Regulation

Taiwan FDA accepts Everest’s NDA for xerava to treat intra-abdominal infections

The Taiwan Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for Everest Medicines’ xerava (eravacycline) to treat complicated intra-abdominal infections (cIAI).

FDA grants EUA for Bavarian Nordic’s Jynneos vaccine for monkeypox

Bavarian Nordic’s vaccine, Jynneos, has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) to increase vaccine supply for monkeypox.

US FDA grants priority review to Gamida Cell’s BLA for omidubicel

The US Food and Drug Administration (FDA) has granted priority review to Gamida Cell’s filing of biologics license application (BLA) for omidubicel to treat blood cancer patients who need an allogenic hematopoietic stem cell transplant.

Omeros gets FDA Orphan Drug Designation for PNH therapy

Omeros has received orphan drug designation from the US Food and Drug Administration (FDA) for OMS906 to treat paroxysmal nocturnal hemoglobinuria (PNH).

QBiotics receives IND application approval for Phase II solid tumours therapy trial

The US Food and Drug Administration (FDA) has approved QBiotics Group’s Investigational New Drug (IND) application to commence the Phase II clinical trial (QB46C-H07) of tigilanol tiglate.

FDA grants fast track designation for Anthos’ cancer associated thrombosis therapy

The US Food and Drug Administration (FDA) has granted fast track designation for Anthos Therapeutics’ investigational Factor XI inhibitor, abelacimab, to treat thrombosis associated with cancer.

US FDA grants priority review to Eisai’s BLA for lecanemab

The US Food and Drug Administration (FDA) has granted priority review for Eisai’s biologics license application (BLA) under the accelerated approval pathway, for lecanemab to treat early Alzheimer’s Disease (AD)

Janssen secures FDA breakthrough designation for myeloma therapy

The Janssen Pharmaceutical Companies of Johnson & Johnson has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for talquetamab to treat relapsed or refractory multiple myeloma in adult patients.

Sanofi receives marketing authorisation from EC for Pompe disease therapy

Sanofi has received marketing authorisation from the European Commission (EC) for Nexviadyme (avalglucosidase alfa) to treat the complete spectrum of infantile-onset Pompe disease (IOPD) and late-onset Pompe disease (LOPD).