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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