Oncology

NeoImmuneTech receives orphan drug status for NT-I7 to treat ARS

NeoImmuneTech has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational drug, NT-I7 (efineptakin alfa) (rhIL-7-hyFc), to treat Acute Radiation Syndrome (ARS), an acute illness.

Juventas receives NMPA market approval for cell therapy

CASI Pharmaceuticals’ partner Juventas Cell Therapy has received market approval from the China National Medical Products Administration (NMPA) for Inaticabtagene Autoleucel (CNCT 19).

Prelude announces partnership with AbCellera for oncology ADCs

Prelude Therapeutics has announced a partnership with AbCellera for first-in-class precision antibody drug conjugates (ADCs) in oncology.

Shorla raises $35m via Series B to progress oncology product portfolio

Shorla Oncology has raised $35m in a Series B funding round to progress its oncology product portfolio.

Orano Med and Orbit partner for radionuclide therapies discovery

Orano Med and Orbit Discovery have entered into a partnership for the discovery of specific peptide receptor radionuclide therapies against cancer cells and advance new radiopharmaceuticals development.

US FDA issues guidance for Citius’ lymphoma treatment BLA

The US Food and Drug Administration (FDA) has issued additional guidance to Citius Pharmaceuticals on the resubmission of a biologics license application (BLA) for Lymphir (denileukin diftitox) to treat cutaneous T-cell lymphoma (CTCL).

Procaps Group and BDR sign agreement for oncology molecules

Procaps Group has signed an agreement with BDR Pharmaceuticals International for 27 oncology molecules for Latin America, including 20 Tirosyne Kinase Inhibitors (TKIs).

Alentis’ ALE.C04 receives fast track designation from FDA

Alentis Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its antibody ALE.C04 to treat patients with recurrent or metastatic, CLDN1-positive head and neck squamous cell carcinoma (HNSCC).

CanariaBio receives orphan drug designation for pancreatic cancer therapy

CanariaBio has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational drug product, MAb-AR20.5, targeting pancreatic cancer.