NK1 antagonists are drugs that block the neurokinin-1 receptor, aiding in the treatment of nausea, vomiting, and psychiatric disorders.

Merck announced it got an FDA Complete Response Letter regarding its New Drug Application for gefapixant.

The terms New Molecular Entity (NME) and New Chemical Entity (NCE) are sometimes used interchangeably; however, they are distinct.

Rallybio Corporation revealed early Phase 1 trial results for RLYB116, a novel drug with prolonged action and subcutaneous administration in low volumes.

Melatonin receptor agonists are drugs that activate melatonin receptors, aiding in the treatment of sleep disorders.

Almirall S.A. has recently launched a phase I clinical trial to assess the safety profile, pharmacokinetic properties, immunogenic potential, and pharmacodynamic effects of ALM223.

To optimize drug dosage adjustments for individual patient profiles in the context of combination therapy, several factors should be considered.

Tiziana Life Sciences Ltd. has announced the start of a Phase 2a trial, assessing the efficacy and safety of two doses of intranasal foralumab compared to placebo in patients with non-active secondary-progressive multiple sclerosis.

TLR7 agonists are compounds that activate the Toll-like receptor 7, stimulating the immune system against viral infections.

Mabwell announced the NMPA's approval of its IND application for 8MW0511, an innovative injectable recombinant fusion protein drug.

In the U.S. FDA context, "Requirement/Commitment Status" generally refers to a manufacturer's or sponsor's obligations for regulatory approval, post-approval studies, or marketing authorization conditions for drugs, devices, or regulated products.

Telix Pharmaceuticals has submitted a BLA to the U.S. FDA for TLX250-CDx (Zircaix™), a PET scan diagnostic agent for clear cell renal cell carcinoma.