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Breakthrough drug candidates and cancer treatment innovations

Drug Target Review

It also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious. It also supports the argument for developing ZW171 for the treatment of other MLSN-expressing solid tumours.

Treatment 100
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FDA Approves First COVID-19 Treatment for Young Children

The Pharma Data

This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the emergency use authorization for Veklury that previously covered this pediatric population. director of the FDA’s Center for Drug Evaluation and Research.

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Metabolism of 2023 FDA Approved Small Molecules – PART 2

Metabolite Tales Blog

It is approved for treatment of severe alopecia areata in which inflammatory processes play a major role, with associated increased reactive oxygen species formation and reduced levels of GSH. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet.

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Metabolism of 2022 FDA approved small molecule drugs PART 2

Metabolite Tales Blog

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Dermavant’s tapinarof is one such friend. 8 This is not the only point of interest.

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Metabolism of 2023 FDA Approved Small Molecules – PART 1

Metabolite Tales Blog

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]. Veozah (Fezolinetant): A Promising Non-Hormonal Treatment for Vasomotor Symptoms in Menopause.

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FDA APPROVES RIABNI™ (RITUXIMAB-ARRX), A BIOSIMILAR TO RITUXAN® (RITUXIMAB), FOR ADULTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS?

The Pharma Data

New Indication for Amgen’s Fifth FDA-approved Biosimilar. Now Approved to Treat All Available Rituxan ® Indications. Overall, 311 patients were randomized and treated with RIABNI, rituximab RP approved in the EU (rituximab-EU) or rituximab RP approved in the US (rituximab-US).

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FDA Approvals Roundup: Kloxxado, Farxiga, Ferriprox

The Pharma Data

It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . The approval was based on results in a prespecified interim analysis of the first 264 patients of the ongoing KEYNOTE-811 trial. New indications.