News & Updates

New drug applications approved by US FDA as of 01-15 November 2021 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Treatment with fenfluramine in patients with Dravet syndrome (DS) appears to produce a marked reduction in day-to-day seizure burden and provide prolonged periods of convulsive seizure-free days, as shown in a study.

Women who have a documented history of penicillin allergy should undergo allergy tests during pregnancy to avoid exposure to potentially less effective broad-spectrum antibiotics, according to a small study presented at ACAAI 2021.

The noninferiority finding between transcatheter vs surgical aortic valve replacement (TAVR vs SAVR) in intermediate-risk patients with severe aortic stenosis (AS) holds up through 5 years, according to long-term data of the SURTAVI trial presented at TCT 2021, providing reassurance that the less invasive procedure performs just as good in the elderly population.

In the treatment of patients with acute respiratory distress syndrome (ARDS), the use of aspirin improves neither oxygenation index nor other physiological outcomes, according to the results of a phase II study.

The varenicline-containing nasal spray OC-01 appears beneficial in the treatment of dry eye disease, producing improvements in natural tear film production and patient-reported symptoms with a tolerable safety profile, as shown in the phase III trial ONSET-2.