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Mappel Industria, a Brazil-based company received a warning letter from the FDA due to significant violations of cGMP regulations for finished pharmaceuticals. Read More
A proposal to extend the market exclusivity of new drugs approved in India from four years to 10 is dividing the industry, as some argue that the measure would promote safety and others contend it delays generic competition. Read More
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