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.
FEATURED STORIES
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 morning, Mylan announced the launch of its new generic offering, dimethyl fumarate delayed-release capsules for the treatment of relapsing forms of multiple sclerosis.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 19, 2020.
The U.S. Food and Drug Administration approved Genentech’s Enspryng (satralizumab-mwge) as a subcutaneous treatment for adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 17, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 14, 2020.
The U.S. Food and Drug Administration (FDA) approved another therapy for Duchenne muscular dystrophy (DMD), this time NS Pharma’s Viltepso (viltolarsen).
Olinvyk is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 12, 2020.
Genentech, a Roche company, announced the U.S. Food and Drug Administration (FDA) had approved its Evrysdi (risdiplam) for spinal muscular atrophy (SMA) in adults and children two months of age and older.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 7, 2020.