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.

Factor Xa inhibitors are anticoagulant drugs that inhibit Factor Xa, a key enzyme in blood coagulation.

OliX Pharmaceuticals has disclosed encouraging initial safety outcomes and signs of effectiveness from a Phase 1 study evaluating OLX10212 for treating age-related macular degeneration.

The Prescription Drug User Fee Act (PDUFA) of 1992 allows the FDA to charge fees to applicants submitting drug applications or sponsors of approved prescription drugs.

Arrowhead Pharmaceuticals has submitted an application to begin an early-stage clinical trial, evaluating ARO-DM1 in patients with Myotonic Dystrophy Type 1.

HMG-CoA reductase inhibitors are a type of medication used to lower cholesterol levels in the body and are commonly referred to as statins.

Internationally recognized biotech company CSL, in partnership with Arcturus Therapeutics, has made public that the Ministry of Health, Labor and Welfare in Japan has officially sanctioned the use of ARCT-154.

Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.

Rallybio Reveals Initial Multi-Dose Results from Finalized Phase 1 Evaluation on Safety and Drug Dynamics for RLYB212, a Monoclonal Antibody Targeting HPA-1a to Avert Thrombocytopenia in Infants and Newborns.

Type of AE: This refers to any unfavorable and unintended sign (including abnormal laboratory findings not meeting the criteria for an AE) that occurs during or after treatment with the test article.