Oncology

Zuellig Pharma and Regeneron sign deal to supply Libtayo in South Korea and Taiwan

Zuellig Pharma has entered into an exclusive distribution agreement with Regeneron Ireland DAC for the launch and commercialisation of Libtayo (cemiplimab) in the South Korean and Taiwanese markets.

GSK’s B7-H3-targeted ADC receives FDA breakthrough therapy status

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for GSK's investigational B7-H3-targeted antibody-drug conjugate (ADC), GSK5764227 (GSK'227).

FDA grants RMAT designation to AffyImmune’s AIC100 for thyroid cancer

The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation for AffyImmune’s CAR T-cell therapy, AIC100, to treat recurrent anaplastic thyroid cancer (ATC).

Amneal Pharmaceuticals launches ready-to-use injectable FOCINVEZ

US-based Amneal Pharmaceuticals has announced the launch of FOCINVEZ, a ready-to-use injectable for the prevention of nausea and vomiting in chemotherapy patients.

Adicet Bio’s ADI-270 receives FDA Fast Track Designation for kidney cancer treatment

The US Food and Drug Administration (FDA) has granted Fast Track Designation to Adicet Bio's ADI-270, a potential treatment for patients suffering with metastatic/advanced clear cell renal cell carcinoma (ccRCC) who have received treatment with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor.

EU approves AstraZeneca’s Tagrisso combined with chemotherapy for EGFRm NSCLC

The European Commission has approved AstraZeneca's Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.

Alembic receives tentative approval from USFDA for Ivosidenib Tablets

Alembic Pharmaceuticals has announced its tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) submitted for Ivosidenib Tablets, 250mg.

FDA grants fast track status for Full-Life’s prostate cancer treatment

The US Food and Drug Administration (FDA) has granted fast track designation for radiotherapeutics company Full-Life Technologies’ 225Ac-FL-020 to treat metastatic castration-resistant prostate cancer (mCRPC).

FDA grants Fast Track designation to Tubulis’ TUB-040 for ovarian cancer treatment

Tubulis has received Fast Track designation from the US Food and Drug Administration (FDA) for its lead antibody-drug conjugate (ADC), TUB-040, aimed at treating patients with platinum-resistant ovarian cancer.