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Tofersen

New Drug Approvals

Jump up to: a b c d e f g h i j k l “FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene” (Press release). Food and Drug Administration (FDA). Jump up to: a b New Drug Therapy Approvals 2023 (PDF). Food and Drug Administration (FDA) (Report). January 2024.

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Gepirone

New Drug Approvals

However, in 2012 it once again failed to convince the FDA of its qualities for treating anxiety and depression. [5] 5] In December 2015, the FDA once again gave gepirone a negative review for depression due to concerns of efficacy. [12] 12] However, in March 2016, the FDA reversed its decision and gave gepirone ER a positive review. [13]

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Roche announces FDA approval of FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test

The Pharma Data

The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies. A negative result does not rule out the presence of an alteration.

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Medicare program spent $1.8 billion in 2019 on drugs without confirmed clinical benefits

The Pharma Data

billion in Medicare funds in 2019 on drugs whose clinical benefits have yet to be confirmed by the Food and Drug Administration, a new study led by researchers from the Johns Hopkins Bloomberg School of Public Health suggests. billion on 36 of these drugs across 55 indications in 2019. federal government spent an estimated $1.8

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Metabolism of 2022 FDA approved small molecule drugs PART 1

Metabolite Tales Blog

Metabolism of 2022 FDA approved small molecule drugs – Part 1 Does CYP3A4 still rule? By Julia Shanu-Wilson It won’t come as much surprise to learn that of the 17 small molecules* approved by the FDA in 2022, CYP3A4 was the major player in drug metabolism. 2019), although many of these are very minor.

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FDA Approves Pfizer Med for Rare Form of Pediatric Non-Hodgkin Lymphoma

The Pharma Data

Food and Drug Administration (FDA) approved Pfizer ’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. Manuel Esteban/Shutterstock.

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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. We hope it was a useful two-parter! We’re looking forward to the next crop! 6] Grillo et al.,