Regulation

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).

EMA CHMP recommends marketing authorisation for Novartis’ PNH treatment

Novartis has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to grant marketing authorisation for Fabhalta (iptacopan) to treat adults with paroxysmal nocturnal haemoglobinuria (PNH) who suffer from haemolytic anaemia.

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).

FDA committee recommends BMS-2seventy’s Abecma

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted in favour of Bristol Myers Squibb (BMS) and 2seventy bio’s Abecma (idecabtagene vicleucel) for treating triple-class exposed relapsed or refractory multiple myeloma.

Johnson & Johnson files sBLA for ulcerative colitis treatment

Johnson & Johnson has filed a supplemental biologics license application (sBLA) with the US Food and Drug Administration (FDA) seeking approval for TREMFYA (guselkumab)to treat moderately to severely active ulcerative colitis (UC).