European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has announced their approval of diroximel fumarate (Vumerity, Biogen Inc) for adults diagnosed with relapsing-remitting multiple sclerosis (MS). Although Diroximel fumarate is...
The US FDA (Food & Drug Administration) and the EMA (European Medicines Agency) have launched a joint pilot designed to give parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines (as they’re referred to in the EU). The aim of...
The World Health Organization (WHO) has announced that they plan on replicating Moderna’s COVID-19 vaccine to boost COVID-19 vaccination rates and production in Africa. Although efforts have yet to yield results, the plans will allow for more developing countries to...
Biopharmaceutical company Axsome Therapeutics, known for developing innovative therapies for central nervous system (CNS) disorders, announced that the FDA (Food and Drug Administration) has accepted their New Drug Application (NDA) for AXS-07 for acute migraine...
The US FDA (Food and Drug Administration) has accepted for review BeiGene’s Biologics License Application (BLA) for its anti-PD-1 antibody tislelizumab to treat patients with reoccurring locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)...
The Ministry of Health and Prevention (MOHAP) in the United Arab Emirates (UAE) has granted BioCryst Pharmaceuticals marketing authorization for their oral medication ORLADEYO® (berotralstat) to help prevent frequent hereditary angioedema (HAE) attacks in patients 12...
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