pharmaphorum

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Merck & Co has voluntarily withdrawn its Keytruda immunotherapy from a lung cancer niche in the US, amid a crackdown by the FDA on drugs approved without the required post-marketing data. Merck & Co said it had withdrawn the indication after consultation with the FDA and is working to complete the process over the coming weeks.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

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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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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The FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). Under the Administrative Procedure Act, FDA is obligated to address major substantive issues when – and not so much if – it publishes a final rule.

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European Pharmaceutical Review

NOVEMBER 4, 2022

These are identical to doses used in human trials for FDA approval. Co-principal investigator on the study, Dr Jeffrey Petrella, Professor of Radiology and Director of the Alzheimer Imaging Research Laboratory at Duke University added: “It often takes tens of millions of dollars and many years to do a head-to-head comparison of drugs.”.

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European Pharmaceutical Review

AUGUST 12, 2024

Progress in immunotherapy drug development In June, the US Food and Drug Administration (FDA) authorised an immunotherapy combination to treat endometrial cancer. The bispecific antibody has shown potential to generate “significant and sustained reductions in B-cell populations”. The deal is anticipated to be finalised in Q3 of 2024.

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pharmaphorum

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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