Approvals

EMA’s CHMP recommends EU approval for AstraZeneca and Merck’s selumetinib

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended conditional marketing authorisation for AstraZeneca and Merck’s selumetinib to treat paediatric patients aged three years and older with neurofibromatosis type 1 (NF1), symptomatic and inoperable plexiform neurofibromas (PN).

US clearance granted for AstraZeneca’s proposed acquisition of Alexion

The US Federal trade Commission review has granted clearance for AstraZeneca’s proposed acquisition of Alexion Pharmaceuticals, achieving an important milestone in the completion process.

GSK and Vir announce EMA review of VIR-7831 for early treatment of Covid-19

GlaxoSmithKline and Vir Biotechnology have announced the European Medicines Agency (EMA) review of VIR-7831 (GSK4182136) for the early treatment of Covid-19.

Trodelvy granted accelerated approval by USFDA for metastatic urothelial cancer

Gilead Sciences has announced the accelerated approval of Trodelvy (or sacituzumab govitecan-hziy) by the US Food and Drug Administration (FDA) in the treatment of locally advanced or metastatic urothelial cancer (UC) in adult patients.

AbbVie presents applications to FDA and EMA for approval of SKYRIZI in psoriatic arthritis

AbbVie has submitted applications seeking approval for SKYRIZI (risankizumab-rzaa, 150 mg) and SKYRIZI (risankizumab, 150 mg) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively, for the treatment of adults with active psoriatic arthritis.

USFDA extends review period for Eli Lilly and Incyte’s sNDA for baricitinib

The US Food and Drug Administration (FDA) has extended the review period for Eli Lilly and Incyte’s supplemental New Drug Application (sNDA) for OLUMIANT (baricitinib).

AbbVie announces extension of USFDA review period for Rinvoq sNDA

The US Food and Drug Administration (FDA) has extended the review period for AbbVie’s supplemental New Drug Application (sNDA) for Rinvoq (upadacitinib).

USFDA approves Abecma to treat relapsed or refractory multiple myeloma

The US Food and Drug Administration (USFDA) has approved Bristol Myers Squibb (BMS) and bluebird bio’s Abecma (idecabtagene vicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell therapy.

Japan approves Bristol Myers Squibb’s B-cell lymphoma therapy

Bristol Myers Squibb has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for its Breyanzi (lisocabtagene maraleucel; liso-cel) to treat patients suffering from relapsed or refractory (R/R) large B-cell lymphoma (LBCL) and R/R follicular lymphoma.