FDA
Gelesis’ weight loss device, Plenity, has been gaining popularity since the FDA approved its commercialization, but some in the medical community question whether its popularity is deserved.
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Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
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The FDA said that arimoclomol, which has been studied and submitted for NPC indication, needs further data to support its use in this rare, progressive genetic disorder.
New data shows Zolgensma, Novartis’ gene therapy for spinal muscular atrophy, has the potential to be used presymptomatically in juveniles.
Three other drug contenders that work similarly to Biogen’s drug are currently in clinical trials and expecting data relatively soon.
The U.S. FDA approved Ayvakit for the treatment of adult patients with advanced sytematic mastocytosis (SM), advanced SM, and mast cell leukemia.
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