Remove FDA Remove Food Remove Patients Remove Pharmacology
article thumbnail

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.

article thumbnail

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. The regulator accepted and gr anted priority review for the sNDA in January 2023.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Click Therapeutics kicks off digital therapy remote trial for migraine

Pharmaceutical Technology

Patients will receive the digital therapy through their mobile phone applications over a 12-week period, and its efficacy will be evaluated based on the difference in the number of monthly migraine days. According to the company, patients often do not achieve full remission with a solely pharmacotherapeutic approach.

article thumbnail

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

article thumbnail

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. Senza HFX iQ is the first and only Artificial Intelligence-based SCS system that learns from patients. “Pain is variable from patient to patient and over time. Keith Grossman, Chairman and CEO of Nevro.

FDA 52
article thumbnail

The future of medical cannabis development in Europe

European Pharmaceutical Review

1,2 Moreover, except for countries such as Czechia, Denmark and Germany, the cost of these medications is borne by the patient, rather than national insurance or healthcare systems. 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 81
article thumbnail

Q32 Bio and Horizon partner to develop autoimmune disease treatment

Pharmaceutical Technology

Recently, Q32 concluded a Phase I clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety of ADX-914, which showed a pharmacological effect on T cells in healthy subjects. antibody, ADX-914 re-regulates adaptive immune function by hindering IL-7 and TSLP-facilitated signalling.