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.”

Food and Drug Administration 52

Food and Drug Administration FDA Pharmacology Food 52

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.

Food and Drug Administration 59

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).

Medical 82

Medical Food and Drug Administration Pharmacology Medicine 82

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 112

Medicine Food and Drug Administration Doctors Government 112

European Pharmaceutical Review

FEBRUARY 14, 2024

The development of drug products containing live anaerobic bacterial strains as the active pharmaceutical ingredient and where potency and shelf-life is typically associated with viable cell quantification, poses unique challenges when compared to both small and large molecule development therapeutics.

Food and Drug Administration 75

Food and Drug Administration Manufacturing Engineering Pharmacology 75

Legacy MEDSearch

OCTOBER 13, 2022

Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. market launch planned for early 2023. Senza HFX iQ is the first and only Artificial Intelligence-based SCS system that learns from patients. We believe HFX iQ represents the future of SCS therapy.” In addition to the U.S.

FDA 52

FDA Food and Drug Administration Recruitment Pharmacology 52

European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau. 2023 AD/PD Conference.

Food and Drug Administration 75

Food and Drug Administration Safety Patients Leads 75