Oncology

Biologics

J&J's teclistamab plus daratumumab gets CHMP backing for myeloma

The EMA advisory committee has recommended expanding teclistamab's label to cover second-line relapsed/refractory myeloma, backed by Phase 3 overall survival data.
The EMA advisory committee has recommended expanding teclistamab's label to cover second-line relapsed/refractory myeloma, backed by Phase 3 overall survival data.
Cell & Gene Therapy

IBA to install Brazil's first proton therapy centre in Rio de Janeiro

IBA has signed a contract with FUSVE to bring proton therapy to Brazil for the first time, with a focus on paediatric cancer care.
IBA has signed a contract with FUSVE to bring proton therapy to Brazil for the first time, with a focus on paediatric cancer care.
Regulatory Science

Elevar Therapeutics doses first patients in FGFR2 Phase 2 expansion

Elevar's ReFocus202 trial opens enrolment in non-CCA solid tumours, testing lirafugratinib across a broad range of FGFR2-altered cancers globally.
Elevar's ReFocus202 trial opens enrolment in non-CCA solid tumours, testing lirafugratinib across a broad range of FGFR2-altered cancers globally.

HUTCHMED fanregratinib hits 42.5% ORR in pivotal ICC Phase II

HUTCHMED's FGFR2-targeted oral candidate met its primary endpoint in pretreated intrahepatic cholangiocarcinoma, supporting a China NMPA priority review NDA.
HUTCHMED's FGFR2-targeted oral candidate met its primary endpoint in pretreated intrahepatic cholangiocarcinoma, supporting a China NMPA priority review NDA.
Pharmaceuticals

Orion Pharma's ODM-212 wins EU Orphan Designation for mesothelioma

The Finnish pharma group's oral pan-TEAD inhibitor now holds Orphan Designation on both sides of the Atlantic as its Phase 2 TEADES trial
The Finnish pharma group's oral pan-TEAD inhibitor now holds Orphan Designation on both sides of the Atlantic as its Phase 2 TEADES trial
Biologics

Silexion secures BfArM approval for SIL204 Phase 2/3 LAPC trial

Germany's BfArM has cleared Silexion's siRNA candidate SIL204 for a Phase 2/3 trial in locally advanced pancreatic cancer, with first dosing expected
Germany's BfArM has cleared Silexion's siRNA candidate SIL204 for a Phase 2/3 trial in locally advanced pancreatic cancer, with first dosing expected
Biologics

Boehringer opens three Phase III trials in lung and NEC cancers

Boehringer Ingelheim has initiated three Phase III trials covering obrixtamig in SCLC and epNEC, and zongertinib in resectable HER2-mutant NSCLC.
Boehringer Ingelheim has initiated three Phase III trials covering obrixtamig in SCLC and epNEC, and zongertinib in resectable HER2-mutant NSCLC.
Diagnostics
Genomics

A3P Biomedical's Stockholm3 outperforms PSA in 12,670-man study

Stockholm3 detected 90% of aggressive prostate cancers versus 52% for standard PSA testing in a large population-based screening trial published in Annals of Internal
Stockholm3 detected 90% of aggressive prostate cancers versus 52% for standard PSA testing in a large population-based screening trial published in Annals of Internal
Biologics

Medicenna secures new U.S. patents across IL-2, IL-4 and IL-13 platforms

Medicenna Therapeutics has added two issued U.S. patents and one allowed application, reinforcing IP protection around bizaxofusp and its broader Superkine pipeline.
Medicenna Therapeutics has added two issued U.S. patents and one allowed application, reinforcing IP protection around bizaxofusp and its broader Superkine pipeline.
Biologics

MAIA Biotechnology opens third US site for ateganosine Phase 2 trial

Winship Cancer Institute of Emory University joins THIO-101, evaluating ateganosine as a third-line NSCLC therapy in checkpoint-inhibitor-resistant patients.
Winship Cancer Institute of Emory University joins THIO-101, evaluating ateganosine as a third-line NSCLC therapy in checkpoint-inhibitor-resistant patients.
Biologics
Regulatory Science

Sanofi wins Japan approval for Sarclisa subcutaneous formulation

Japan's MHLW has approved isatuximab SC across multiple myeloma indications, with an on-body injector application still under regulatory review.
Japan's MHLW has approved isatuximab SC across multiple myeloma indications, with an on-body injector application still under regulatory review.

FocalTherics partners with MellingMedical to bring HIFU to VA system

FocalTherics will offer its Focal One Robotic HIFU prostate cancer platform to Veterans Affairs and DoD facilities via MellingMedical's federal supply schedule.
FocalTherics will offer its Focal One Robotic HIFU prostate cancer platform to Veterans Affairs and DoD facilities via MellingMedical's federal supply schedule.
Biologics

IMF ASCENT trial shows 82% five-year PFS in smouldering myeloma

Phase 2 ASCENT data presented at EHA 2026 showed 97% overall response and 85% MRD negativity in high-risk smouldering myeloma patients.
Phase 2 ASCENT data presented at EHA 2026 showed 97% overall response and 85% MRD negativity in high-risk smouldering myeloma patients.
Biologics

Roche files sBLA for Lunsumio-Polivy combo in relapsed LBCL

The FDA has accepted Roche's supplemental BLA for mosunetuzumab plus polatuzumab vedotin in relapsed or refractory large B-cell lymphoma, with a decision expected
The FDA has accepted Roche's supplemental BLA for mosunetuzumab plus polatuzumab vedotin in relapsed or refractory large B-cell lymphoma, with a decision expected
Biologics

Zelluna ASA raises NOK 58m ahead of first TCR-NK clinical data

The Oslo-listed cell therapy company closed a private placement and retail offering to fund its MAGE-A4-targeting TCR-NK candidate as initial trial
The Oslo-listed cell therapy company closed a private placement and retail offering to fund its MAGE-A4-targeting TCR-NK candidate as initial trial
Regulatory Science

NeOnc secures UAE IND clearance for brain tumour drug NEO212

NeOnc Technologies has gained Abu Dhabi regulatory clearance for NEO212 after Phase 1 established a recommended dose in recurrent glioblastoma patients.
NeOnc Technologies has gained Abu Dhabi regulatory clearance for NEO212 after Phase 1 established a recommended dose in recurrent glioblastoma patients.
Regulatory Science

NovaBridge wins FDA Fast Track for givastomig in gastric cancer

NovaBridge Biosciences has secured Fast Track Designation for givastomig in first-line HER2-negative metastatic gastric cancer, with a Phase 3 trial expected to start
NovaBridge Biosciences has secured Fast Track Designation for givastomig in first-line HER2-negative metastatic gastric cancer, with a Phase 3 trial expected to start
Diagnostics

Aptose reports 86% response rate in AML triplet therapy trial at EHA

Phase 1/2 TUSCANY data show tuspetinib plus venetoclax and azacitidine achieved deep remissions across diverse AML mutations, including historically difficult
Phase 1/2 TUSCANY data show tuspetinib plus venetoclax and azacitidine achieved deep remissions across diverse AML mutations, including historically difficult

Context Therapeutics: CTIM-76 hits 29% ORR in ovarian cancer

Phase 1 interim data showed a 29% confirmed overall response rate in heavily pretreated platinum-resistant ovarian cancer patients, with mostly Grade 1 adverse events.
Phase 1 interim data showed a 29% confirmed overall response rate in heavily pretreated platinum-resistant ovarian cancer patients, with mostly Grade 1 adverse events.

Enterome EO2463 hits 74% ORR in iNHL combo cohort at EHA 2026

Interim SIDNEY trial data show durable CD8 T cell responses and a 41% monotherapy ORR in indolent non-Hodgkin lymphoma patients on watchful waiting.
Interim SIDNEY trial data show durable CD8 T cell responses and a 41% monotherapy ORR in indolent non-Hodgkin lymphoma patients on watchful waiting.
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