Approvals

Amneal submits NDA to US FDA for Parkinson’s disease treatment

Amneal Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for IPX203 to treat Parkinson’s disease (PD).

EC approves Novartis’ Scemblix for chronic myeloid leukemia treatment

The European Commission (EC) has approved Novartis’ Scemblix (asciminib) to treat chronic myeloid leukemia (CML) in adult patients.

Novavax gets MHRA expanded conditional marketing authorisation for Nuvaxovid

Novavax has received expanded conditional marketing authorisation (CMA) from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373).

Japan approves AstraZeneca’s Ultomiris for generalised myasthenia gravis

AstraZeneca has received the Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for Ultomiris (ravulizumab) to treat generalised myasthenia gravis (gMG) in adult patients.

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).