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 FDA gave the green light to Amgen’s Lumakras under accelerated approval as a treatment for patients with KRAS mutation whose disease has worsened over time.
The latest news in COVID-19 includes support for an investigation into the origins of the virus, a new naming system, and legal discussions of whether employers can mandate vaccination.
The U.S. FDA is starting off the summer months with a busy week after the Memorial Day holiday in the U.S. Here’s a look.
The question before the committee was whether the benefits of teplizumab outweigh the risks as it voted 10-7 in favor of the drug to delay clinical type 1 diabetes mellitus.
The FDA has a massive backlog of site inspections due to the pandemic. To address the problem, the agency made its Resiliency Roadmap outlining its priorities.
Fennec is looking for a second chance to approve PEDMARK, its pediatric chemotherapy-induced hearing loss prevention drug, as it resubmits its NDA for the agent to the U.S. FDA.
Bristol Myers Squibb has been busy the last two weeks with a string of approvals, positive clinical trial updates and deals. Here’s a look.
Determined to take its next-generation engineered cell therapies to the next level, BlueRock teams up with Senti Biosciences with futuristic medicines in mind.
The EUA was granted base on interim data from the Phase III COMET-ICE trial in high-risk adult outpatients.
This is the second IND to come out of the two companies’ collaboration. They will initiate a Phase I trial of the drug in cardiometabolic diseases.