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.

Food and Drug Administration 52

Food and Drug Administration FDA Pharmacology Food 52

Pharmaceutical Technology

MAY 11, 2023

Rexulti has become the first and only pharmacological treatment to receive approval for this indication in the US. The regulator accepted and gr anted priority review for the sNDA in January 2023. We look forward to offering this first FDA-approved treatment option to address this significant unmet need for patients.”

Food and Drug Administration 59

Food and Drug Administration FDA Pharmacology Safety 59

European Pharmaceutical Review

JULY 13, 2023

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). Available from: [link] [Last Accessed: 31st May 2023] Olsson F, Erridge S, Tait J, et al. Expert Review of Clinical Pharmacology. 2023 Mar 4;16(3):257-66. 2023 Dec;24(1):1-5.

Medical 89

Medical Food and Drug Administration Pharmacology Medicine 89

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. See Full Press Release at the Source: Nevro Announces FDA Approval of HFX iQ Spinal Cord Stimulation System to Personalize the Treatment of Chronic Pain. this quarter, with a broad U.S.

FDA 52

FDA Food and Drug Administration Recruitment Pharmacology 52

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. In this exclusive webinar, Dr. Ben Locwin will discuss the potential effects of this draft, along with the pharmacological and toxicological considerations for optimizing doses of prescription drugs. What will the future hold for clinical research?

FDA

pharmaphorum

SEPTEMBER 26, 2022

Astellas has won a reprieve in its attempt to stop Pfizer’s generic medicines unit Hospira launching a copycat version of its pharmacologic stress agent Lexiscan in the US – but only for a couple of weeks. AmphaStar and Glenmark Pharma also claimed FDA approval for versions of the drug earlier this year.

Pharmacology 52

Pharmacology FDA Pharma Marketing 52

European Pharmaceutical Review

APRIL 13, 2023

Psychedelic research: evaluating the fast-evolving regulatory roadmap Psychedelics: the position in Europe The EMA’s recent letter confirms that as of 17 February 2023 in the EU, 6 there were: 11 ongoing clinical trials in EU with psilocybin for a range of central nervous system conditions four ongoing trials with MDMA one trial with LSD.

Medicine 119

Medicine Food and Drug Administration Doctors Government 119