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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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Otsuka and Lundbeck’s sNDA for Rexulti gains US FDA approval

Pharmaceutical Technology

Otsuka Pharmaceutical and H Lundbeck have received approval for the supplemental new drug application (sNDA) from the US Food and Drug Administration for Rexulti (brexpiprazole) to treat agitation associated with dementia due to Alzheimer’s disease.

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How NLP Helps Life Sciences Companies Unlock Insights from Drug Labels

PM360

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

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Click Therapeutics kicks off digital therapy remote trial for migraine

Pharmaceutical Technology

in December 2022, the digital therapy, called CT-132, secured a Breakthrough Device designation from the US Food and Drug Administration (FDA) as an adjunctive preventive treatment for episodic migraine in patients above the age of 18 years. Its use is especially applicable in mental health and neurology.

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Can Hepatitis C drugs reduce symptoms of PTSD?

European Pharmaceutical Review

“Many people have PTSD, but there [are] few effective pharmacologic treatments and limited drug development for PTSD,” commented Gradus. There are two current medications – sertraline and paroxetine – approved by the US Food and Drug Administration (FDA) for treating PTSD symptoms.

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The future of medical cannabis development in Europe

European Pharmaceutical Review

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. 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).

Medical 87
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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.