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India’s Growing Importance in Generic Drug API Manufacturing

Drug Patent Watch

Hyderabad’s Pharma City, which has been under construction since 2018, is a significant example of this initiative. Food and Drug Administration (FDA) has been collaborating with the Indian government to promote manufacturing quality and data integrity, supporting the development of harmonized scientific and technical guidelines.

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Gepirone

New Drug Approvals

4] This came after the drug had been rejected by the Food and Drug Administration (FDA) three times over two decades due to insufficient evidence of effectiveness. [5] 4] This came after the drug had been rejected by the Food and Drug Administration (FDA) three times over two decades due to insufficient evidence of effectiveness. [5]

FDA
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Vamorolone

New Drug Approvals

Vamorolone was approved by the FDA in October 2023 for the management of DMD in patients ≥2 years of age. 2018, 38, 320−324. (74) 2018, 38, 320−324. 19] The US Food and Drug Administration (FDA) approved vamorolone based on evidence from a single clinical trial of 121 boys with DMD who were 4 to <7 years of age.

FDA
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Inavolisib

New Drug Approvals

19] Society and culture Legal status In October 2024, the US Food and Drug Administration (FDA) approved inavolisib for the treatment of PIK3CA -mutant breast cancer based on the results from the INAVO120 trial. [3] 3] [6] [20] [21] The drug application was granted priority review and breakthrough therapy designations by the FDA. [3]

FDA
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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). 1] [4] It is taken by mouth. [1]

FDA
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Zilucoplan

New Drug Approvals

April 2018). Food and Drug Administration (FDA). Food and Drug Administration (FDA). World Health Organization (2018). 6] [9] [10] It is a complement inhibitor that is injected subcutaneously (under the skin). [6] 1] Zilucoplan is a 15 amino-acid, synthetic macrocyclic peptide with formula C172H278N24O55. 4 December 2023.

FDA
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Automated red blood cell exchange: bridging treatment gaps in sickle cell disease care

Drug Target Review

Currently, three FDA-approved disease-modifying drug therapies are available: hydroxyurea, crizanlizumab and L-glutamine, though each has limitations that affect patient compliance. Surveillance for Sickle Cell Disease – Sickle Cell Data Collection Program, Two States, 2004-2018. MMWR Surveill Summ. 2022 Oct 7;71(9):1-18.