The U.S. Food and Drug Administration approved Trevena’s Olinvyk as a new intravenous opioid for short-term management of acute pain in a hospital setting.
Eli Lilly priced the company’s acute migraine treatment Reyvow at $640 for a pack of eight pills.
SK Biopharmaceuticals and U.S. subsidiary SK Life Science announced that the U.S. Food and Drug Administration approved Xcopri (cenobamate tablets) for partial-onset seizures in adults.
A U.S. government watchdog harshly criticized the Drug Enforcement Agency’s response to the opioid crisis, saying amid a surge in opioid-related deaths the agency failed to use the DEA’s most powerful deterrent and authorized an increase in pain pill output.
Lawmakers on the U.S. Senate Judiciary Committee urged the Trump administration to conduct a scientific review of a Justice Department-backed bill to classify all illicit chemical knockoffs of the potent painkiller fentanyl in the same legal category as heroin.
U.S.-listed shares of GW Pharmaceuticals rose 8 percent as the company’s marijuana-based treatment Epidiolex cleared the last hurdle after the Drug Enforcement Administration labeled the drug as having a low abuse potential.
The U.S. Drug Enforcement Agency is readdressing cannabis following the regulatory approval of the first cannabinoid-based drug for the treatment of some epilepsy patients.
Zogenix Inc.’s drug to treat a rare form of childhood epilepsy reduced convulsive seizures in a second late-stage trial, sending the drug developer’s shares up as much as 26 percent.
The Trump administration named a top White House lawyer as the new head of the U.S. Drug Enforcement Administration after the agency’s prior acting administrator announced his retirement in June 2018.
GW Pharmaceuticals Plc’s epilepsy treatment Epidiolex secured FDA marketing clearance, becoming the first cannabis-based drug to be approved in the United States.