Regulatory Approvals
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FDA approves AbbVie’s Juvmo for adults with Parkinson’s disease in US
The approval gives AbbVie another Parkinson’s product following its acquisition of Cerevel Therapeutics.
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Pharmakina completes Africa CDC prequalification for regional pharmaceutical procurement
The company has developed an integrated value chain around cinchona cultivation, quinine production and pharmaceutical manufacturing, with malaria treatment forming an important part of its activities.
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WHO assesses EFDA Medicines Laboratory in Ethiopia for Global Quality Listing
The assessment identified strengths and areas for improvement, while the technical sessions gave EFDA experts practical experience relevant to meeting WHO requirements.
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Ultragenyx wins FDA approval for Fayuvi gene therapy for Sanfilippo syndrome
Patients have an average lifespan of about 15 years, while an estimated 3,000 to 5,000 people in commercially accessible markets live with the condition.
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Curium enters radioligand therapy market with FDA approval of Bexlutry
Developed by Curium, Bexlutry is a lutetium-177 dotatate injection that references Novartis’ Lutathera, which is approved to treat gastroenteropancreatic neuroendocrine tumors (GEP NETs).
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China approves Lumirix for mild to moderate atopic dermatitis
Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by recurring symptoms, with the CIC report indicating that China had more than 54 million people living with AD in 2024.
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World Health Organization taps South Korean regulatory expertise to strengthen global workforce capacity
Through the new collaborating centre, WHO will expand access to structured, competency-based regulatory training and support the development of a stronger workforce capable of regulating medicines and vaccines.
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WHO issues emergency guidance on Ervebo use during Bundibugyo virus outbreaks
The guidance recommends that Ervebo® should currently be used against Bundibugyo virus (BDBV) only within a research protocol.
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Lundbeck’s Asedebart gains EU Orphan Designation for Cushing’s Syndrome
Cushing’s syndrome of endogenous origin occurs when the body produces excessive amounts of cortisol and other steroid hormones.
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Priovant launches Lisraya in US following historic FDA approval for dermatomyositis
The decision follows positive results from the Phase III VALOR trial (NCT05437263), which showed that Lisraya improved several measures of dermatomyositis disease activity.