US Food and Drug Administration (FDA)
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FDA accepts Kowa’s K-911 glaucoma eye drop application for review
Kowa is seeking approval based on results from the pivotal Phase III Mont Blanc and Denali trials.
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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.
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Gossamer Bio secures US$250M to advance seralutinib toward FDA review
Seralutinib is an investigational treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
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Johnson & Johnson gains FDA clearance for MONARCH QUEST 3 bronchoscopy system
The new software incorporates AI-powered nodule segmentation, which is designed to generate more precise boundaries around lung nodules during pre-procedural planning.
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Labcorp expands precision oncology portfolio with FDA clearance for melanoma test
The approval allows the company’s PGDx elio tissue complete CDx to be used in hospitals and clinical laboratories across the United States to help identify patients who may benefit from targeted treatment.
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Takeda secures FDA approval for oral orexin agonist Orzeyful in US market
The approval expands Orzeyful’s commercial reach following its authorization in China in July 2026, marking another milestone in Takeda’s global launch strategy.
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RadNet subsidiary DeepHealth gains 510(k) FDA approval for breast ultrasound AI
DeepHealth Breast Ultrasound automates several stages of breast ultrasound examinations, including lesion detection, characterisation and reporting.
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FDA approves Otsuka’s Simtriyo as first-in-class NDSRI for ADHD treatment
The approval makes Simtriyo the first norepinephrine, dopamine, serotonin reuptake inhibitor (NDSRI) for ADHD and gives Otsuka what Jefferies analysts described as its “next major CNS launch.”
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FDA approves Outlook Therapeutics’ Lytenava as first ophthalmic Bevacizumab for wet AMD
Lytenava contains bevacizumab, an anti-vascular endothelial growth factor (anti-VEGF) antibody that inhibits the growth of abnormal blood vessels that can damage the retina.