Regulation

Genomics
Diagnostics
Regulatory Science

NAD recommends Nucleus Genomics modify embryo screening ad claims

The US ad watchdog ruled that Nucleus IVF+ marketing overstated accuracy for disease risk, height, IQ and eye colour; Nucleus will appeal.
The US ad watchdog ruled that Nucleus IVF+ marketing overstated accuracy for disease risk, height, IQ and eye colour; Nucleus will appeal.
Pharmaceuticals
Regulatory Science

Nicox NCX 470 NDA accepted for review by China's NMPA

China's NMPA has accepted the NCX 470 glaucoma NDA filed by Nicox's licensee Ocumension, with a regulatory decision expected within 12 to 18
China's NMPA has accepted the NCX 470 glaucoma NDA filed by Nicox's licensee Ocumension, with a regulatory decision expected within 12 to 18
AgriTech
Diagnostics

Rad Source launches Sterile Insect Farms division for mosquito control

Rad Source Technologies is commercialising X-ray-sterilised male mosquitoes for public health districts seeking a non-chemical population control method.
Rad Source Technologies is commercialising X-ray-sterilised male mosquitoes for public health districts seeking a non-chemical population control method.
Cell & Gene Therapy
Biologics
Regulatory Science

Resolution Therapeutics completes enrolment in EMERALD liver trial

All 15 patients have been dosed with RTX001 in the Phase I/II EMERALD trial; interim data are expected in Q4 2026.
All 15 patients have been dosed with RTX001 in the Phase I/II EMERALD trial; interim data are expected in Q4 2026.
Medical Devices

Health Textiles Nigeria begins PermaNet Dual net production

Vestergaard's new Lagos facility is Nigeria's first to manufacture dual-active ingredient insecticide-treated nets, targeting 10 million units a year.
Vestergaard's new Lagos facility is Nigeria's first to manufacture dual-active ingredient insecticide-treated nets, targeting 10 million units a year.
Pharmaceuticals
Regulatory Science

Adneuris presents Phase 3 and abuse-potential data for cebranopadol

Pivotal ALLEVIATE studies met primary endpoints for acute pain, and new data suggest cebranopadol carries lower abuse potential than oxycodone.
Pivotal ALLEVIATE studies met primary endpoints for acute pain, and new data suggest cebranopadol carries lower abuse potential than oxycodone.
Medical Devices

Axogen to acquire BioCircuit Technologies for $200m cash

Axogen is buying the maker of NerveTape, the first FDA-approved sutureless peripheral nerve repair device, in a deal expected to close in Q4 2026.
Axogen is buying the maker of NerveTape, the first FDA-approved sutureless peripheral nerve repair device, in a deal expected to close in Q4 2026.
Pharmaceuticals
Diagnostics

CervoMed neflamapimod nfvPPA biomarker data accepted at ISFTD 2026

CervoMed will present 12-week plasma biomarker data from its Phase 2a nfvPPA trial at ISFTD in October, covering at least 22 participants.
CervoMed will present 12-week plasma biomarker data from its Phase 2a nfvPPA trial at ISFTD in October, covering at least 22 participants.
Cell & Gene Therapy
Biologics
Pharmaceuticals

Legend Biotech to present five-year CARVYKTI data at IMS 2026

Legend Biotech will show long-term CARTITUDE-2 and real-world cilta-cel data at the International Myeloma Society meeting in Glasgow this month.
Legend Biotech will show long-term CARTITUDE-2 and real-world cilta-cel data at the International Myeloma Society meeting in Glasgow this month.
Pharmaceuticals
Diagnostics

Medicus Pharma selects 200 µg SkinJect dose after Phase 2 BCC readout

Medicus Pharma published its Phase 2 CSR for SkinJect, selecting the 200 µg patch dose and pivoting development toward rare Gorlin syndrome.
Medicus Pharma published its Phase 2 CSR for SkinJect, selecting the 200 µg patch dose and pivoting development toward rare Gorlin syndrome.
Medical Devices
Digital Health

ONWARD Medical doubles revenue as ARC-EX unit sales surge 430%

The Eindhoven neurotechnology company reported EUR 4.2M in H1 2026 revenue and enrolled 22 participants in its pivotal ARC-IM blood pressure study.
The Eindhoven neurotechnology company reported EUR 4.2M in H1 2026 revenue and enrolled 22 participants in its pivotal ARC-IM blood pressure study.
Pharmaceuticals
Bioprocessing

Optimi Health to launch Phase 2 psilocybin trial for depression

The Vancouver-based manufacturer will run a 200-participant, Health Canada-authorised study of naturally derived psilocybin in major depressive disorder.
The Vancouver-based manufacturer will run a 200-participant, Health Canada-authorised study of naturally derived psilocybin in major depressive disorder.
Pharmaceuticals
Biologics

Beeline Medicines' afimetoran meets Phase 2 primary endpoint in SLE

The Stamford biotech reported highly significant SRI-4 response rates versus placebo at Week 48, supporting pivotal development in systemic and cutaneous lupus.
The Stamford biotech reported highly significant SRI-4 response rates versus placebo at Week 48, supporting pivotal development in systemic and cutaneous lupus.
Pharmaceuticals
Biologics

Ascendis Pharma reports 52-week infant data for TransCon CNP at ESPE

Week 52 sentinel cohort data show navepegritide stabilised foramen magnum stenosis and improved linear growth in infants with achondroplasia.
Week 52 sentinel cohort data show navepegritide stabilised foramen magnum stenosis and improved linear growth in infants with achondroplasia.
Biologics
Medical Devices
Regulatory Science

Humacyte wins FDA nod to extend Symvess shelf life to 36 months

The FDA has authorised doubling Symvess's expiry dating, easing hospital inventory management for the bioengineered vascular conduit approved in 2024.
The FDA has authorised doubling Symvess's expiry dating, easing hospital inventory management for the bioengineered vascular conduit approved in 2024.
Pharmaceuticals
Diagnostics

ImPact Biotech completes ENLIGHTED Phase 3 for padeliporfin VTP

ImPact Biotech has treated all 91 patients in its Phase 3 LG-UTUC trial and expects to file an NDA with the FDA in 2027.
ImPact Biotech has treated all 91 patients in its Phase 3 LG-UTUC trial and expects to file an NDA with the FDA in 2027.
Cell & Gene Therapy
Genomics
Pharmaceuticals

Opus Genetics reports positive Phase 1/2 OPGx-BEST1 data

All five Cohort 1 participants showed clinically meaningful visual improvement, and the FDA has aligned on a potential pivotal endpoint for the rare retinal disease
All five Cohort 1 participants showed clinically meaningful visual improvement, and the FDA has aligned on a potential pivotal endpoint for the rare retinal disease
Pharmaceuticals
Regulatory Science

BridgeBio PROPEL 3 data show infigratinib cuts ear infections

Exploratory analyses from the Phase 3 PROPEL 3 trial show oral infigratinib reduced otitis media rates by 38% and stabilised sleep apnea measures versus placebo.
Exploratory analyses from the Phase 3 PROPEL 3 trial show oral infigratinib reduced otitis media rates by 38% and stabilised sleep apnea measures versus placebo.
Pharmaceuticals
Biologics

Sobi wins FDA Fast Track for pacritinib in VEXAS syndrome

The designation accelerates review of the dual IRAK1/JAK2 inhibitor in a rare autoinflammatory disease with no approved treatments; topline Phase 2 data expected in
The designation accelerates review of the dual IRAK1/JAK2 inhibitor in a rare autoinflammatory disease with no approved treatments; topline Phase 2 data expected in
Biologics
Pharmaceuticals

SOTIO doses first patient in CDH17-targeting ADC trial for CRC

SOTIO Biotech has initiated its CADENCIA-01 Phase 1/2 trial of SOT109, the only CDH17-targeting ADC with FDA Fast Track Designation, in advanced
SOTIO Biotech has initiated its CADENCIA-01 Phase 1/2 trial of SOT109, the only CDH17-targeting ADC with FDA Fast Track Designation, in advanced
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