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The FDA has granted part of a citizen petition calling for a safety warning on certain dopamine agonist drugs on the risks of impulse-control disorders (ICD)s for patients taking the drugs for restless legs syndrome (RLS). Read More
The FDA outlined the manufacturing facility information that should be included in applications submitted to CDER and CBER in a final guidance released on Tuesday. Read More
On a party-line vote of 24 to 17, the House Committee on Ways and Means on Tuesday advanced House Speaker Nancy Pelosi’s drug pricing legislation, H.R. 3, to the house floor. Read More
For the updated report, ICER considered that when the line-one treatment fails, patients are transitioned to “a market basket of targeted immune modulators,” as opposed to palliative care. Read More
“Rapid rollout of better-tolerated treatment containing bedaquiline will happen only if J&J makes it widely available in an affordable way,” MSF said. Read More
“We know that the migraine community is keenly interested in additional treatment options,” said Nick Kozauer, acting deputy director of CDER’s Division of Neurology Products. Read More
In its latest cost-benefit analysis, the Institute for Clinical and Economic Review (ICER) found that Janssen’s Xarelto (rivaroxaban) and Amarin Pharma’s Vascepa (icosapent ethyl) are cost-effective treatments for cardiovascular disease — provided not all eligible patients are treated. Read More
In a letter to acting FDA Commissioner Ned Sharpless, three U.S. lawmakers demanded updates on Takeda Pharmaceuticals’ recall of Natpara (parathyroid hormone), an injection used to treat a rare parathyroid disorder. Read More
In a 3:00 p.m. EST teleconference on Monday, the attorneys general of Pennsylvania, North Carolina, and Tennessee confirmed they had reached a $48 billion settlement for thousands of opioid lawsuits with drugmakers Teva and Johnson & Johnson, as well as distributors McKesson, Cardinal Health and AmerisourceBergen. Read More