FDA
Vera Therapeutics’ atacicept, to be marketed as Trutakna, will go up against Novartis, Otsuka and possibly Vertex in the kidney disease primary IgA nephropathy after receiving an accelerated FDA approval.
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A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.
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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.
Although the COVID-19 pandemic is waning in the U.S., there is still plenty of research and news about the disease. Here’s a look.
The new study findings may pave the way for Bristol Myers Squibb to receive additional approval for Breyanzi in a vulnerable patient population.
The Pennsylvania-based eye disease company had to change its application from an Emergency Use Authorization to a full BLA approval.