Government
Frank Reynolds, the founder and chief executive officer of PixarBio, was also ordered to repay $7.5 million to investors who backed the company’s non-opioid painkiller, NeuroRelease.
It doesn’t happen that often, but Merck’s checkpoint inhibitor Keytruda received a rejection from the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration issued a statement on Friday outlining what the agency is doing at home and abroad in response to the outbreak, which has infected more than 73,000 people worldwide.
The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion is interested in how social media affects the public’s perception of drugs.
The U.S. Food and Drug Administration accepted the companies’ New Drug Application for lurbinectedin under Priority Review.
The U.S. Food and Drug Administration has a busy week planned for drug review. Here’s a look at this week’s schedule.
Now that global responses are fully mobilized, what is being done to identify and develop drugs and vaccines against this novel coronavirus?
Eisai indicated it was voluntarily withdrawing the drug, but in a statement noted it disagreed with the FDA’s interpretation of the data and believes the drug’s benefits outweigh the cancer risk.
The therapy was also granted Rare Pediatric Disease designation for neuronopathic Gaucher disease, the most severe form of the condition.
Steve Hoerter, president and chief executive officer of Deciphera, said the acceptance of the NDA brings the company one step closer to its goal of providing a new treatment option for patients with advanced GIST.
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