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Sage Wins FDA Approval for ‘Game-Changing’ Postpartum Depression Treatment

Sage Therapeutics shares were up after the company won approval for the postpartum depression treatment Zulresso (brexanalone).

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Novo Nordisk submits diabetes pill for U.S. approval

Novo Nordisk submitted the company’s oral semaglutide drug, a pill that management hopes will transform the diabetes market, for approval in the United States.

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FDA approves Roche’s small cell lung cancer treatment

Swiss drugmaker Roche Holding AG’s U.S. unit Genentech Inc. won approval for the immunotherapy Tecentriq for a tough-to-treat type of lung cancer.

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FDA puts partial clinical study hold on Venclexta

The U.S. Food and Drug Administration placed a partial clinical hold on all trials of AbbVie’s Venclexta for multiple myeloma, after a review of data found a higher proportion of deaths in the cancer drug arm of the late-stage study.

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Eton Pharmaceuticals Submits NDA for DS-200

Eton Pharmaceuticals Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for the injectable hospital-use product candidate DS-200 via the Rolling Review process.

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FDA approves generic valsartan amid drug shortage

The FDA – looking to ease shortages triggered by several manufacturers recalling the blood pressure medicine valsartan over possible cancer risk – approved a new generic version of the drug.

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National Cancer Institute chief to serve as acting FDA head

U.S. President Donald Trump’s administration tapped National Cancer Institute Director Norman Sharpless to serve as acting commissioner for the Food and Drug Administration.

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FDA approves Pfizer’s biosimilar to Roche’s Herceptin

The U.S. Food and Drug Administration approved Pfizer Inc.’s biosimilar to Roche AG’s blockbuster breast cancer treatment Herceptin.

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Regeneron/Sanofi wins U.S. approval for expanded use of skin drug

The U.S. Food and Drug Administration approved expanded use of Regeneron Pharmaceuticals Inc. and Sanofi SA’s eczema drug Dupixent to include patients aged between 12 and 17 years.

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Integra gets FDA warning letter for Boston plant

Integra Lifesciences Holdings Corp. received a warning letter from the U.S. Food and Drug Administration regarding the medical device maker ‘s manufacturing facility in Boston.

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