The US Food and Drug Administration (FDA) has released a new final guidance document intended to assist sponsors in determining whether a research study involving human subjects may be conducted ...
IND Filing and Concurrent RMAT Request Position XytriX™ as a Potential Breakthrough Biotherapeutic for More Than 500 Million People Living with Osteoarthritis Our concurrent request for RMAT ...
Abpro Holdings Inc. and Celltrion Inc. have announced the submission of an IND application to the FDA for ABP-102 (CT-P72), a HER2 x CD3 T-cell engager. Pending clearance, a phase I trial in patients ...
The US Food and Drug Administration (FDA) has found itself mired in - quite literally - a crappy situation. In February 2013, the agency announced that it would reach out to the public in an attempt ...
Dogwood licensed SP16 to treat cancer-related pain from partner and regulatory sponsor Serpin Pharma The SP16 Phase 1b trial fully funded by the National Cancer Institute; Patient enrollment expected ...
Co., Ltd., today announced that its Type II Drug Master File (DMF) for COPPER [64Cu] CHLORIDE FOR RADIOLABELLING has been listed as active by the U.S. Food and Drug Administration (FDA) under DMF No.
(RTTNews) - Traws Pharma, Inc. (TRAW) announced the filing of a U.S. IND application with the FDA for tivoxavir marboxil, a potential CAP-dependent endonuclease inhibitor as a single oral tablet ...
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 ...
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