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News Breaks
February 28, 2014
08:34 EDTMRKMerck's NOXAFIL gets positive opinion from CHMP
Merck announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of a new, investigational tablet formulation of NOXAFIL. The CHMP positive opinion will be reviewed by the European Commission, which if approved, grants a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members Iceland, Liechtenstein and Norway.
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July 27, 2015
15:03 EDTMRKNotable companies reporting before tomorrow's open
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14:43 EDTMRKEarnings Watch: Merck's Keytruda sales will be focus in Q2 results
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08:32 EDTMRKMerck receives 'positive' CHMP opinion for Zerbaxa
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07:37 EDTMRKAeterna Zentaris starts promoting Saizen for injection in 25 U.S. territories
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July 23, 2015
11:04 EDTMRKMerck announces EMA acceptance of MAA for grazoprevir/elbasvir
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July 22, 2015
07:04 EDTMRKMerck's Keytruda approved by EU for treatment of advanced melanoma in adults
Merck announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of advanced melanoma in adults. The European Commission approval of pembrolizumab is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. Pembrolizumab received European Commission regulatory approval based on Phase 3 data which showed it is the first and only anti-PD-1 therapy to provide a statistically superior survival benefit as a monotherapy compared to ipilimumab, the current standard of care for advanced melanoma. Today’s approval allows marketing of pembrolizumab in all 28 EU member states at the approved dose of 2 mg/kg every three weeks. The European Commission’s approval is based on data from three studies -- KEYNOTE-001, KEYNOTE-002 and KEYNOTE-006. These studies evaluated the efficacy and safety of pembrolizumab in advanced melanoma patients – across treatment lines, prognostic factors, tumor characteristics, and BRAF mutational status – and established 2 mg/kg every three weeks as the approved dose.
06:05 EDTMRKMerck, Ablynx expand immuno-oncology collaboration
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