approvals
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EDE approves Jascayd for treating idiopathic pulmonary fibrosis
Jascayd® acts as a selective inhibitor of phosphodiesterase-4B (PDE4B), a biological pathway linked to inflammation and fibrotic processes in the lungs.
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Zai Lab accelerates global launch plans for Zoci with landmark European ODD
The EMA Committee for Orphan Medicinal Products supported the designation after recognising a strong unmet need in neuroendocrine carcinomas.
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Akeso secures China approval for Psoriasis Biologic Gumokimab
The approval adds a new option in the growing IL-17 inhibitor class and strengthens the company’s dermatology portfolio.
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UK’s MHRA approves pediatric EURneffy nasal spray for anaphylaxis
Anaphylaxis occurs when the immune system overreacts to a substance it perceives as harmful, triggering symptoms that can rapidly become life-threatening.
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CinnaGen secures historic European approval for osteoporosis biosimilar Zandoriah
The approval allows the company to market the medicine across all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway, subject to national pricing, reimbursement, and market-access requirements.
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Japan’s MHLW approves Boehringer’s Jascayd as first PDE4B inhibitor for lung fibrosis
Jascayd acts as the first phosphodiesterase 4B (PDE4B) inhibitor approved for these indications, offering both antifibrotic and immunomodulatory activity.
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Kyowa Kirin expands FDA-approved use of Crysvita for adults with XLH
The treatment is approved in the United States for adults and pediatric patients aged six months and older, making it one of the few targeted therapies available for this condition.
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Merck expands HIV portfolio with FDA approval of Idvynso single-tablet regimen
The tablet combines 100 mg of doravirine and 0.25 mg of islatravir in a once-daily formulation.
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European Commission approves Merck’s Enflonsia for RSV prevention in infants
The approval grants the pharmaceutical giant the right to market Enflonsia across all 27 member states of the European Union, as well as Iceland, Liechtenstein, and Norway.
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FDA clears Prodeon Medical’s Urocross expander for non-permanent BPH Treatment
GlobalData analysis projects that the global nephrology and urology device market, which includes BPH treatments, will reach almost USD12 billion in 2035, up from around USD8.6 billion in 2024.