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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few?

Marketing 103
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US FDA grants orphan drug status for XORTX’s oxypurinol

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to XORTX Therapeutics’ oxypurinol to treat autosomal dominant polycystic kidney disease (ADPKD) patients. The company noted that the ODD from the FDA is not an approval for the use of XORLO, a formulation of oxypurinol.

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Early diagnosis in Alzheimer’s disease: A first step towards better care

Clarivate

Personalized care relies on pharmacological and non-pharmacological interventions aimed at (temporarily) relieving cognitive and non-cognitive symptoms (Alzheimer’s Association, n.d.; Food and Drug Administration, 2023 and 2024). FDA cleared the first CSF diagnostic test based on the detection of Aβ40/Aβ42 (U.S.

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The potential of virtual reality-based therapy for serious mental disorders

Pharmaceutical Technology

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. million people in the UK and 2.7

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Patents: a necessary evil?

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has recently expressed concern to the US PTO about some types of innovator patent strategies that potentially delay generic entry into the market. FDA highlighted that over three quarters of new patents in the Orange Book between 2005 and 2015 were assigned to existing drugs.

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Nevro Announces FDA Approval of HFX iQ™ Spinal Cord Stimulation System to Personalize the Treatment of Chronic Pain

Legacy MEDSearch

Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. market launch planned for early 2023. See Full Press Release at the Source: Nevro Announces FDA Approval of HFX iQ Spinal Cord Stimulation System to Personalize the Treatment of Chronic Pain. this quarter, with a broad U.S.

FDA 52
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The future of medical cannabis development in Europe

European Pharmaceutical Review

It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA). In the future, by adopting these novel approaches to drug development we may see an increase in the number of medications receiving market authorisation. British journal of pharmacology.

Medical 98