The FDA accepted a new drug application for SYD-101 to slow the progression of pediatric myopia and assigned a Prescription ...

The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.

One of the most highly anticipated FDA decisions this month is for Alnylam Pharmaceuticals, which is seeking to expand the ...

Specialty pharmaceutical company PharmaTher Holdings’ drug application for Ketamine has received a June 4 approval goal date, advancing approval of the drug in the U.S. PharmaTher said it is ...

PDS Biotechnology (NASDAQ:PDSB) said on Thursday it received U.S. FDA clearance for its Investigational New Drug application ...

Phase 1/2 trial evaluating the proprietary combination to be run under CRADA with the National Cancer InstituteSecondVersamune®platform candidate ...

Ketamine stock PharmaTher Holdings (CSE:PHRM) has received an amendment acknowledgement letter from the U.S. Food and Drug ...

"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 ...

today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for SYD-101 and has assigned a Prescription Drug User Fee Act (PDUFA) target action ...

FP008 is designed for patients with solid tumors that have not responded to existing immunotherapies targeting PD-1.