December 28, 2023

Complete Response Letter for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough – Merck

Merck Inc., known as MSD outside of the United States and Canada, announced that the FDA has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application (NDA) for gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults . In the CRL, […]

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September 25, 2023

FDA grants priority review to application for Keytruda + concurrent chemoradiotherapy, as treatment for newly diagnosed high-risk locally advanced cervical cancer – Merck Inc

Merck Inc., known as MSD outside of the United States and Canada, announced the FDA has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda, Merck’s anti-PD-1 therapy, in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment with definitive intent for newly diagnosed […]

admin Health 0 1 min read
July 25, 2023

CHMP recommends Lyfnua as a treatment for refractory or unexplained chronic cough – Merck Inc

Merck Inc., known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of gefapixant, an investigational, non-narcotic, oral selective P2X3 receptor antagonist, developed for the treatment for adults with refractory or unexplained chronic cough. The CHMP’s recommendation will now be […]

admin Health 0 1 min read
February 27, 2022

NICE UK recommends Keytruda with carboplatin and paclitaxel for metastatic squamous non-small-cell lung cancer – Merck Inc

NICE (UK): Keytruda (pembrolizumab), from Merck Inc. with carboplatin and paclitaxel is recommended as an option for untreated metastatic squamous non-small-cell lung cancer (NSCLC) in adults, only if their tumours express PD?L1 with a tumour proportion score of 0% to 49%, if their tumours express PD?L1 with a tumour proportion score of 50% or more and they need urgent clinical […]

admin Health 0 1 min read
February 5, 2022

European Commission approves Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for individuals 18 years of age and older – Merck Inc

Merck Inc., announced that the European Commission (EC) has approved Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. The approval allows marketing of Vaxneuvance in all 27 European Union (EU) Member States plus Iceland, Norway and Lichtenstein. The use of […]

admin Health 0 2 min read
January 29, 2022

European Commission approves Lenvima + Keytruda to treat endometrial carcinoma – Eisai + Merck Inc.

Eisai Co., Ltd. and Merck Inc., announced that the European Commission has approved the combination of Lenvima, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus Keytruda, the anti-PD-1 therapy from Merck Inc., for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy […]

admin Health 0 1 min read
January 22, 2022

FDA approves Keytruda plus chemotherapy for cervical cancer – Merck

Merck Inc., announced that the FDA has approved Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (Combined Positive Score [CPS] at least 1) as determined by an FDA-approved test. The approval is based on the Phase III KEYNOTE-826 trial evaluating Keytruda plus […]

admin Health 0 1 min read
October 6, 2021

Phase III KEYNOTE-394 trial of Keytruda meets primary endpoint in hepatocellular carcinoma – Merck Inc

Merck Inc announced that the Phase III KEYNOTE-394 trial investigating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in Asian patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib met its primary endpoint of overall survival (OS). The study found that treatment with Keytruda plus best supportive care resulted in a statistically significant improvement in OS compared with placebo plus best supportive […]

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August 9, 2021

FDA approves Keytruda to treat high-risk early-stage triple-negative breast cancer – Merck Inc.

Merck Inc. announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery, based on the Phase III KEYNOTE-522 trial. TNBC is an aggressive type of breast cancer with an […]

admin Health 0 1 min read
July 11, 2021

Merck Inc provides update on Keytruda indication in third-line gastric cancer in the US

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admin Health 0 27 sec read

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