Caprock Mining Corp

The FDA under President Trump is abandoning its decades-old policy of convening outside expert panels to review individual drug applications, with officials claiming these meetings are redundant and time-consuming.

Capricor Therapeutics has dosed the first subjects in a Phase 1 clinical trial of its StealthX exosome-based vaccine, marking the first-in-human evaluation of this novel platform.

Recent FDA complete response letters for Replimune's RP1 and Capricor's CAP-1002 underscore increasing regulatory emphasis on analytical validation, tech transfer execution, and manufacturing controls in immunotherapy development.

Up to 3,500 FDA staffers received termination notices following a Supreme Court ruling that found the government's HHS overhaul to be lawful.

The FDA's Center for Biologics Evaluation and Research director Vinay Prasad unilaterally canceled an advisory committee meeting for Capricor Therapeutics' Duchenne muscular dystrophy cell therapy due to skepticism about the treatment.

Beam Therapeutics received FDA orphan drug designation for its sickle cell disease treatment, providing regulatory incentives for this rare genetic disorder affecting hemoglobin production.

The exosome therapeutics field is experiencing significant growth with preparations underway for the first clinical trials and substantial investment through partnerships and pipeline acquisitions.

• Capricor Therapeutics achieves significant milestone as FDA grants priority review for Deramiocel, potentially accelerating approval timeline for Duchenne muscular dystrophy treatment. • The priority review designation underscores the urgent unmet medical need in DMD treatment, with a target action date expected within 6 months rather than the standard 10-month review period. • If approved, Deramiocel would represent a novel therapeutic approach for DMD patients, offering a potential new treatment option in the limited landscape of available therapies.

Capricor Therapeutics has completed its Biologics License Application (BLA) submission to the FDA for deramiocel to treat Duchenne muscular dystrophy (DMD) cardiomyopathy.

Capricor Therapeutics' deramiocel has been granted Orphan Drug and Advanced Therapy Medicinal Product (ATMP) designations by the EMA for treating Duchenne muscular dystrophy (DMD).