Pharmaceutical Technology

JUNE 7, 2023

The US Food and Drug Administration (FDA) has granted approval for a new indication for Merck’s PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients. The latest move follows a priority review of a supplemental new drug application (sNDA) for the therapy.

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Pharmaceutical Technology

JUNE 23, 2022

The US Food and Drug Administration (FDA) has granted approval for Merck's (MSD outside the US and Canada) pneumococcal 15-valent conjugate vaccine, Vaxneuvance, for use in children aged six weeks to 17 years. The post US FDA grants approval for Merck’s pneumococcal vaccine for children appeared first on Pharmaceutical Technology.

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MARCH 2, 2021

Merck & Co has voluntarily withdrawn its Keytruda immunotherapy from a lung cancer niche in the US, amid a crackdown by the FDA on drugs approved without the required post-marketing data. Merck & Co said it had withdrawn the indication after consultation with the FDA and is working to complete the process over the coming weeks.

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Pharmaceutical Technology

APRIL 4, 2023

Merck has secured approval from the US Food and Drug Administration (FDA) for KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) for first-line treatment of some adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). 12% experienced a complete response and 55% a partial response.

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APRIL 9, 2021

Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories said in a statement that the data marked the first time an anti-PD-1 therapy showed potential adjuvant treatment for patients with RCC.

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Pharmaceutical Technology

AUGUST 5, 2022

The US Food and Drug Administration (FDA) approved Lynparza in March for this indication. A PARP inhibitor, Lynparza (olaparib) is said to be the first targeted therapy to hinder DNA damage response in cells/tumours with a deficiency in homologous recombination repair.

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SEPTEMBER 28, 2021

Merck & Co’s FDA approval for Keytruda in advanced liver cancer looks secure, after an Asian clinical trial found that the cancer immunotherapy improved survival in these patients. Keytruda (pembrolizumab) was cleared by the FDA as a second-line therapy for the hepatocellular carcinoma (HCC) form of liver cancer in 2018.

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