Metabolite Tales Blog

JULY 5, 2023

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.

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The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

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Agency IQ

OCTOBER 6, 2023

While stimulant use disorder is increasing, there are currently no FDA-approved medications. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), “between 2008 and 2015, amphetamine-related hospitalizations more than tripled, increasing from 55,447 instances to 206,180.

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National Institute on Drug Abuse: Nora's Blog

FEBRUARY 1, 2024

The Drug Abuse Treatment Act of 2002, for instance, enabled the newly approved medication buprenorphine, developed through NIDA research, to be prescribed by regular physicians if they obtained a waiver. People in rural communities may have particular difficulty accessing care. Most of the fatal overdoses each year involve opioids.

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Science FDA Approval Treatment Research 122

New Drug Approvals

APRIL 5, 2025

7] Treosulfan was authorized for medical use in the European Union in June 2019, [9] and approved for medical use in the United States in January 2025. [7] 7] Treosulfan was authorized for medical use in the European Union in June 2019, [9] and approved for medical use in the United States in January 2025. [7] 57 (10): 12551265.

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Drug Target Review

JANUARY 16, 2025

These sites are commonly involved in protein-protein interactions, some of which are key to disease development. Food and Drug Administration (FDA) approved drugs, macrocycles are used to combat a range of diseases, including cancer, viral, fungal and bacterial infections, neurodegenerative and autoimmune diseases.

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Drug Development Small Molecule Drugs FDA Approval 52

Drug & Device Law

DECEMBER 21, 2023

Shikada is the first appellate decision creating a state-law warning-based duty (here, via a consumer protection claim, brought by the state rather than anyone actually claiming injury) based solely on pharmacogenomics − racially/ethnically-based genetic variations − allegedly affecting the effectiveness of FDA-approved prescription drugs.

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FDA Approval FDA Drugs Production 52

Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications. An unfortunate fiction developed post- Buckman —particularly after Riegel v.

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FDA Regulations FDA Approval Production 59

Drug & Device Law

OCTOBER 10, 2022

The drug at issue was an FDA-recognized breakthrough drug that treats a relatively rare, but invariably fatal, condition – transthyretin amyloid cardiomyopathy (“ATTR-CM”). ATTR-CM is a progressive heart disease that causes protein fibrils to deposit in the left ventricle of the heart, eventually leading to heart failure. 124, 131 n.3

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Drugs FDA Approval FDA Disease 52

Drug & Device Law

MARCH 31, 2022

Medicare covers quite a few off-label uses, because the relevant term – “medically accepted indication” – includes all drug uses, whether or not FDA-approved, that are “supported by one or more citations included or approved for inclusion in any of the [certain medical] compendia.” check; disease-related ? 1396r-8(k)(6).

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