Merck & Co.
213 E Grand Avenue, South San Francisco, CA
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320 Bent St, Cambridge, MA 02141
United States
4224 articles about Merck & Co.
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FDA Approves KEYTRUDA® (pembrolizumab) for Treatment of Patients With Resectable (T≥4 cm or N+) NSCLC in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as a Single Agent as Adjuvant Treatment After Surgery
10/16/2023
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of patients with resectable (tumors ≥4 centimeters [cm] or node positive) non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
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The FDA is gearing up for six decisions in the next two weeks, two of which involve highly anticipated medicines for rare diseases.
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Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Chemotherapy as First-Line Treatment for HER2-Negative Advanced Gastric or Gastroesophageal Junction (GEJ) AdenocarcinomaExpressing PD-L1 (CPS ≥1)
10/13/2023
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA.
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Merck Highlights Innovative Oncology Portfolio and Pipeline at ESMO Congress 2023 Underscoring Commitment to Advancing Cancer Research and Improving Patient Outcomes Across Multiple Stages of Disease
10/10/2023
Merck, known as MSD outside of the United States and Canada, announced that new data for four approved medicines and three pipeline candidates in more than 15 types of cancer will be presented at the European Society for Medical Oncology Congress 2023 in Madrid, Spain, from Oct. 20-24.
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Merck Announces Pivotal KEYNOTE-671 Trial Meets Dual Primary Endpoint of Overall Survival (OS) in Resectable Stage II, IIIA or IIIB Non-Small Cell Lung Cancer (NSCLC)
10/10/2023
Merck, known as MSD outside of the United States and Canada, announced the Phase 3 KEYNOTE-671 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as a perioperative treatment regimen for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer met its dual primary endpoint of overall survival.
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The pharma giant’s anti-PD-1 therapy met its dual primary endpoint of overall survival as a treatment regimen for non-small cell lung cancer patients, as the FDA’s Oct. 16 PDUFA date looms.
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Keytruda’s winning streak in bladder continues with positive data from the Phase III AMBASSADOR study, showing significantly better disease-free survival in muscle-invasive urothelial carcinoma.
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Merck to Hold Third-Quarter 2023 Sales and Earnings Conference Call Oct. 26
10/5/2023
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, will hold its third-quarter 2023 sales and earnings conference call with institutional investors and analysts at 9:00 a.m. ET on Thursday, Oct. 26.
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Merck is Collaborating to Address Antimicrobial Resistance
10/5/2023
Antibiotics have transformed health care and saved countless lives. But rising levels of antimicrobial resistance (AMR) can make current antibiotics less effective.
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Merck’s KEYTRUDA® (pembrolizumab) Met Primary Endpoint of Disease-Free Survival (DFS) in Certain Patients With Muscle-Invasive Urothelial Carcinoma (MIUC) After Surgery
10/5/2023
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 AMBASSADOR (A031501) trial (KEYNOTE-123) evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, met one of its dual primary endpoints of disease-free survival (DFS) for the adjuvant treatment of patients with localized muscle-invasive urothelial carcinoma (MIUC) and locally advanced urothelial carcinoma versus observation.
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Ankyra Therapeutics Announces Clinical Trial Collaboration and Supply Agreement with Merck to Evaluate ANK-101 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Advanced Solid Tumors
10/4/2023
Ankyra Therapeutics Announces Clinical Trial Collaboration and Supply Agreement with Merck to Evaluate ANK-101 in Combination with KEYTRUDA ® (pembrolizumab) in Patients with Advanced Solid Tumors.
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Despite lawsuits by some companies challenging the negotiations under the Inflation Reduction Act, the manufacturers of the first 10 drugs selected for Medicare price talks will participate in the program.
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AbbVie, Amgen, Gilead, Merck and Novartis are among the 31 members that have formed the Partnership for the U.S. Life Science Ecosystem to push back against federal antitrust reforms.
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Merck Helps To Improve Diversity in Clinical Trials Through Beacon of Hope
10/3/2023
Increasing diversity in clinical trials plays a crucial role in helping to understand how a broad range of human bodies may respond to treatments.
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Merck Receives Priority Review from FDA for New Biologics License Application for Sotatercept, an Activin Signaling Inhibitor to Treat Adults with Pulmonary Arterial Hypertension (PAH)
9/28/2023
Merck, known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug Administration has accepted for priority review a new Biologics License Application for sotatercept, Merck’s novel investigational activin signaling inhibitor, for the treatment of adult patients with pulmonary arterial hypertension .
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The losing streak continues for Merck and Eisai with their Keytruda-Lenvima combination failing to improve progression-free survival and overall survival in two late-stage lung cancer studies.
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Merck and Eisai Provide Update on Two Phase 3 Trials Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Patients With Certain Types of Metastatic Non-Small Cell Lung Cancer
9/22/2023
Merck, known as MSD outside of the United States and Canada, and Eisai provided updates on two Phase 3 trials, LEAP-006 and LEAP-008, evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, in patients with certain types of metastatic non-small cell lung cancer.
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Merck Announces Phase 3 KEYNOTE-A39/EV-302 Trial Met Dual Primary Endpoints of Overall Survival (OS) and Progression-Free Survival (PFS) in Certain Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
9/22/2023
Merck, known as MSD outside of the United States and Canada, announced positive topline results from the Phase 3 KEYNOTE-A39 trial, which was conducted in collaboration with Seagen and Astellas, evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma.
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The companies, which are collaborating on a drug combination to treat locally advanced and metastatic urothelial cancer, announced Friday that their Phase III trial met dual primary endpoints.
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ARS Pharmaceuticals, Intarcia Therapeutics and Taysha Gene Therapies this week got stark reminders of the difficulties in getting treatments through the regulator’s approval process.