Regulatory
Ireland-based Horizon Pharma reported additional statistically significant secondary data from its positive Phase III study at a conference and plans to continue to share analysis at future medical conferences.
Bausch Health, former known as Valeant Pharmaceuticals International, announced that the U.S. Food and Drug Administration (FDA) had approved its Duobrii (halobetasol propionate and tazoretene) Lotion for plaque psoriasis.
The U.S. Department of Justice (DOJ) is reviewing a government patent for HIV, according to a retired Centers for Disease Control and Prevention (CDC) scientist.
Biom’up announced that the U.S. Food and Drug Administration approved the IDE application for HEMOSNOW, a hemostatic dry powder made from porcine collagen and bovine-derived chondroitin sulfate developed by the Company for managing minimal and mild levels of bleeding during surgical procedures.
Accenture recently published a new report, “New Science: Biopharma’s New Growth Machine.” In it, the report attempts to evaluate the last 20 years of trends in biopharma and use that data to develop projections for the future of the industry.
Companies across Europe and Asia provide information about deal, clinical trials and more, with news from Synaptive Medical, Epic, Inventiva, Velabs, and more.
GenFit’s lead product candidate elafibranor snagged Breakthrough Therapy Designation from the U.S. Food and Drug Administration as a treatment for Primary Biliary Cholangitis (PBC) following strong Phase II results that demonstrated the safety and efficacy of the medication.
Renal cell carcinoma is also called renal cell cancer or renal cell adenocarcinoma. Approximately 90% of all kidney cancers are renal cell carcinomas.
The FDA said the approval of Teva’s product is the first generic naloxone nasal spray for use in a community setting by individuals without medical training.
FDA grants elafibranor Breakthrough Therapy Designation, based on Phase 2 data, for treatment of PBC (Primary Biliary Cholangitis) in adults with inadequate response to UDCA
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