Regulation

MolDX has issued a proposed LCD that could establish Medicare coverage for optical genome mapping in hematologic malignancy workups.

CAMP4 Therapeutics has secured MHRA authorisation to include UK sites in its global Phase 1/2 study of CMP-002, an ASO targeting SYNGAP1-related

CMS has finalised expanded Medicare coverage for TAVR in asymptomatic aortic stenosis, and Circle CVI says its imaging platform is ready to absorb the expected

The Netherlands-based biotech secured a supplemental approval making leniolisib the first FDA-approved treatment for younger children with the rare immunodeficiency APDS.

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

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

Rad Source Technologies is commercialising X-ray-sterilised male mosquitoes for public health districts seeking a non-chemical population control method.

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

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

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

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.

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

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

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

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

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

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

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

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.