North America

The United States and Canada.
Biologics
Regulatory Science

Roivant's brepocitinib wins FDA approval for dermatomyositis

LISRAYA becomes the first targeted therapy approved for dermatomyositis, a rare autoimmune disease with few treatment advances in decades.
LISRAYA becomes the first targeted therapy approved for dermatomyositis, a rare autoimmune disease with few treatment advances in decades.
Diagnostics

Verrica completes COVE-2 enrolment for YCANTH common warts label

Verrica Pharmaceuticals has finished enrolling its first pivotal Phase 3 warts trial, with topline data expected in Q1 2027 and a second trial over 50
Verrica Pharmaceuticals has finished enrolling its first pivotal Phase 3 warts trial, with topline data expected in Q1 2027 and a second trial over 50
Digital Health
Diagnostics

Trimedx adds agentic AI to TMX Protect to cut device cyber remediation

Trimedx says new natural-language AI capabilities in TMX Protect cut medical device cybersecurity remediation time by 75% on average.
Trimedx says new natural-language AI capabilities in TMX Protect cut medical device cybersecurity remediation time by 75% on average.
Digital Health
Biotech

Big Digital Energy signs LOI for 17 MW AI campus in Texas

Big Digital Energy's joint venture has signed a non-binding letter of intent with Tensor IQ to develop a 17 MW AI and HPC
Big Digital Energy's joint venture has signed a non-binding letter of intent with Tensor IQ to develop a 17 MW AI and HPC
Diagnostics

BridgeBio doses first patient in ASCEND-ATTR Phase 3b/4 study

BridgeBio has initiated ASCEND-ATTR, a 150-patient study testing whether long-term acoramidis can reverse cardiac damage in ATTR-CM.
BridgeBio has initiated ASCEND-ATTR, a 150-patient study testing whether long-term acoramidis can reverse cardiac damage in ATTR-CM.
Biologics

SOTIO's SOT106 ADC wins FDA Fast Track for soft tissue sarcoma

SOTIO Biotech's LRRC15-targeting antibody-drug conjugate gained Fast Track Designation, with a first-in-human study expected before year end.
SOTIO Biotech's LRRC15-targeting antibody-drug conjugate gained Fast Track Designation, with a first-in-human study expected before year end.
Diagnostics

Femasys brings FemaSeed portfolio to UNC Health OB/GYN network

Femasys and UNC Health have partnered to offer in-office fertility diagnostics and intratubal insemination across the academic system's statewide OB/GYN locations.
Femasys and UNC Health have partnered to offer in-office fertility diagnostics and intratubal insemination across the academic system's statewide OB/GYN locations.
Biologics

Priovant's brepocitinib hits skin remission targets in Phase 3 DM trial

JAMA Dermatology publishes secondary endpoint data showing rapid, durable skin improvements for brepocitinib versus placebo in dermatomyositis.
JAMA Dermatology publishes secondary endpoint data showing rapid, durable skin improvements for brepocitinib versus placebo in dermatomyositis.
Digital Health
Biologics

Johns Hopkins wins NIH R01 to study GLP-1 long-term value

A five-year NIDDK-funded study will use Truveta's 140-million-patient dataset to assess GLP-1 cost-effectiveness and inform coverage decisions.
A five-year NIDDK-funded study will use Truveta's 140-million-patient dataset to assess GLP-1 cost-effectiveness and inform coverage decisions.
Regulatory Science
Biologics

Mereo BioPharma licenses alvelestat to Sentynl in $475m-plus US deal

Mereo will receive up to $475m and tiered royalties if Sentynl exercises its US commercialisation option for the oral AATD-LD candidate.
Mereo will receive up to $475m and tiered royalties if Sentynl exercises its US commercialisation option for the oral AATD-LD candidate.
Biologics

Mesoblast posts US$120m revenue as RYONCIL ramps

Mesoblast reported sevenfold revenue growth in FY2026, driven by RYONCIL's US commercial launch, while its Phase 3 back pain trial completed patient treatment.
Mesoblast reported sevenfold revenue growth in FY2026, driven by RYONCIL's US commercial launch, while its Phase 3 back pain trial completed patient treatment.
Digital Health
Bioinformatics

Philips wins $33.7m ARPA-H award for AI robotic stroke care

Philips will work with Johns Hopkins and Boston University to develop remote and automated endovascular stroke procedures under the ARPA-H AIR programme.
Philips will work with Johns Hopkins and Boston University to develop remote and automated endovascular stroke procedures under the ARPA-H AIR programme.
Regulatory Science

Trump health deals lack enforcement, raising durability concerns

Voluntary, vaguely documented US health industry agreements on drug prices and nutrition may fade without federal enforcement mechanisms, analysts warn.
Voluntary, vaguely documented US health industry agreements on drug prices and nutrition may fade without federal enforcement mechanisms, analysts warn.
Biologics

Alvotech and Lotus sign $150m biosimilar deal for two biologics

Alvotech and Lotus Pharmaceutical will co-commercialise durvalumab and emicizumab biosimilars across the US and eight Asian markets.
Alvotech and Lotus Pharmaceutical will co-commercialise durvalumab and emicizumab biosimilars across the US and eight Asian markets.
Biologics

Apollo Therapeutics: Phase 1 pan-rhinovirus vaccine data positive

APL-10456 induced broad cross-reactive T cell responses against all three rhinovirus species in a 144-participant Phase 1 trial, with no serious adverse
APL-10456 induced broad cross-reactive T cell responses against all three rhinovirus species in a 144-participant Phase 1 trial, with no serious adverse
Biologics

Ascendis shares two-year YUVIWEL data at ISDS 2026

Ascendis Pharma will present Week 104 ApproaCH Trial data on navepegritide in achondroplasia, with FDA approval secured and an EMA decision due Q4 2026.
Ascendis Pharma will present Week 104 ApproaCH Trial data on navepegritide in achondroplasia, with FDA approval secured and an EMA decision due Q4 2026.

Creative Medical completes ADAPT trial enrolment for Olastrocel

CELZ-201 / Olastrocel has treated all patients across the FDA-cleared ADAPT trial, including the opioid cohort, ahead of RMAT evaluation and Phase 3 planning.
CELZ-201 / Olastrocel has treated all patients across the FDA-cleared ADAPT trial, including the opioid cohort, ahead of RMAT evaluation and Phase 3 planning.
Biologics

Monte Rosa doses first patient in Phase 2 MRT-2359 prostate cancer study

Monte Rosa Therapeutics has initiated MODeFIRe-1, a Phase 2 trial of its GSPT1 degrader MRT-2359 plus apalutamide in AR mutation-positive mCRPC patients.
Monte Rosa Therapeutics has initiated MODeFIRe-1, a Phase 2 trial of its GSPT1 degrader MRT-2359 plus apalutamide in AR mutation-positive mCRPC patients.

Nuwellis signs co-promotion deal with Atrility for AtriAmp device

Nuwellis will co-promote Atrility's FDA-cleared cardiac pacing monitor across 14 US states, with an option to become exclusive national distributor.
Nuwellis will co-promote Atrility's FDA-cleared cardiac pacing monitor across 14 US states, with an option to become exclusive national distributor.
Diagnostics

RenovoRx publishes PK/PD data showing 51% tumour-site drug extraction

Peer-reviewed sub-study data from the Phase III TIGeR-PaC trial supports the TAMP platform's targeted delivery mechanism in locally advanced pancreatic cancer.
Peer-reviewed sub-study data from the Phase III TIGeR-PaC trial supports the TAMP platform's targeted delivery mechanism in locally advanced pancreatic cancer.
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