Future Medicine India – Drug Approvals Drug Approvals Archives | Future Medicine India

Drug Approvals

Triple-combo inhaler for COPD in Japan

AstraZeneca announced that Breztri Aerosphere (budesonide/ glycopyrronium/ formoterol fumarate) has been approved in Japan as a triple-combination therapy to relieve symptoms of chronic obstructive pulmonary disease (COPD).

FM
Read More..

Ravulizumab to treat PNH in Japan

Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved ravulizumab (Ultomiris) for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH).

FM

Triumvira’s T-cell candidate for B-cell malignancies

The US FDA and Health Canada have cleared Triumvira’s Investigational New Drug (IND) and Clinical Trial Applications (CTA) for its novel T cell therapy product TAC01-CD19 in patients with CD19-positive B-cell malignancies.

FM

Entrectinib to treat patients with NTRK solid tumours

Entrectinib (Rozlytrek) has been granted marketing approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours.

FM

Olaparib for BRCA-mutated advanced ovarian cancer in EU

AstraZeneca and MSD Inc announced that the European Commission (EC) has approved olaparib (Lynparza) as a 1st-line maintenance treatment for women with BRCA- mutated advanced ovarian cancer.

FM

Liraglutide for children with type 2 DM

The US FDA has approved liraglutide (Victoza) injection for the treatment of paediatric patients 10 years or older with type 2 diabetes.

FM

Quizartinib to treat relapsed FLT3-ITD AML in Japan

Japanese ministry of health has approved quizartinib (Vanflyta), an oral FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukaemia (AML), as detected by an MHLW-approved test.

FM