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Fewer than a third of new drugs approved by the FDA and the European Medicines Agency over the past decade had high therapeutic value, a team of U.S. and Swiss researchers found. Read More
The FDA said the drug could lead to opioid “stacking,” as patients will need an additional opioid following treatment, increasing the risk of adverse effects. Read More
Avenue Therapeutics has a received a Complete Response Letter (CRL) from the FDA regarding its new drug application (NDA) for intravenous tramadol, meant for treating acute pain in adults. Read More
Johnson & Johnson (J&J) has reached an advance purchase deal with the European Commission to provide up to 200 million doses of its COVID-19 vaccine candidate. Read More
The FDA has hit Mesoblast’s biologics license application (BLA) for Ryoncil (remestemcel-L) with a complete response letter despite a strong vote by the agency’s expert advisory committee vote in favor of the stem cell treatment for pediatric steroid-refractory acute graft vs. host disease. Read More