FDA
Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.
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BioSpace looks back at 2025 and where the FDA is going in 2026.
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 4, 2020.
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.