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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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 22, 2020.
It does not require healthcare workers and first responders to conduct the test using personal protective equipment. Therefore, it should prevent the risk of transmitting the virus.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 21, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 20, 2020.
The U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib) for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement.
Tukysa came out of Project Orbis, a multinational partnership between the FDA, the Australian Therapeutic Goods Administration, Health Canada, Health Sciences Authority and Swissmedic.
Here’s a look at what’s on the U.S. Food and Drug Administration’s schedule for the next two weeks.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 17, 2020.
Jelmyto is the first and only non-surgical treatment for patients with this indication. Here’s everything you need to know about it.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for April 16, 2020.