Regulation

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

Sight Sciences wins FDA 510(k) clearance for OMNI Ultra glaucoma system

The Menlo Park eyecare company cleared its next-generation implant-free MIGS device and is targeting a US commercial launch in Q4 2026.
The Menlo Park eyecare company cleared its next-generation implant-free MIGS device and is targeting a US commercial launch in Q4 2026.
Bioprocessing
Synthetic Biology

Capra Biosciences secures more HHS funding to onshore API output

Total ASPR backing reaches $17m as the Virginia biotech moves seven API targets toward commercial-scale domestic manufacturing.
Total ASPR backing reaches $17m as the Virginia biotech moves seven API targets toward commercial-scale domestic manufacturing.
Biologics

Altimmune begins Phase 3 PERFORMA trial of pemvidutide in MASH

Altimmune has started enrolling patients in its global registrational PERFORMA study, with a 52-week data readout anticipated in 2029.
Altimmune has started enrolling patients in its global registrational PERFORMA study, with a 52-week data readout anticipated in 2029.
Biologics

Novo Nordisk raises 2026 guidance as Wegovy pill tops 5m prescriptions

Novo Nordisk lifted its full-year outlook after adjusted Q2 operating profit rose 11% at CER, driven by accelerating GLP-1 volumes and Wegovy pill
Novo Nordisk lifted its full-year outlook after adjusted Q2 operating profit rose 11% at CER, driven by accelerating GLP-1 volumes and Wegovy pill
Regulatory Science

SI-BONE raises 2026 guidance after 15% revenue growth in Q2

The Santa Clara medtech posted $56m in Q2 revenue and filed a third breakthrough-device application, as adjusted EBITDA rose 178% year-on-year.
The Santa Clara medtech posted $56m in Q2 revenue and filed a third breakthrough-device application, as adjusted EBITDA rose 178% year-on-year.
Biologics
Regulatory Science

Sanofi's MenQuadfi wins EU approval for infants from six weeks

The European Commission has expanded MenQuadfi's indication to cover infants from six weeks, extending protection against four meningococcal serogroups.
The European Commission has expanded MenQuadfi's indication to cover infants from six weeks, extending protection against four meningococcal serogroups.
Diagnostics
Digital Health

Eyonis and Olea Medical partner to expand AI lung cancer screening in US

Median Technologies' Eyonis will distribute its FDA-cleared eyonis LCS tool through Canon Medical subsidiary Olea Medical across the US and Europe.
Median Technologies' Eyonis will distribute its FDA-cleared eyonis LCS tool through Canon Medical subsidiary Olea Medical across the US and Europe.
Biologics

EPO upholds SOT201 patent for SOTIO's PD-1 immunocytokine

SOTIO Biotech's IL-15 immunocytokine patent survived a Sanofi-led appeal, reinforcing IP around a Phase 1 programme showing objective responses in heavily pre
SOTIO Biotech's IL-15 immunocytokine patent survived a Sanofi-led appeal, reinforcing IP around a Phase 1 programme showing objective responses in heavily pre
Genomics

Medicus Pharma wins UAE IND nod for genomics-guided endometriosis trial

Medicus Pharma has received UAE DOH authorisation to begin PRECISION-E2, a Phase 2a genomics-integrated study of Teverelix in 84 women with endometriosis.
Medicus Pharma has received UAE DOH authorisation to begin PRECISION-E2, a Phase 2a genomics-integrated study of Teverelix in 84 women with endometriosis.
Digital Health
Diagnostics

First Choice Healthcare to go public via Westin SPAC at $650m valuation

First Choice Healthcare Solutions will merge with Westin Acquisition Corp to list on Nasdaq as Wellgevity 360, valued at approximately $650 million.
First Choice Healthcare Solutions will merge with Westin Acquisition Corp to list on Nasdaq as Wellgevity 360, valued at approximately $650 million.
Diagnostics

MMI wins FDA clearance to expand REMIND Alzheimer's robot surgery study

MMI's IDE supplement approval lets the REMIND study enrol up to 15 patients, testing robotic microsurgery to restore lymphatic drainage in Alzheimer's disease.
MMI's IDE supplement approval lets the REMIND study enrol up to 15 patients, testing robotic microsurgery to restore lymphatic drainage in Alzheimer's disease.

Integra LifeSciences Q2 revenue steady as SurgiMend relaunch nears

Integra posted $418.8m in Q2 revenue and confirmed production at its Braintree facility, setting up a fourth-quarter SurgiMend relaunch.
Integra posted $418.8m in Q2 revenue and confirmed production at its Braintree facility, setting up a fourth-quarter SurgiMend relaunch.
Diagnostics

CorVascular launches ASUS handheld ultrasound range at SVU 2026

CorVascular has introduced the FDA-cleared ASUS LU800 handheld ultrasound to US vascular specialists at the SVU annual conference in Maryland.
CorVascular has introduced the FDA-cleared ASUS LU800 handheld ultrasound to US vascular specialists at the SVU annual conference in Maryland.
Regulatory Science

UroGen secures US patent protecting ZUSDURI to July 2044

UroGen Pharma has received a USPTO Notice of Allowance covering its RTGel-based mitomycin treatment for recurrent bladder cancer, extending exclusivity to 2044.
UroGen Pharma has received a USPTO Notice of Allowance covering its RTGel-based mitomycin treatment for recurrent bladder cancer, extending exclusivity to 2044.
Biologics
Regulatory Science

Leads Biolabs wins IND approval for Opamtistomig in metastatic CRC

China's NMPA cleared a Phase Ib/II trial of the PD-L1/4-1BB bispecific in MSS colorectal cancer, where checkpoint inhibitors have largely
China's NMPA cleared a Phase Ib/II trial of the PD-L1/4-1BB bispecific in MSS colorectal cancer, where checkpoint inhibitors have largely

Beyond Air raises up to $30.1m to fund LungFit PH II launch

Beyond Air priced an at-the-market private placement to fund the commercial launch of its second-generation nitric oxide delivery system, pending FDA approval.
Beyond Air priced an at-the-market private placement to fund the commercial launch of its second-generation nitric oxide delivery system, pending FDA approval.
Biologics

DBV Technologies raises $50m via ATM programme with RA Capital

The French peanut-allergy biotech sold 3.66 million new ADSs at $13.67 each to RA Capital, diluting existing shareholders by approximately 5.82%.
The French peanut-allergy biotech sold 3.66 million new ADSs at $13.67 each to RA Capital, diluting existing shareholders by approximately 5.82%.
Diagnostics
Genomics

BioNexus advances VitaGuard MRD rollout across Southeast Asia

BioNexus Gene Lab Corp. is targeting 2026 deployment of its VitaGuard liquid-biopsy platform in Malaysia and Singapore after a technical visit to its Chinese
BioNexus Gene Lab Corp. is targeting 2026 deployment of its VitaGuard liquid-biopsy platform in Malaysia and Singapore after a technical visit to its Chinese

SynCardia reveals Emperor TAH architecture at IEEE EMBC 2026

Picard Medical's SynCardia made the first public disclosure of its next-generation electromechanical total artificial heart architecture at IEEE EMBC in Toronto.
Picard Medical's SynCardia made the first public disclosure of its next-generation electromechanical total artificial heart architecture at IEEE EMBC in Toronto.
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