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FDA approves new Bristol-Myers treatment for multiple myeloma

The U.S. Food and Drug Administration said on Monday it had approved a drug to be sold by Bristol-Myers Squibb Co as a treatment for a form of blood cancer. The FDA said it approved the treatment, Empliciti, to be used in multiple myeloma patients in combination with Celgene Corp’s Revlimid and common anti-inflammatory drug […]

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FDA declines expanded approval for Bristol-Myers’ Opdivo drug

Bristol-Myers Squibb Co said the U.S. Food and Drug Administration declined to approve its immuno-oncology drug, Opdivo, for its expanded use to treat an additional type of advanced skin cancer. Bristol-Myers said it received a so-called complete response letter from the health regulator, which indicated the need for additional data in the BRAF mutated patient […]

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EU approves Roche’s Cotellic in combo therapy against skin cancer

The European Union gave its green light to Roche’s Cotellic for use in combination with the drug Zelboraf against advanced melanoma, the company said on Wednesday.   Roche is counting on Cotellic to help it revive flagging sales of five-year-old Zelboraf, which dropped 25 percent during the first nine months of 2015. It has been […]

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FDA approves expanded use of Bristol-Myers’ skin cancer drug

Bristol-Myers Squibb Co said the U.S. Food and Drug Administration had approved the expanded use of its cancer drug, Opdivo, to treat an additional form of advanced skin cancer. Opdivo, first approved in December 2014, raked in worldwide revenue of $467 million in the nine months ended Sept. 30. The drug has been approved for […]

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Roche buoyed by early data on atezolizumab in advanced melanoma

Swiss drugmaker Roche released on Monday what it called encouraging early data on cancer drug atezolizumab in combination therapy for treating a form of advanced melanoma.   A phase Ib study of atezolizumab (MPDL3280A), used in combination with the BRAF inhibitor Zelboraf for previously untreated BRAFV600 mutation-positive inoperable or metastatic melanoma, showed adverse events were […]

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