Regulation

Merck’s end-stage renal disease therapy secures FDA fast track designation

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).

Indonesia approves Takeda’s dengue vaccine Qdenga

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 receives EU marketing authorisation for RRMM therapy

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 gets EC orphan drug designation for chondrosarcoma therapy

Inhibrx has received the orphan drug designation from the European Commission (EC) for its INBRX-109 to treat chondrosarcoma.

China’s NMPA approves InnoCare’s orelabrutinib to treat Marginal Zone Lymphoma

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).

FDA approves Genentech’s sNDA for influenza therapy in children

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.

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.