Approvals
Both MannKind and United Therapeutics entered into a global and exclusive licensing and collaboration agreement to develop and commercialize Tyvaso DPI.
In an eight page letter to U.S. DOH and Human Services Secretary Xavier Becerra, Public Citizen said Woodcock and other FDA officials should resign.
The StrataGraft is designed to help heal patients who have received thermal burns that would ultimately require a skin graft. Here’s everything about it.
The study drug is a once-daily, two-week therapy developed by Sage Therapeutics and Biogen for major depressive disorder (MDD) and postpartum depression (PPD).
The company noted it would continue to assess the STAR study’s complete data set before confirming its future plans for clinical development of timrepigene emparvovec.
Avenue Therpeutics is facing the heat of rejection from FDA once again for its IV non-opioid painkiller tramadol. Here are the reasons behind the rejections
The FDA accepted its pre-Investigational New Drug request for a cell therapy treatment that could be a key factor in controlling HIV.
The month of June continues to be busy for the U.S. Food and Drug Administration. There are three PDUFA dates on the calendar for this week. Here’s a look.
Beigene presented results from three pivotal trials at the 26th EHA2021 Virtual Congress for the effectiveness of their checkpoint inhibitor tislelizumab in relapsed or refractory lymphoma.
Aaron Kesselheim, a professor of Medicine at Harvard Medical School and has served on the advisory committee since 2015, has stepped down.
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