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The FDA proposes to extend the new drug application pathway to include therapeutic indications that have not previously been available for nonprescription drugs, Commissioner Scott Gottlieb said on Tuesday in announcing a new draft guidance on the initiative. Read More
The European Medicines Agency issued the first report on its open access policy for clinical data submitted by sponsors in their marketing applications for new drugs. Read More
A federal court issued a preliminary injunction against Dr. Reddy’s generics for Indivior’s addiction treatment Suboxone (buprenorphine and naloxone) pending the outcome of a patent challenge. Read More
A new report from four Democratic senators claims contacts between Novartis and President Donald Trump’s former personal attorney and Novartis were more extensive than previously disclosed. Read More