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

Written by | 28 Dec 2023

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… read more.

Keytruda (pembrolizumab) met a primary endpoint of disease-free survival in certain patients with muscle-invasive urothelial carcinoma after surgery – Merck Inc

Written by | 16 Oct 2023

Merck Inc., known as MSD outside of the United States and Canada, announced that the Phase III AMBASSADOR (A031501) trial (KEYNOTE-123) evaluating Keytruda, Merck’s anti-PD-1 therapy, met one… read more.

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

Written by | 25 Sep 2023

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… read more.

Long-term follow-up data on sustained immunogenicity and safety for Gardasil 9 published in Pediatrics – Merck Inc

Written by | 12 Sep 2023

Merck Inc., known as MSD outside of the United States and Canada, announced new, 10-year long-term follow-up (LTFU) data published in the peer reviewed journal, Pediatrics, for girls… read more.

FDA approves expanded indication for Ervebo in Zaire ebolavirus – Merck Inc

Written by | 11 Aug 2023

Merck Inc announced that the FDA has approved an expanded indication for Ervebo, which is now indicated for the prevention of disease caused by Zaire ebolavirus in individuals… read more.

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

Written by | 25 Jul 2023

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)… read more.

Lynparza + abiraterone approved in the US for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer – AstraZeneca + Merck Inc

Written by | 31 May 2023

AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the US for the treatment of adult patients with deleterious or… read more.

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

Written by | 27 Feb 2022

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… read more.

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

Written by | 5 Feb 2022

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… read more.

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

Written by | 29 Jan 2022

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,… read more.

FDA approves Keytruda plus chemotherapy for cervical cancer – Merck

Written by | 22 Jan 2022

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… read more.

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

Written by | 6 Oct 2021

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… read more.

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