Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. link] [3] FDA prescribing information for daprodustat. Pharmacokinetics and Metabolism of Nirmatrelvir.

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Small Molecule FDA Approval FDA Pharmacokinetics 52

The Pharma Data

AUGUST 30, 2021

In 2016, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Dupixent for the treatment of severe atopic dermatitis (in children aged 6 months to 11 years of age). Detailed results from this trial will be presented at a future medical meeting, and data will be submitted to regulatory authorities.

Trials 52

Trials Disease Treatment Clinical Trials 52

The Pharma Data

DECEMBER 15, 2020

Under the terms of the amended agreement , originally executed in 2016 with Bristol Myers’ Celgene, an undisclosed fee was paid to Anokion to include KAN-101 for the treatment of celiac disease in the exclusive global collaboration. The secondary outcome involves pharmacokinetic endpoints. Receptor Inhibitors.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

FDA Law Blog: Biosimilars

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

Regulations 69

Regulations FDA Treatment Drugs 69

Agency IQ

SEPTEMBER 15, 2023

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. The committee also made recommendations regarding pharmacokinetic and safety assessments.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

JUNE 28, 2021

There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. From November 2016 to June 2019, a total of 112 participants were enrolled across 36 sites in 10 countries. UNIVERSE was conducted in two parts.

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FDA Clinical Trials Treatment Therapies 52