AnHeart Therapeutics and NewG Lab Pharma subsidiary NewG Lab Therapeutics have received orphan drug designation in Korea for the next-generation tyrosine kinase inhibitor (TKI), taletrectinib, to treat advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
The US Food and Drug Administration (FDA) has approved Revance Therapeutics’ Daxxify (DaxibotulinumtoxinA-lanm) for injection to temporarily improve moderate to severe frown lines (glabellar lines) in adults.
China’s National Medical Products Administration (NMPA) has approved AstraZeneca’s Forxiga (dapagliflozin) to treat chronic kidney disease (CKD) in adult patients who are at risk of progression with and without type-2 diabetes (T2D).
Boehringer Ingelheim has received the US Food and Drug Administration (FDA) approval for its monoclonal antibody, spesolimab, to treat adult patients with generalized pustular psoriasis (GPP) flares.
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).
The European Commission (EC) has approved Novartis’ Scemblix (asciminib) to treat chronic myeloid leukemia (CML) in adult patients.
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).
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 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).
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