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. We look forward to our upcoming meeting with the FDA on 1 May 2023 to discuss our planned Phase III clinical programme for XORLO.”

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Food and Drug Administration FDA Pharmacology Food 52

Clarivate

SEPTEMBER 11, 2024

Timely and accurate diagnosis is critical to maximize the efficacy of available interventions – but for most individuals, the diagnostic journey remains long, complex and costly (Alzheimer’s Disease International, 2021; Chiari, 2022; Juganavar, 2023). Currently, of the eight drugs approved by the U.S. 2024; Quanterix, 2024).

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Food and Drug Administration Pharmacology Food FDA 59

European Pharmaceutical Review

JULY 4, 2024

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

Marketing Food and Drug Administration Medicine Prescription 103

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.

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Food and Drug Administration FDA Pharmacology Safety 59

European Pharmaceutical Review

JULY 13, 2023

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).

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Medical Food and Drug Administration Pharmacology Medicine 98

European Pharmaceutical Review

APRIL 13, 2023

As psychedelics diffused into wider society and recreational use increased, some individuals reported…ongoing symptoms after the drugs had left the body” At a time when psychiatry lacked effective medical therapies, the discovery of LSD was of interest.

Medicine 131

Medicine Food and Drug Administration Doctors Medical 131

European Pharmaceutical Review

JULY 18, 2024

What are antibody-drug conjugates and why do they hold potential over other treatment modalities? Antibody drug conjugates (ADCs) are an emerging technology adding significant value to the oncology treatment landscape. Antibody drug conjugate: the “biological missile” for targeted cancer therapy. 2023; 3 Tsuchikama et al.

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Food and Drug Administration Engineering Pharmacology Side effects 59