CAPR Dr. George Tidmarsh, a longtime biotech executive and adjunct professor, replaced Vinay Prasad as FDA’s acting head of the Center for Biologics Evaluation and Research—a change welcomed by biotech leaders who anticipate faster approvals and broader access to experimental treatmentsCapricor Therapeutics, Inc. stock forum
CAPR Dr. George Tidmarsh, a longtime biotech executive and adjunct professor, replaced Vinay Prasad as FDA’s acting head of the Center for Biologics Evaluation and Research—a change welcomed by biotech leaders who anticipate faster approvals and broader access to experimental treatmentsCAPR Capricor Therapeutics Inc Good news for CAPR, Dr. Vinay Prasad departs FDA amid conservative criticism, controversy. All rare disease drugs will have a now have a better chance. Watch new webinar Addressing all technical details of design issue addressed for Hope-2 and FDA approach guideline clarification. should be up on Capricor website sometime this week. Hope-3 is complete and ready to go to the FDA.CAPR Deramiocel in HOPE-2 is the first therapeutic trial in Duchenne muscular dystrophy to show stabilisation of upper limb function and improved cardiac structure and function relative to placebo. Below blue line is cardiac improvement 100% slowdown of deterioration. Second image shows improved limb function shows 70 percent slowdown. They will submit hope-3 data when FDA meeting is set. This will be the safest and only heart therapy for DMD.CAPR Webinar to review the current status of Capricor’s Biologics License Application (BLA) for Deramiocel, provide information about cardiomyopathy in Duchenne, and take questions from the community. The webinar will be held on Tuesday, July 29, 2025, at 1:00 p.m. ET. Register through Capricor website, (press release) for zoom. 🚀🚀🚀
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President-elect Donald Trump has nominated Dr. Marty Makary, a surgeon and public policy researcher at Johns Hopkins University, to lead the U.S. Food and Drug Administration FDA.
Dr. Makary’s approach to the FDA’s drug approval process emphasizes streamlining procedures to expedite the availability of treatments for serious conditions, such as Duchenne Muscular Dystrophy DMD He has expressed concerns about the agency’s “cozy relationship” with drug manufacturers and has criticized specific FDA decisions, including the approval of certain COVID-19 vaccines and Alzheimer’s treatments.
In summary, Dr. Makary’s nomination indicates a potential shift in the FDA’s drug approval process, aiming to balance expedited access to treatments for diseases like DMD with rigorous scientific evaluation to maintain public trust and safety.
President-elect Donald Trump has nominated Dr. Marty Makary, a surgeon and public policy researcher at Johns Hopkins University, to lead the U.S. Food and Drug Administration FDA.
Dr. Makary’s approach to the FDA’s drug approval process emphasizes streamlining procedures to expedite the availability of treatments for serious conditions, such as Duchenne Muscular Dystrophy DMD He has expressed concerns about the agency’s “cozy relationship” with drug manufacturers and has criticized specific FDA decisions, including the approval of certain COVID-19 vaccines and Alzheimer’s treatments.
In summary, Dr. Makary’s nomination indicates a potential shift in the FDA’s drug approval process, aiming to balance expedited access to treatments for diseases like DMD with rigorous scientific evaluation to maintain public trust and safety.
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