Craniofacial abnormalities affect a significant proportion of society. Cleft lip and/or palate, for example, occurs in 1 per 500–700 births, depending on geography and ethnicity. The costs in terms of morbidity, psychological disturbance, and social and workplace exclusion are considerable for patients and their families, and society. The average incidence of new cleft cases is 2 clefts per 1,000 live births in the combined populations of Thailand, Bangladesh, Bhutan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Nepal, Pakistan, Philippines, Singapore, Sri Lanka, and Vietnam.1
Cerebral palsy (CP) is one of the leading causes of childhood disability. It has been defined as ‘a disorder of movement and posture, causing activity limitation that is attributed to non-progressive disturbances that occurred in the developing fetal or infant brain’.
New drug applications approved by US FDA as of 1 - 15 June 2017 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.