Scholar Rock navigates FDA's Complete Response Letter for Apitegromab, aiming for swift resubmission to address spinal ...
On Tuesday, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Biogen Inc.’s (NASDAQ: ...
FDA cites Catalent Indiana issues in Scholar Rock's SMA drug review; European approval decision expected in 2026, with ...
Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to dramatically improving the lives of children and ...
The FDA in September issued two rejections for spinal muscular atrophy therapies—both linked to manufacturing problems—and ...
In its rejection letter, the FDA flagged problems at a third-party fill-finish site owned by Novo Nordisk. Issues at this ...
See why Scholar Rock Holding Corporation remains a Strong Buy despite regulatory setbacks, with key catalysts ahead and ...
According to the National Institute of Neurological Disorders and Stroke, there are currently only three FDA-approved ...
If you are following Biogen (BIIB), the latest twist from the FDA might have you reevaluating what is next for the stock. On Tuesday, Biogen announced that the agency declined to approve its ...
A new international study has shown that treating babies with spinal muscular atrophy before symptoms appear can dramatically improve outcomes.Emily ...
In today’s Pharmaceutical Executive Daily, we cover the market reaction to Trump’s Tylenol–autism claim, the FDA’s complete ...
Kasey Mumford, 24, says it took 23 appointments before doctors diagnosed her newborn son, Chester, with a rare condition ...
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