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 ...

In 2023, the FDA rejected a small pharmaceutical company's new drug application (NDA ... Whether advocating CMC strategy, directing CMC operations, or developing CMC submission content that ...

CRL focused on CMC; no clinical issues relating to etripamil raised $69.7M in cash, cash equivalents and short-term investments as of December 31, 2024 MONTREAL and CHARLOTTE, N.C., March 28, 2025 ...

CRL focused on CMC; no clinical issues relating to etripamil raised $69.7M in cash, cash equivalents and short-term investments as of December 31, 2024 MONTREAL and CHARLOTTE, N.C., March 28, 2025 ...

Manufacturing and Controls (CMC) issues to be addressed: Company to submit additional information on nitrosamine impurities based on new draft guidance issued after the NDA submission; and An ...

Urcosimod in Phase 2 clinical trial for Neuropathic Corneal Pain shown to have Long-Term StabilityUrcosimod stable in ...

Milestone Pharmaceuticals hit another bump in the road in its quest to get Cardamyst approved for paroxysmal supraventricular ...

December 2024, immediately following the approval of the world's first mesenchymal stromal cells clinical trial, the U.S. FDA ...

The FDA’s letter did not express concerns about the clinical safety or efficacy of etripamil but highlighted two Chemistry, Manufacturing, and Controls (CMC) issues that require resolution.

The Chemistry, Manufacturing and Controls (CMC) section is near completion. The team is on track for a 2Q:25 submission.