The International Coalition of Medicines Regulatory Authorities (ICMRA) has released comprehensive guidelines recommending how regulatory bodies can introduce aligned track and trace systems around the world to combat counterfeit or falsified products in global supply...
The US FDA (Food and Drug Administration) has approved Sanofi’s Nexviazymefor to treat patients with rare but potentially fatal muscle disorder, Pompe disease. Pompe disease affects 1 in 40,000 Americans and weakens the heart and skeletal muscles caused by an...
The US Food and Drug Administration (FDA) has rejected Tenapanor for Control of Phosphorus in Kidney Disease, asking for another clinical trial that indicates the drug’s greater benefits before approval. Ardelyx devleoped Tenapanor, an oral inhibitor of the...
The European Commission (EC) has granted approval of a supply contract with Novavax to purchase more than 200 million COVID-19 vaccines. The deal is an attempt to further diversity the EU’s vaccine strategy after betting heavily on their Pfizer and Moderna vaccine...
Aiming to expand the use of Zolgensma, Novartis has announced the launch of a new phase three study following the FDA’s decision to remove restrictions and partial clinical trial hold. Novartis plans to evaluate the use of Zolgensma to treat patients (aged 2-18) for...
The FDA has granted Alkermes fast-tracked designation for Nemvaleukin Alfa (nemvaleukin) to treat patients with mucosal melanoma, following nemvaleukin’s orphan drug designation earlier in the year. Nemvaleukin alfa is Alkermes’ first investigational engineered...
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