The definition of IBD in the Guideline refers to the date of the first marketing approval for any product containing the active substance granted to any company in any country in the world.
OncoResponse, a clinical-stage biotech innovator specializing in immunotherapy derived from elite cancer survivors, announced the first dosing in a Phase 1/2 trial of OR502.
ASC Therapeutics has reported the inaugural administration to a patient in their Phase I/IIa study for their prime drug, ASC618, conducted at Arkansas Children's Hospital.
There are various types of drug applications submitted to the FDA, including Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Over-the-Counter Drugs (OTC), and Biologic License Application (BLA).
Longboard Pharmaceuticals, Inc., a company focused on developing new treatments for neurological conditions, has announced the start of a Phase 1 trial. This randomized, double-blind, placebo-controlled study will assess their drug candidate, LP659, in a Single Ascending Dose (SAD) format.