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CDER released its fourth annual Drug Trials Snapshots report, which shows a significant drop in the number of participants in pivotal novel drug trials that led to agency approvals. Read More
The approval will “bring more competition to the market which will ultimately benefit the patients who rely on this drug,” said CDER Director Janet Woodcock. Read More
Metastatic melanoma, also known as Stage IV melanoma, can spread to other parts of the body, with the liver, lungs, bones and brain most susceptible. Read More
The addition of Perjeta, in combination with the current first-line treatment, significantly increased progression-free and overall survival. Read More