Government
The FDA approved a supplemental New Drug Application for Tazverik (tazemetostat) for the treatment of two distinct follicular lymphoma (FL) indications.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 19, 2020.
The U.S. Court of Appeals upheld a ruling that the Trump administration does not have the legal authority to mandate that drug companies disclose the list price of medications in television advertisements.
This is the second such biomarker-specific approval for Keytruda. The first biomarker-specific approval came in 2017.
Novartis is the first company to the finish line with an approved treatment for Adult-Onset Still’s Disease (AOSD), a rare autoinflammatory disease of unknown origin.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 17, 2020.
The game was reviewed through the agency’s de novo pathway and as a result, creates a new class of digital therapeutics.
The warning came only a few hours after the FDA rescinded Emergency Use Authorization (EUA) for hydroxychloroquine and chloroquine for the treatment of COVID-19.
The approval was based on monotherapy clinical data from a trial in 105 adults with SCLC whose disease progressed after platinum-based chemotherapy.
The FDA indicated that, based on new evidence, there was not enough supporting evidence for the two drugs to be considered effective in treating COVID-19.
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