Late-breaking presentation at MDA to feature Phase 3 HOPE-3 results supporting Deramiocel in Duchenne muscular dystrophyHOPE-3 clinical study ...
Abbott is facing a warning letter from FDA regarding its Freestyle Libre family of continuous glucose monitoring (CGM) devices for use in diabetes management. The agency said it received responses ...
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CAPR stock rallied nearly 30% so far this week — here’s the February FDA catalyst investors are betting on
The February filing centers on Deramiocel’s Phase 3 Hope-3 data, following the FDA's request for the full clinical study report without requiring new trials. ・The company's Phase 3 results showed ...
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Capricor or Sarepta: Two DMD stocks enter a high-stakes week – which one has more upside?
Capricor is preparing a February submission to the FDA for its DMD cell therapy Deramiocel, following a formal request for the full Phase 3 Hope-3 clinical study report. ・Koyfin expects Sarepta to ...
The FDA slammed ExThera with a warning letter for deviating from the regulatory agency’s guidelines by promoting and selling ...
Jan 30 (Reuters) - Shares of Corcept Therapeutics (CORT.O), opens new tab fell 16% on Friday after a corrected "complete response letter" from the U.S. Food and Drug Administration showed the agency ...
A batch of untitled letters posted on the FDA’s database in recent days takes aim at what the agency has termed “false or misleading” drug ads from the likes of Novo Nordisk, argenx and Sobi. Among ...
Please provide your email address to receive an email when new articles are posted on . The FDA was not concerned about the drug’s pharmacokinetics. Concerns included packaging, patient use and ...
A few months after sending an untitled letter to ARS Pharmaceuticals, taking issue with certain aspects of a TV commercial about its epinephrine nasal spray, the FDA is reiterating its concerns about ...
I will now hand the conference over to your speaker host for today [indiscernible]. Please go ahead. Thank you, operator. Good morning, and welcome to today's call. On today's call, I'm joined by Dan ...
WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to participate in its PreCheck pilot program, designed to boost domestic drug supply by speeding ...
Deficiencies limited to packaging and administration Company believes it can rapidly resolve deficiencies and expects to resubmit as early as Q3 2026 Remains well-capitalized and anticipates ending ...
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