Approvals

NICE recommends Novartis’ CAR-T therapy for leukaemia

The UK National Institute for Health and Care Excellence (NICE) has recommended the routine use of Novartis' tisagenlecleucel (Kymriah), a chimeric antigen receptor T-cell (CAR-T) therapy, for children and young adults aged up to 25 years with B-cell acute lymphoblastic leukaemia (ALL).

FDA approves ViiV Healthcare’s Dovato for adolescent HIV treatment

The US Food and Drug Administration (FDA) has approved ViiV Healthcare’s Dovato (dolutegravir/lamivudine) to treat HIV-1 infection in adolescents.

Solid Biosciences’ SGT-003 receives rare pediatric disease designation

Solid Biosciences has received the US Food and Drug Administration’s (FDA) rare pediatric disease designation for its gene therapy candidate for Duchenne muscular dystrophy (Duchenne), SGT-003.

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).

FDA approves Italfarmaco’s Duvyzat for DMD treatment

The US Food and Drug Administration (FDA) has approved Italfarmaco's Duvyzat (givinostat) to treat Duchenne Muscular Dystrophy (DMD) in individuals aged six years and above.

Takeda gets approval for acute lymphoblastic leukemia treatment sNDA

Takeda has received accelerated approval for a supplemental new drug application (sNDA) from the US Food and Drug Administration (FDA) for ICLUSIG (ponatinib) to treat Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

US FDA grants ODD to NeoImmuneTech’s NT-I7 for pancreatic cancer treatment

NeoImmuneTech, a company specialising in T cell-focused therapeutics, has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its NT-I7 (efineptakin alfa) (rhIL-7-hyFc), for the treatment of pancreatic cancer.

Oricell’s OriCAR-017 application secures FDA IND clearance

Oricell Therapeutics has announced the clearance of its Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) for OriCAR-017, a new CAR-T cell therapy targeting GPRC5D, for the treatment of relapsed/refractory multiple myeloma (R/R MM).

Zokinvy gets Japanese approval for Progeria treatment

The Progeria Research Foundation (PRF) has announced the Japanese approval of Zokinvy (lonafarnib) for treating Progeria and processing-deficient Progeroid Laminopathies (PL).