The US Food and Drug Administration (FDA) on Monday released new draft guidance to assist sponsors of treatments for rare diseases in planning and conducting more efficient and productive ...
We encourage the sponsors we work with to view FDA as a valuable development partner. In our experience, they have been very interested in engaging with sponsors to encourage the development of new ...
Companies Advance Collaborative Clinical Development of iTOL-102: A Potential Cure for Diabetes Without the Need for Chronic Life-long Immune Suppression Kadimastem and iTolerance believe that the ...
Scheduled a pre-IND meeting with the FDA, indicating progress in the regulatory pathway for EL-22. EL-22's novel approach targets muscle preservation for patients undergoing weight loss treatments, ...
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address ...
BOSTON and ATLANTA, April 03, 2024 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor ...
Kadimastem Ltd. and Itolerance Inc. have held a type B pre-IND meeting with the FDA regarding the development of ITOL-102, an investigational biologic for the treatment and potential cure of type 1 ...
FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject clinical trial ESTERO, FL / ACCESS Newswire / January 7, 2026 / Aspire Biopharma ...
ESTERO, FLORIDA / ACCESS Newswire / December 2, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) (“Aspire” or the “Company”), a developer of a multi-faceted patent-pending drug delivery technology ...
Resvita Bio Inc. has held a pre-IND meeting with the FDA for RVB-003, its lead investigational therapy for Netherton syndrome. The FDA’s feedback gives the company a pathway to submit an IND for ...
NLS Pharmaceutics Ltd. (Nasdaq: NLSP”) (“NLS”) and Kadimastem Ltd. (“Kadimastem”), a clinical-stage company specializing in "off-the-shelf" allogeneic cell therapy products for neurodegenerative ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results