2 days ago
FDA Tells Drugmaker ‘Heavy Workload' to Delay Approval Decision
US regulators delayed their decision on whether to approve the first pill taken on demand for a rare, inherited swelling disorder due to a 'heavy workload and limited resources,' a biotech company said.
The US Food and Drug Administration told KalVista Pharmaceuticals Inc. that it won't meet a June 17 deadline to take action on sebetralstat, the company said in a statement. The agency didn't request additional studies or raise concerns about the drug for hereditary angioedema, a condition that causes painful and potentially life-threatening swelling episodes in different parts of the body, it said.
