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The majority of fixed-dose combination analgesics and antipsychotics on the Indian market have never been approved, leading to the sale of millions of doses of unsafe drugs, a new study concludes. Read More
Toronto, Canada-based Intellipharmaceutics expects to file an NDA for its opioid painkiller Rexista XR within the next year, after receiving notification from the FDA that it won’t need to conduct Phase III clinical trials. Read More
Akorn Pharmaceuticals is voluntarily recalling more than 362,000 units of sulfamethoxazole/trimethoprim oral suspension because the sulfamethoxazole portion doesn’t dissolve in liquid. Read More
In observance of the Memorial Day holiday, Drug Industry Daily will not be published Monday, May 25. The next issue will be published Tuesday, May 26. Read More
The European Medicines Agency has issued draft guidance describing the types of evidence developers of gene therapies need to support marketing authorization — saying very small firms, which comprise the majority of this segment, may not be familiar with the regulatory process. Read More
The House Energy & Commerce Committee released a new version of the 21st Century Cures Act that scales back the rare pediatric disease priority review voucher program. Read More
The Arkansas attorney general agreed to a $7.75 million settlement with Johnson & Johnson over its marketing of the antipsychotic Risperdal, just over a year after the state’s top court reversed a $1.2 billion verdict. Read More
The FDA has revised Bristol-Myers Squibb’s breakthrough therapy designation for its daclatasvir/sofosbuvir combination hepatitis C therapy to cover patients with advanced cirrhosis or whose infection recurs after a liver transplant. Read More