China’s National Medical Products Administration (NMPA) Centre for Drug Evaluation (CDE) has accepted InnoCare Pharma’s supplemental New Drug Application (sNDA) for orelabrutinib to treat relapsed or refractory Marginal Zone Lymphoma (R/R MZL).
The US Food and Drug Administration (FDA) has approved Genentech’s supplemental new drug application (sNDA) for xofluza (baloxavir marboxil) to treat influenza in children.
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).
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.
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 has received orphan drug designation from the US Food and Drug Administration (FDA) for OMS906 to treat paroxysmal nocturnal hemoglobinuria (PNH).
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.
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.
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)
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.
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