The FDA has told MEI Pharma and Kyowa Kirin that they will need to provide more than results from a single-arm phase 2 study on their oral lymphoma drug candidate…
The U.S. government is pulling GlaxoSmithKline’s and Vir Technology’s investigational monoclonal antibody for COVID-19 from certain states where cases of the new subvariant of Omicron, BA.2, are high, as tests…
The European Medicines Agency’s (EMA) human medicines committee endorsed five new medicines — including a COVID-19 treatment and a gene therapy — during its monthly meeting held from March 21…
After 14 years of legal wrangling over Fosamax’s bone-fracture risk, Merck has managed to get a federal judge to dismiss in excess of 500 lawsuits charging the drugmaker with staying…
Novo Nordisk has settled a patent dispute with Novartis over allegations that the Swiss company infringed on patents for Victoza (liraglutide), Novo Nordisk’s blockbuster type 2 diabetes drug. Source: Drug…
Takeda Pharmaceuticals has received a Complete Response Letter from the FDA denying its Prior Approval Supplement (PAS) application for Natpara (parathyroid hormone) for chronic hypoparathyroidism. Source: Drug Industry Daily
Just hours before it was to face the start of a trial, Sun Pharmaceuticals of India said it will pay $485 million to settle years-old lawsuits alleging its Ranbaxy Pharmaceuticals…
A coalition of advocacy groups has appealed to Health and Human Services Secretary Xavier Becerra to act unilaterally to lower the prices of six prescription drugs using an obscure and…
Because its phase 3 trial was conducted only in China, the FDA has told Eli Lilly to go back to the drawing board with its promising investigational checkpoint inhibitor sintilimab…
The FDA has issued a warning letter to Monroe Township, N.J.-based Premier Trends for online marketing of a misbranded and adulterated drug called Magic Heal, an over-the-counter blend of essential…