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The FDA published draft revisions to its blueprint for educating health care providers about extended-release and long-acting opioid painkillers. Read More
The FDA issued warnings to Indian API manufacturer Vikshara Trading and Investments over serious violations, including hindering the agency’s investigation, and to Huron Pharmaceuticals, citing quality documentation issues. Read More
Biosimilars consistently drive down average drug prices in markets where they are introduced, according to a report ordered by the European Commission. Read More
In a Tuesday meeting, the FDA’s Science Board reviewed and largely supported the agency’s proposed plan for implementing the 21st Century Cures Act over the next nine years. Read More
Merck Sharp & Dohme Corp. is settling its challenge over a Genentech patent on methods for artificially synthesizing antibodies, a process used for a variety of specialty medicines and cancer therapies. Read More