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Merck & Co has voluntarily withdrawn its Keytruda immunotherapy from a lung cancer niche in the US, amid a crackdown by the FDA on drugs approved without the required post-marketing data. Merck & Co said it had withdrawn the indication after consultation with the FDA and is working to complete the process over the coming weeks.
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.
European Pharmaceutical Review
JUNE 18, 2024
The US Food and Drug Administration (FDA) has approved the first anti-PD-1 therapy in combination with chemotherapy for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status.
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.
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.”.
pharmaphorum
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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