The US Food and Drug Administration (FDA) on Monday released new draft guidance to assist sponsors of treatments for rare diseases in planning and conducting more efficient and productive ...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, ...

TNX-102 SL is a potential first-in-class treatment for targeting the disturbed sleep associated with depression TNX-102 SL is FDA-approved for the treatment of fibromyalgia CHATHAM, N.J., Sept. 18, ...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address ...

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 ...

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 ...

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 ...

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 ...