Regulation

Genmab and AbbVie say their EPCORE DLBCL-2 trial is the first Phase 3 bispecific study to hit a PFS endpoint in frontline diffuse large

NorthStrive Biosciences has signed a statement of work with Charles River Laboratories to characterise plasmid copy numbers in its EL-22 and EL-32 engineered

Autonomix Medical says FDA pre-submission feedback supports a Class II substantial-equivalence route, targeting clearance of its neural sensing platform in roughly 15

Elutia has cleared its final 2026 funding milestone, receiving the full $8m holdback from its BioEnvelope sale with no indemnity claims.

New Category I CPT codes covering Inspire V's single-lead hypoglossal nerve stimulator are set to take effect on 1 January 2028.

Flooding at Integra's Ohio manufacturing site will cost up to $27m in lost revenue across Q3 and Q4, prompting a downgrade to full-year

A Delaware district court found two claims of United Therapeutics' '327 patent valid and infringed, putting YUTREPIA's PH-ILD label at risk.

Nexalin Technology has appointed Inovanexa as exclusive distributor for its ANVISA-approved Sync neurostimulation device across seven Latin American countries.

The FDA has extended its review of denecimig for haemophilia A due to facility remediation issues, with no new decision timeline given.

The Nasdaq-listed ophthalmic biotech has acquired its existing IOL manufacturer from Santen, securing Phase 3 supply and a route to premium lens options.

Phase 2 AMETHYST data show over a quarter of litifilimab-treated patients achieved clear or almost clear skin; Phase 3 results are due in H1

The EMA has begun its centralised review of lorecivivint, a small-molecule CLK/DYRK inhibitor Biosplice positions as a potential first disease-modifying therapy for

IBA will offer ARTMS's solid-target QUANTM Irradiation System to cyclotron customers worldwide, supporting local radiometal production for theranostics.

The PD-L1/4-1BB bispecific antibody has now secured orphan drug designation in Japan, the US, and Europe, as its China NDA enters technical

Cullinan Therapeutics has begun an FDA RTOR submission for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion NSCLC, backed by Phase 3 data.

New data presented at MDS 2026 show ecopipam cut tic severity by 45.6% at 18 months, with no new safety signals in an ongoing

Discovery Vitality has expanded its HealthyWeight programme to include clinician-assessed access to anti-obesity medicines alongside structured lifestyle support.

SYNCHRONIZE-2 showed 13.1% average weight loss versus 3.1% on placebo after 76 weeks, with significant glycaemic improvements published in the NEJM.

The EMA has accepted PolyPid's marketing authorisation application for D-PLEX100, which also faces an FDA PDUFA date of 28 November 2026.

Phase III evERA data published in NEJM show giredestrant plus everolimus nearly halved disease progression risk in ER-positive advanced breast cancer.