OKYO Pharma has announced plans to file an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for OK-101 to treat Dry Eye Disease (DED), in the fourth quarter (Q4) of this year.
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).
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.
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