duchenne muscular dystrophy

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Duchenne muscular dystrophy, FDA and Capr

FDA rejects Capricor’s cell therapy for Duchenne muscular dystrophy

The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment continues.

BioPharma Dive · 1d

FDA turns back Capricor’s Duchenne cell therapy

The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the agency during deramiocel’s review.

Stocktwits on MSN · 1d

Capricor Stock Plunges Pre-Market After US FDA Declines Approval For Muscular Disorder Therapy

Capricor Therapeutics (CAPR) on Friday said the U.S. Food and Drug Administration (FDA) has refused to approve its lead cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy.

STAT1d

Pharmalittle: We’re reading about a FDA offer on drug reviews, a Moderna Covid approval, and more

FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...

Capricor: Maintaining Hold Rating In Light Of Deramiocel Complete Response Letter

Capricor Therapeutics is expected to release data from the phase 3 HOPE-3 trial in Q3'25, thus presenting a potential path ...

The American Journal of Managed Care2d

Accommodations as DMD Progresses Incur Substantial Household Costs

Families caring for individuals with Duchenne muscular dystrophy (DMD) face significant financial burdens from necessary home ...

Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy

FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial ...

pharmaphorum4d

Taiho's late-stage Duchenne candidate fails trial

Taiho Pharmaceutical has suffered a blow to its near-term pipeline after a drug candidate for Duchenne muscular dystrophy ...

The American Journal of Managed Care1d

TAS-205 Misses Primary End Point in Phase 3 DMD Trial

TAS-205 showed no significant impact on motor function in patients with Duchenne muscular dystrophy (DMD), highlighting the ongoing search for effective treatments for the rare condition.

SunStar8h

Student with rare muscle condition shows disability doesn’t mean inability

They said he wouldn’t make it this far. He’s proving them wrong -- one push at a time.” At just 16, Nathan Espina is defying ...

STAT1d

Questions about the FDA’s ‘radical transparency’ efforts

Happy Friday. Today, we talk about the stem cell fire sale at CIRM, and about the FDA’s move to release a limited batch of ...

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