Drug Discovery

Genmab and Pfizer’s TIVDAK sBLA secures full FDA approval

Genmab and Pfizer have announced that the US Food and Drug Administration (FDA) granted full approval to TIVDAK’s (tisotumab vedotin-tftv) supplemental Biologics License Application (sBLA) to treat patients with recurrent or metastatic cervical cancer who have experienced disease progression on or after chemotherapy.

FDA approves Ractigen Therapeutics’ RAG-01 IND for bladder cancer

Ractigen Therapeutics has received approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for saRNA therapy RAG-01.

SK pharmteco signs agreement to manufacture Ferring’s ADSTILADRIN

Ferring Pharmaceuticals and SK pharmteco have entered into an agreement to increase commercial manufacturing capacity for Ferring’s ADSTILADRIN (nadofaragene firadenovec-vncg), ensuring a long-term supply of the non-replicating adenoviral vector-based gene therapy.

Telix Pharmaceuticals secures FDA fast track status for TLX101-CDx

Telix Pharmaceuticals has received fast track designation from the US Food and Drug Administration (FDA) for its investigational glioma imaging product, TLX101-CDx (Pixclara).

Immuno-oncology company Portage Biotech to evaluate strategic alternatives

Clinical-stage immuno-oncology company Portage Biotech has announced plans to expand its assessment of strategic alternatives.

TORL BioTherapeutics secures $158m for oncology pipeline development

Clinical-stage biotechnology company TORL BioTherapeutics has announced the closure of an oversubscribed $158m Series B-2 financing round.

Invenra, Astellas sign bispecific antibody discovery agreement

Invenra and Astellas Pharma have signed a strategic research agreement in therapeutic bispecific antibody discovery.

US FDA grants breakthrough status to Dizal’s sunvozertinib

Dizal Pharmaceutical has obtained breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its sunvozertinib for the first-line treatment of individuals with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.

US FDA grants orphan drug designation to Biostar Pharma’s utidelone

Biostar Pharma has announced that its pipeline product, utidelone injectable (UTD1), has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for the treatment of breast cancer brain metastasis (BCBM).