The Pre-Investigational New Drug Application (IND) Consultation Program fosters early communications between sponsors and new drug review divisions to provide guidance on the data necessary to warrant ...
Received positive feedback on New Drug Application submission via the 505(b)(2) pathway-Company leveraging existing human pharmacokinetic data ...
Tharimmune (THAR) announced in addition to developing TH104 for the proposed indication of moderate-to-severe chronic pruritus in patients with ...
today announced the submission of its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a phase 2 clinical trial in ALS. This pivotal step marks a ...
today announced that the U.S. Food and Drug Administration (FDA) has cleared Altesa's new Investigational New Drug (IND) application for vapendavir for the treatment of rhinovirus infections in ...
Aldeyra Therapeutics surges 15% to $4.10, following an upgrade from Oppenheimer citing the company's development plan for resubmitting a New Drug Application ... FDA gives a path forward for ...
Advancing CMC plan to meet requirements of a New Drug Application BRIDGEWATER ... Opioids", for which we have submitted a Pre-Investigational New Drug Application ("PIND"). With respect to ...
Advancing CMC plan to meet requirements of a New Drug Application "This feedback from the FDA marks a significant milestone for Tharimmune and for individuals who may face the threat of ...
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