Telix Pharmaceuticals' said its new drug application in the U.S. for an imaging agent received regulatory approval. The Melbrourne, Australia-based biopharmaceutical company said Friday that the Food ...
The clinical-stage biopharmaceutical firm is pushing its NMDA platform while building a national network of psychiatric ...
Xeris Biopharma Holdings has received regulatory approval for a new use of its Gvoke liquid glucagon in gastrointestinal ...
PDS Biotechnology (NASDAQ:PDSB) said on Thursday it received U.S. FDA clearance for its Investigational New Drug application ...
"The FDA’s acceptance of our New Drug Application takes us another step closer to bringing relacorilant to patients with hypercortisolism," said Joseph Belanoff, M.D., Corcept’s Chief ...
The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.
Phase 2b and phase 3 trials may begin in 2025 and 2026, respectively. A new drug application is anticipated for 2029. The investigational new drug application for Zabalafin Hydrogel for the ...
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for finerenone for the treatment of ...
A delay in drug approvals in the US market remains a concern for Aurobindo. The company stated that eight ANDAs (abbreviated ...
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