Pharmaceutical Technology
APRIL 24, 2023
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.
PM360
NOVEMBER 29, 2022
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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European Pharmaceutical Review
AUGUST 23, 2022
The researchers studied 254 VA patients who were diagnosed with PTSD and hepatitis C between October 1999 and September 2019. Patients’ symptoms were monitored for PTSD and hepatitis C virus between two clinical visits over eight to 12 weeks. MDMA-assisted therapy successful in PTSD patients.
Pharmaceutical Technology
APRIL 26, 2023
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.
Pharmaceutical Technology
MAY 11, 2023
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.
European Pharmaceutical Review
JULY 13, 2023
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. 3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside.
Pharmaceutical Technology
AUGUST 12, 2022
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.
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