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Gepirone

New Drug Approvals

The FDA rejected approval for gepirone in 2002 and 2004. [5] 5] It was submitted for the preregistration (NDA) phase again in May 2007 after adding additional information from clinical trials as the FDA required in 2009. 12] However, in March 2016, the FDA reversed its decision and gave gepirone ER a positive review. [13]

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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.

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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]. 2015 Apr;35(3):377-387. 26 October 2023. Retrieved 27 October 2023.

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A Visual Guide to Genome Editors

Codon

The treatment, now known as Casgevy, became the first CRISPR-based therapy to gain FDA approval, in 2023. Cas12 Discovery Cas12 was initially characterized in 2015 by Feng Zhang’s lab at the Broad Institute 5 and was quickly adopted as a complementary genome editor to Cas9.

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Landiolol

New Drug Approvals

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 FDA Approves AOP Health’s Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting” (Press release). March 2015). AOP Health.

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FDA approves GlaxoSmithKline’s Nucala to treat hypereosinophilic syndrome

The Pharma Data

Today’s approval gives these patients access to biologic treatment for the first time and demonstrates our commitment to maximising Nucala’s impact on eosinophil-driven diseases. “. It also received approval in 2019 to treat severe eosinophilic asthma in children. .

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Nevakar Announces FDA Approval for Ephedrine Sulfate Injection as Ready-to-Use Vials

The Pharma Data

This is the first approval under the previously announced collaboration between Nevakar and Endo for the development of five differentiated, sterile injectable products in the U.S. and Canada. About Nevakar Inc. Nevakar Inc.