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FDA clears Wandercraft’s Eve self-balancing exoskeleton for personal use in adults with spinal cord injury
The clearance extends Wandercraft’s self-balancing exoskeleton technology beyond supervised rehabilitation, allowing eligible adults with spinal cord injuries to use Eve for hands-free upright mobility and daily activities with a trained companion.

nuaxia
23 hours ago2 min read


FDA grants accelerated approval to Zenbexus combination for previously treated multiple myeloma
The approval provides adults who have received at least one prior line of therapy with a new iberdomide-based combination, supported by higher minimal residual disease-negative complete response rates than the comparator regimen in EXCALIBER-RRMM.

nuaxia
23 hours ago2 min read


HanchorBio partners with Taiwan Cancer Moonshot team to advance precision immunotherapy development
The collaboration combines HanchorBio's immuno-oncology platform with Taiwan's national precision oncology programme to support biomarker-driven clinical development and translational research.

nuaxia
2 days ago2 min read


BeOne and Revolution Medicines partner on RAS-targeted oncology combinations and Asian licensing deal
The collaboration pairs BeOne’s oncology pipeline with four clinical-stage RAS(ON) inhibitors while giving BeOne regional rights to the Revolution Medicines assets across selected Asian markets.

nuaxia
3 days ago3 min read


FDA approves Labcorp PGDx elio tissue complete CDx for BRAF-targeted therapy selection in advanced melanoma
The next-generation sequencing companion diagnostic identifies BRAF V600E and V600K variants, helping clinicians determine which melanoma patients may be eligible for FDA-approved BRAF or BRAF/MEK targeted therapies.

nuaxia
4 days ago2 min read


Sobi licenses lacutamab from Innate Pharma in T-cell lymphoma deal worth up to $580 million
The partnership gives Sobi potential global commercial and development rights to the first-in-class anti-KIR3DL2 antibody while funding Innate’s Phase III programme in cutaneous T-cell lymphoma.

nuaxia
5 days ago3 min read


Sobi moves to acquire full control of Pint Pharma to expand Latin American rare disease platform
The transaction would give Sobi full ownership of a specialist commercialisation platform spanning seven Latin American markets, building on its $105 million investment in Pint Pharma in 2025.

nuaxia
5 days ago3 min read


FDA grants accelerated approval to Tudriqev for PD-1-refractory advanced melanoma
The engineered oncolytic viral therapy, used with nivolumab, provides a new treatment option for adults with unresectable cutaneous melanoma that has progressed despite prior PD-1-based immunotherapy.

nuaxia
Aug 72 min read


FDA proposes streamlined nonclinical safety studies for antibody-drug conjugates and other oncology biologics
The draft guidance could reduce reliance on animal studies for some oncology products while increasing the importance of analytical characterisation and weight-of-evidence approaches during development.

nuaxia
Aug 72 min read


Pathos AI licenses first-in-class bispecific ADC JSKN016 from Alphamab Oncology in deal worth up to $4.8 billion
Pathos AI licenses first-in-class bispecific ADC JSKN016 from Alphamab Oncology in deal worth up to $4.8 billion

nuaxia
Aug 62 min read


FDA approves Reditux as rituximab biosimilar for B-cell malignancies and autoimmune diseases
The approval adds another US biosimilar option for rituximab-treated conditions, including non-Hodgkin lymphoma and chronic lymphocytic leukaemia, although commercial availability and pricing have not yet been confirmed.

nuaxia
Aug 62 min read


FDA expands Truqap approval to PTEN-deficient metastatic hormone-sensitive prostate cancer
The biomarker-selected regimen adds an AKT inhibitor to abiraterone and prednisone for adults with newly diagnosed metastatic disease whose tumours show PTEN deficiency.

nuaxia
Aug 62 min read


FDA approves Pluvicto with androgen receptor pathway inhibitor for PSMA-positive metastatic hormone-sensitive prostate cancer
The expanded indication moves radioligand therapy into an earlier stage of metastatic prostate cancer, providing an additional treatment option for eligible patients before progression to castration-resistant disease.

nuaxia
Aug 32 min read


EU approves Etcamah and advances Enhertu combination for biomarker-defined breast cancers
The two regulatory decisions could expand first-line treatment options for patients with ESR1-mutant ER-positive disease and HER2-positive metastatic breast cancer, although Enhertu still requires European Commission approval.

nuaxia
Jul 312 min read


FDA approves SimpleScreen™ CRC blood test for colorectal cancer screening in average-risk adults
The approval provides adults aged 45 years and older at average risk of colorectal cancer with an additional blood-based screening option, expanding access for individuals who are overdue for screening.

nuaxia
Jul 292 min read


CHMP backs Trodelvy plus Keytruda for first-line PD-L1-positive metastatic breast cancer
If authorised, the combination would add an antibody-drug conjugate-based first-line option for eligible European patients with unresectable locally advanced or metastatic triple-negative breast cancer.

nuaxia
Jul 272 min read


Lupin licenses two oncology programmes to Kaveri Therapeutics for an 82.2% equity stake
The spin-out creates a dedicated US oncology company to raise capital and advance Lupin’s PRMT5 and SOS1 programmes through global clinical development.

nuaxia
Jul 222 min read


Kelun’s Merck-Partnered ADC Delivers Phase III Win in First-Line PD-L1-Negative Lung Cancer
Sacituzumab tirumotecan plus Keytruda improves progression-free survival in advanced NSCLC, expanding potential role of ADC-immunotherapy combinations.

nuaxia
Jul 173 min read


FDA Approves Celcuity’s Revtorpyk for PI3K-Pathway Targeted Breast Cancer Treatment
The approval of Revtorpyk (gedatolisib) gives Celcuity a new treatment option for HR-positive, HER2-negative breast cancer patients without PIK3CA mutations, following positive Phase III VIKTORIA-1 data showing improved progression-free survival.

nuaxia
Jul 153 min read


AstraZeneca Acquires Global Rights to Dizal’s Zegfrovy in $1.5bn Lung Cancer Deal
The agreement expands AstraZeneca’s oncology portfolio with an oral EGFR inhibitor for non-small-cell lung cancer, as Dizal seeks to broaden Zegfrovy’s use into earlier lines of treatment.

nuaxia
Jul 153 min read
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