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Terlipressin products are authorized in several EU countries to treat increased pressure in central veins that can cause kidney problems in people with hepatorenal syndrome. Read More
The FDA has issued a warning about the potential for serious dental problems associated with buprenorphine medicines dissolved in the mouth to treat opioid use disorder (OUD) and pain. Read More
The FDA has put a clinical hold on Gilead Sciences’ injectable HIV drug lenacapavir because of the risk of glass particles from the vials getting into the medication. Read More
Gilead Sciences has recalled two lots of its blockbuster COVID-19 antiviral Veklury (remdesivir) for possible contamination with glass particulates. Read More
The problem lots were made in India and shipped to one distributor in the U.S. that "may have” further released the product nationwide, the FDA said. Read More
A trial pitting Washington state against the three largest U.S. drug distributors began yesterday, with the state seeking more than $38 billion in damages from the companies for their alleged role in fueling the opioid epidemic within its borders. Read More
A federal judge in Pennsylvania is allowing a trial to proceed against Merck alleging the company’s Zostavax shingles vaccine induced the disease instead of preventing it. Read More
J&J confirmed to FDAnews that “rare cases of transverse myelitis” have been reported following vaccination and pledged to cooperate with health agencies. Read More