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FDA Action Alert: Merck, Agios and AMAG Pharma

June 2019 is a busy month for approval applications for the U.S. Food and Drug Administration as the regulatory agency has a slate of PDUFA dates.

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FDA Approves Bavencio Plus Inlyta Combination for Patients with Advanced Renal Cell Carcinoma

EMD Serono and Pfizer announced that the U.S. FDA approved Bavencio (avelumab) in combination with Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma.

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Keytruda In Combination With Inlyta Reduced Risk Of Death By Nearly Half Compared To Sunitinib As First-Line Treatment For Advanced RCC

Merck & Co. announced presentation of the full results from the pivotal Phase 3 KEYNOTE-426 trial investigating the company’s anti-PD-1 therapy Keytruda in combination with Inlyta, a tyrosine kinase inhibitor, for the first-line treatment of advanced renal cell carcinoma (RCC) at the 2019 Genitourinary Cancers Symposium.

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MedAdNews

Extensive pharmaceutical business and marketing intelligence. For back issues, please contact MDAD@kmpsgroup.com.

June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!

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