approved therapies, with topline data expected in 2028.
Diagnostics

Tarsus Pharmaceuticals raises XDEMVY guidance after 69% sales surge

The Irvine-based eye care company reported record Q2 sales of $173.9m for XDEMVY and announced a deal to acquire Alkeus Pharmaceuticals for its
The Irvine-based eye care company reported record Q2 sales of $173.9m for XDEMVY and announced a deal to acquire Alkeus Pharmaceuticals for its
Diagnostics
Digital Health

Sigrid Therapeutics lists SiPore® portfolio on Fullscript platform

Stockholm-based Sigrid Therapeutics has made its gut-local metabolic health products available to over 125,000 US practitioners via Fullscript.
Stockholm-based Sigrid Therapeutics has made its gut-local metabolic health products available to over 125,000 US practitioners via Fullscript.
Diagnostics
Digital Health
Biotech

Sigrid Therapeutics lists SiPore® range on Fullscript platform

The Stockholm-based company's gut-local metabolic health products are now accessible to more than 125,000 US practitioners via Fullscript.
The Stockholm-based company's gut-local metabolic health products are now accessible to more than 125,000 US practitioners via Fullscript.
Biologics

Arcutis raises 2026 guidance after ZORYVE revenue jumps 59%

Arcutis posted Q2 net product revenue of $129.9m, up 59% year-on-year, and lifted its full-year sales guidance to $525m–$540m.
Arcutis posted Q2 net product revenue of $129.9m, up 59% year-on-year, and lifted its full-year sales guidance to $525m–$540m.
Diagnostics

Biodesix posts 34% revenue growth in Q2 2026 on lung test volumes

The Colorado-based lung diagnostics company reported $26.9m in Q2 revenue and maintained full-year guidance of $108–114m.
The Colorado-based lung diagnostics company reported $26.9m in Q2 revenue and maintained full-year guidance of $108–114m.
Diagnostics

Black Diamond reports 86% CNS response rate for silevertinib in NSCLC

Phase 2 data show silevertinib achieved a 60% ORR and 86% CNS response in frontline non-classical EGFRm NSCLC, with no de novo brain metastases
Phase 2 data show silevertinib achieved a 60% ORR and 86% CNS response in frontline non-classical EGFRm NSCLC, with no de novo brain metastases
Biologics

BriaCell wins FDA clearance for Bria-PROS+ prostate cancer study

BriaCell's next-generation personalised cell-based immunotherapy for prostate cancer can now enter a Phase 1/2a trial after receiving FDA IND clearance.
BriaCell's next-generation personalised cell-based immunotherapy for prostate cancer can now enter a Phase 1/2a trial after receiving FDA IND clearance.
Biotech

Eos Energy posts 351% revenue jump but narrows 2026 guidance

The zinc-based storage company grew Q2 revenue to $68.8m but tightened its full-year outlook to $300m–$350m as manufacturing consolidation weighs on
The zinc-based storage company grew Q2 revenue to $68.8m but tightened its full-year outlook to $300m–$350m as manufacturing consolidation weighs on
Diagnostics

Eton Pharmaceuticals licenses ASN-001 to broaden hemangioma portfolio

Eton has acquired US rights to topical timolol gel ASN-001, targeting moderate infantile hemangiomas with an NDA filing planned for late 2027.
Eton has acquired US rights to topical timolol gel ASN-001, targeting moderate infantile hemangiomas with an NDA filing planned for late 2027.
Biologics
Regulatory Science

IQVIA and Medera partner to advance cardiac gene therapy trials

IQVIA will provide clinical and regulatory infrastructure to Medera's AAV gene therapy and human cardiac tissue modelling platforms.
IQVIA will provide clinical and regulatory infrastructure to Medera's AAV gene therapy and human cardiac tissue modelling platforms.
Biologics

Nurix earns $10m milestone as Sanofi starts STAT6 degrader Phase 1

Sanofi's first-in-human trial of oral STAT6 degrader SAR448272 triggers a milestone payment, bringing Nurix's total collaboration receipts to roughly $139m.
Sanofi's first-in-human trial of oral STAT6 degrader SAR448272 triggers a milestone payment, bringing Nurix's total collaboration receipts to roughly $139m.
Biologics

NeuroThera Labs opens Yale site for Phase IIb Tourette trial

SCI-110, a cannabinoid combination candidate, is now being tested across three global sites after Phase IIa data showed a 21% average tic reduction.
SCI-110, a cannabinoid combination candidate, is now being tested across three global sites after Phase IIa data showed a 21% average tic reduction.
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