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The federal government is looking for a partner to collaborate on developing a new treatment for anxiety and depression based on a chemical by-product produced when the body breaks down the drug ketamine. Read More
KemPharm has appealed the FDA’s complete response letter for its opioid Apadaz, contending that the company’s clinical evidence merits an approval with abuse-deterrent claims. Read More
Prospects look somewhat grim for the life sciences industry in the UK, regardless of whether the country decides to completely divorce itself from the EU or do a “soft exit,” a think tank says. Read More
Syntese has received a Form 483 after an inspection revealed sanitation, quality and laboratory control issues at the Denmark-based API maker. Read More
FDA reviewers expressed strong concerns over the possibility of liver damage related to solithromycin treatment ahead of an advisory committee meeting Friday on whether the drug should be approved as an antibiotic for community-acquired bacterial pneumonia. Read More