Merck has secured Fast Track designation from the US Food and Drug Administration (FDA) for MK-2060, its investigational anticoagulant therapy for end-stage renal disease (ESRD).
The Indonesia National Agency for Drug and Food Control, Badan Pengawas Obat dan Makanan (BPOM) has approved Takeda’s Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003).
Oncopeptides has received marketing authorisation from the European Commission (EC) for Pepaxti (melphalan flufenamide, also called melflufen) to treat relapsed refractory multiple myeloma (RRMM) patients.
Inhibrx has received the orphan drug designation from the European Commission (EC) for its INBRX-109 to treat chondrosarcoma.
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).
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