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U.S. Sen. Joe Manchin (D-W.Va.) says he will call for a Senate investigation into the FDA’s decision to allow OxyContin to be prescribed to children as young as 11. Read More
Seattle Genetics has received FDA approval for its cancer drug Adcetris to treat patients with Hodgkin lymphoma who are at high risk of relapse following an autologous haematopoietic stem cell transplant to help curb the disease’s progression. Read More
The Federal Trade Commission has reached a settlement with Par Pharmaceuticals and Concordia Pharmaceuticals that, if finalized, would prohibit them from restraining trade in the sale of generic Kapvay, an attention deficit hyperactivity disorder drug. Read More
HHS has contracted with San Diego-based Pfenex Pharmaceuticals to develop an anthrax vaccine that is effective after exposure — under an agreement valued at up to $143 million. Read More
The FDA has granted orphan drug designation to La Jolla Pharmaceutical for two novel compounds to treat fibrodysplasia ossificans progressiva, a genetic mutation that turns muscle into bone. Read More
Long Beach, Calif.-based Hartley Medical is voluntarily recalling three lots of its Prolotherapy with Phenol injectable because of nonsterility concerns, as drug compounding pharmacies continue to struggle to get their sterile processing systems under control. Read More
Actavis must remove its generic version of Endo’s noncrush-resistant painkiller Opana from the U.S. market by Oct. 13, a New York federal judge ruled Friday, citing infringement of Opana’s patents. Read More
Spectrum Pharmaceuticals is on track to file an NDA for its cancer drug apaziquone by the end of this year, following agreement with the FDA on a special protocol assessment for a Phase 3 clinical trial in patients with non-muscle invasive bladder cancer. Read More
Vaccines makers should submit individual case safety reports and attachments to the Vaccine Adverse Event Reporting System using either the direct database-to-database method or the eSubmitter tool method, the FDA says. Read More
The primary efficacy endpoint in clinical trials for uncomplicated gonorrhea should be a negative culture at the infection site three to seven days after receiving antibacterial drug therapy, the FDA says. Read More