PharmExec

Scholar Rock Receives CRL from FDA for Spinal Muscular Atrophy Treatment Apitegromab

Scholar Rock navigates FDA's Complete Response Letter for Apitegromab, aiming for swift resubmission to address spinal ...

Biogen Faces FDA Setback On High-Dose Nusinersen Filing For Spinal Muscular Atrophy

On Tuesday, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Biogen Inc.’s (NASDAQ: ...

Scholar Rock's Spinal Muscular Atrophy Drug Faces FDA Delay Over Catalent Indiana Inspection

FDA cites Catalent Indiana issues in Scholar Rock's SMA drug review; European approval decision expected in 2026, with ...

FDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) Solely Related to Observations Identifi…

Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to dramatically improving the lives of children and ...
EurekAlert!

Investigating new treatments for spinal muscular atrophy

A new clinical trial has revealed encouraging results for a muscle-targeting therapy aimed at improving motor function in children and adolescents with spinal muscular atrophy, according to a ...

The Phone In - Oliver Hides takes your calls on Blue Badges, Spinal Muscular Atrophy, and New Romantics. - BBC Sounds

Oliver takes your calls on Blue Badges, spinal muscular atrophy and New Romantics.
BioSpace

Much Maligned Manufacturing Site Trips Up Scholar Rock’s Spinal Muscular Atrophy Drug

In its rejection letter, the FDA flagged problems at a third-party fill-finish site owned by Novo Nordisk. Issues at this ...
Technology Networks

Monoclonal Antibody Improves Motor Function in Spinal Muscular Atrophy Patients

A new clinical trial has revealed encouraging results for a muscle-targeting therapy aimed at improving motor function in ...
MPR

FDA Issues CRL for Apitegromab in Spinal Muscular Atrophy

Apitegromab, a fully human monoclonal antibody, works by selectively binding to the pro- and latent forms of myostatin in order to inhibit myostatin activation.
News-Medical.Net on MSN

Clinical trial reveals encouraging results for apitegromab in spinal muscular atrophy

A new clinical trial has revealed encouraging results for a muscle-targeting therapy aimed at improving motor function in ...

Scholar Rock: Despite CRL, This Is A Strong Buy With Apitegromab Expansions

See why Scholar Rock Holding Corporation remains a Strong Buy despite regulatory setbacks, with key catalysts ahead and ...
Mirage News

New Treatments Under Investigation for Spinal Atrophy

A new clinical trial has revealed encouraging results for a muscle-targeting therapy aimed at improving motor function in children and adolescents ...