Oncology

FDA expands approval for Shorla’s JYLAMVO for paediatric patients

The US Food and Drug Administration (FDA) has granted expanded approval to Shorla Oncology’s JYLAMVO (methotrexate) for use in paediatric indications.

Kivu Bioscience secures $92m in Series A funding for ADC development

Kivu Bioscience has completed a $92m Series A funding round, spearheaded by Novo Holdings to propel the development of next-generation antibody-drug conjugates (ADCs).

FDA grants IND clearance for RiboX’s RXRG001

The US Food and Drug Administration (FDA) has granted clearance for RiboX Therapeutics’ investigational new drug (IND) application to commence a Phase I/IIa clinical trial of RXRG001, circular RNA therapy.

Lyell signs agreement to acquire ImmPACT Bio

Lyell Immunopharma has entered into a definitive agreement for the acquisition of ImmPACT Bio USA, a move that is expected to prioritise its pipeline to focus on chimeric antigen receptor (CAR) T-cell therapies.

TerSera acquires global rights to MacroGenics’ MARGENZA for breast cancer treatment

MacroGenics has granted global rights to the breast cancer drug MARGENZA (margetuximab) to TerSera Therapeutics.

Novartis gets positive CHMP opinion for Kisqali in early breast cancer

Novartis has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending marketing authorisation for Kisqali (ribociclib) as an adjuvant treatment for certain early breast cancer patients.

FDA grants priority review for AstraZeneca’s Calquence sNDA

The US Food and Drug Administration (FDA) has accepted and granted priority review to AstraZeneca's supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).

FDA grants fast track status for Volastra’s VLS-1488 to treat ovarian cancer

The US Food and Drug Administration (FDA) has granted fast track designation for Volastra Therapeutics’ KIF18A inhibitor, VLS-1488, to treat patients with platinum-resistant high-grade serous ovarian cancer (HGSOC).

FDA grants fast track designation for Elevation Oncology’s EO-3021

The US Food and Drug Administration (FDA) has granted fast track designation for Elevation Oncology’s EO-3021, a treatment for patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer.