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The FDA revoked orphan drug status for Indivior’s overdose-treatment Sublocade in November 2019, admitting that it made a mistake in granting the designation. Read More
In his State of the Union address last night, President Trump called on Congress to pass legislation to curb the nation’s high drug prices, saying he would sign a bipartisan bill into law if it reached the Oval Office. He did not mention insulin pricing as expected. Read More
A U.S. court has ruled in favor of the FDA in a case filed by Vanda Pharmaceuticals alleging the agency didn’t provide an adequate scientific reason for a partial clinical hold issued in December 2018 for the company’s long-term study of tradipitant. Read More
In the wake of declaring the coronavirus a global emergency, the World Health Organization (WHO) has issued a new procedure for drugmakers that wish to submit unapproved drug products for public health crises. Read More
The vendor was charged with receiving $1 million from an unnamed opioid drugmaker to create an alert aimed at pushing doctors to prescribe more extended-release opioids. Read More
Sponsors of biologics and biosimilars should carefully consider how they present safety and efficacy information in their promotional materials, the FDA said in a draft guidance released yesterday. Read More
The European Medicines Agency issued a draft paper to clarify the responsibilities of marketing authorization holders (MAHs) under the EU’s GMP regulations, which the EMA conceded can be confusing. Read More