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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Crysvita is a drug developed by Ultragenyx Pharmaceutical and Tokyo-based Kyowa Kirin Co. Ltd., a specialty pharmaceutical company.
The FDA approved a supplemental New Drug Application for Tazverik (tazemetostat) for the treatment of two distinct follicular lymphoma (FL) indications.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 19, 2020.
This is the second such biomarker-specific approval for Keytruda. The first biomarker-specific approval came in 2017.
Novartis is the first company to the finish line with an approved treatment for Adult-Onset Still’s Disease (AOSD), a rare autoinflammatory disease of unknown origin.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 17, 2020.
The game was reviewed through the agency’s de novo pathway and as a result, creates a new class of digital therapeutics.
The approval was based on monotherapy clinical data from a trial in 105 adults with SCLC whose disease progressed after platinum-based chemotherapy.
The FDA indicated that, based on new evidence, there was not enough supporting evidence for the two drugs to be considered effective in treating COVID-19.
The U.S. Food and Drug Administration (FDA) approved ViiV Healthcare’s Tivicay PD (dolutegravir) in combination with other antiretroviral drugs for children with HIV.