Regulatory
Padcev, which was approved by the U.S. Food and Drug Administration in December, secured Breakthrough Therapy designation for the treatment of patients with another type of bladder cancer.
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.
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.
Did the price of a newly-approved treatment for a rare autoimmune disease and pressure from U.S. Sen. Bernie Sanders lead to the approval of a rival treatment? That’s what Florida-based Catalyst Pharmaceutical is attempting to show in court.
Vela Diagnostics Submitting Novel Coronavirus Diagnostic Test to FDA for Emergency Use Authorization
Vela Diagnostics has developed the ViroKeyTM SA201 COVID-19 RT-PCR Test, a new diagnostic test for the detection of the COVID-19 coronavirus. Vela Diagnostics is currently in discussions with the U.S. Food and Drug Administration for clearance of the test under the emergency use authorization.
The therapy was also granted Rare Pediatric Disease designation for neuronopathic Gaucher disease, the most severe form of the condition.
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