Rosanna Sutherby, Pharm.D.

For now, only the Pfizer and Moderna vaccines have full FDA approval, but many candidates are in phase 2 or 3 trials.

The setback for GlaxoSmithKline comes amid a multicompany race to develop a vaccine against respiratory syncytial virus infections.

Pyrukynd, developed by Agios Pharmaceuticals, is a PK activator and the first in this drug class. The company is also awaiting approval by the European Medicines Agency, and a decision is expected by the end of 2022.

Asundexian is an oral factor XIa inhibitor currently under phase 2 trials for potential secondary thrombosis prevention in patients with non-cardioembolic ischemic stroke, atrial fibrillation, or recent myocardial infarction.

The oral formulation of the muscle relaxant was also approved as a treatment for spasticity associated with spinal cord injuries.

Pfizer and BioNTech initiated an application yesterday (Feb. 1) for emergency use authorization (EUA) of their COVID-19 vaccine for children ages 6 months through 4 years.

The dual orexin receptor antagonist (DORA) from a Swiss drugmaker will be available in May 2022.

The Janssen drug is the only DOAC available in an oral suspension, which facilitates pediatric weight-based dosing.

Leo Pharma's Adbry (tralokinumab-ldrm) is the second, FDA-approved biologic for atopic dermatitis. Dupixent (dupilumab) was the first.

Leqvio (inclisiran) is the first small interfering RNA therapy approved to lower LDL cholesterol in certain adults at risk for life-threatening cardiovascular events.