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Tofersen

New Drug Approvals

3] Tofersen was approved for medical use in the United States in April 2023, [3] [6] and in the European Union in May 2024. [4] 4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [7] Food and Drug Administration (FDA). January 2022). 25 April 2023. Retrieved 10 June 2023.

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Inavolisib

New Drug Approvals

3] Inavolisib was approved for medical use in the United States in October 2024. [3] 3] Inavolisib was approved for medical use in the United States in October 2024. [3] 2022 Dec 22;65(24):16589-16621. Epub 2022 Dec 1. Food and Drug Administration (FDA). December 2022). J Med Chem. doi: 10.1021/acs.jmedchem.2c01422.

FDA
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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]. 79 (2022) 1005–1014. [71] 79 (2022)1005–1014 Bioorg. Shale, U.J.

FDA
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Pirtobrutinib

New Drug Approvals

Food and Drug Administration (FDA). FDA Approves Jaypirca (pirtobrutinib), the First and Only Non-Covalent (Reversible) BTK Inhibitor, for Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma After at Least Two Lines of Systemic Therapy, Including a BTK Inhibitor” (Press release). eCollection 2022.

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Elacestrant 

New Drug Approvals

2] The FDA granted the application for elacestrant priority review and fast track designations. [2] Jump up to: a b c d e f g “FDA approves elacestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer” U.S. Food and Drug Administration (FDA). 8 February 2023. 27 January 2023.

FDA
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Sebetralstat

New Drug Approvals

. ^ “KalVista Pharmaceuticals Announces FDA Approval of Ekterly (sebetralstat), First and Only Oral On-demand Treatment for Hereditary Angioedema” (Press release). October 2022). PMID 36251573. ^ “Sebetralstat Orphan Drug Designations and Approvals” U.S. Food and Drug Administration (FDA).

FDA
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Crinecerfont

New Drug Approvals

2] Crinecerfont was approved for medical use in the United States in December 2024. [2] 2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 2] The FDA granted the approval of Crenessity to Neurocrine Biosciences, Inc. [2] Food and Drug Administration (FDA) (Press release).

FDA