Remove Clinical Pharmacology Remove FDA Approval Remove Trials
article thumbnail

Vamorolone

New Drug Approvals

Syn EuropeanJournalofMedicinalChemistry265(2024)116124 Vamorolone (Agamree) On October 26, 2023, Vamorolone, developed jointly by Santhera Pharmaceuticals and ReveraGen BioPharma, has received FDA approval to treat DMD in patients aged 2 years and older [1]. Shale, U.J. 79 (2022) 1005–1014. [71] Reeves, E.P. Hoffman, K. Nagaraju, J.M.

FDA 62
article thumbnail

Landiolol

New Drug Approvals

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 Randomized clinical trials have been published to compare landiolol with placebo< [21] [22] [23] diltiazem, [24] and amiodaron [25] in patients with or without heart failure.

FDA 62
Insiders

Sign Up for our Newsletter

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

article thumbnail

Webinar: Assessing Cognition Impairment Using Driving Simulators in Clinical Trials

Alta Sciences

Utilizing 10 state-of-the-art simulators available in-house at our Montréal clinical facility (with the capacity for more than 20), we are equipped to measure a range of studies; from impairment in cognition and comparing compounds to assessing the impact on new formulations have on impairment. Tags Clinical Trials Weight 12

article thumbnail

Eplontersen

New Drug Approvals

2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. Food and Drug Administration (FDA).

article thumbnail

Metabolism of macrocyclic drugs

Metabolite Tales Blog

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.

Drugs 52
article thumbnail

Metabolism of de novo designed macrocyclic drugs

Metabolite Tales Blog

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.

Drugs 52
article thumbnail

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. Finally, the committee came up with a list of recommendations for the structure of additional trials, listed in the meeting minutes.

Science 40