FDA
Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
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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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This test will give healthcare providers a single result to confirm an HIV diagnosis with patients and differentiate between HIV-1 and HIV-2.
The U.S. government has financially backed the development of six different vaccine candidates aimed at the novel coronavirus. Although billions of dollars have been appropriated to the pandemic, at least four of those potential preventative treatments are predicted to fail in the clinic.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 2, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 31, 2020.
With a new regulatory approval in hand for its FoundationOne Liquid CDx, Foundation Medicine said it plans for the product to be available for commercial use by Friday, Aug. 28.
The U.S. Food and Drug Administration (FDA) approved Italy-based Cassiopea SpA’s acne treatment Winlevi. Let’s look at how this new acne treatment was developed.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 26, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 24, 2020.
The U.S. Food and Drug Administration (FDA) approved Novartis’ Kesimpta (ofatumumab) for relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 21, 2020.