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Original New Drug Application Approvals by US FDA (01-15 May 2023)

16 May 2023

New drug applications approved by US FDA as of 01-15 May 2023 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.

Original New Drug Application Approvals by US FDA (01-15 May 2023)

16 May 2023

Ataluren improves ambulation in nonsense mutation DMD

16 May 2023 bởi

Treatment with ataluren improves ambulatory function, as assessed by the 6-minute walk distance (6MWD) test, among boys with nonsense mutation Duchenne muscular dystrophy (nmDMD), according to the subgroup analysis of Study 041 trial presented at AAN 2023.

Ataluren improves ambulation in nonsense mutation DMD

16 May 2023

Self-compassion, relation satisfaction mediate child sexual abuse-sexual functioning link

14 May 2023

Self-compassion and relationship satisfaction play a significant role in the relationship between sexual functioning and child sexual abuse (CSA), a study has found.

Self-compassion, relation satisfaction mediate child sexual abuse-sexual functioning link

14 May 2023

Should parenteral nutrition start at a lower birth weight threshold?

11 May 2023

A recent single-centre study, which reduced the birth weight (BW) threshold for bridging parenteral nutrition (PN) from 1,500 to 1,250 g, has found that PN was initiated in about one in four infants with a BW between 1,250 and 1,500 g.

Should parenteral nutrition start at a lower birth weight threshold?

11 May 2023

Prior carbapenem use ups S. maltophilia bloodstream infection in children

09 May 2023

Children with prior use of carbapenem are at increased risk of developing Stenotrophomonas maltophilia bloodstream infection (BSI), suggests a study. In addition, admission to the paediatric intensive care unit (PICU) due to BSI and prior glycopeptide use are significantly associated with the mortality rate in patients with S. maltophilia BSIs

Prior carbapenem use ups S. maltophilia bloodstream infection in children

09 May 2023

Male sex, delayed sternal closure tied to postoperative candidemia in children with CHD

08 May 2023

Though uncommon, candidemia following cardiac surgery in children with congenital heart defect (CHD) proves to be a serious complication, reveals a study. The most common cause of non-albicans candidemia is the high frequency of fluconazole-resistant C. parapsilosis.

Male sex, delayed sternal closure tied to postoperative candidemia in children with CHD

08 May 2023

Can cutting back on caffeine help manage bed-wetting in children?

05 May 2023 bởi

Limiting caffeine intake appears to reduce the severity of primary monosymptomatic nocturnal enuresis (PMNE) in children, as shown in a study.

Can cutting back on caffeine help manage bed-wetting in children?

05 May 2023

Type 2 hepatitis no different from type 1 in terms of outcome

02 May 2023

Liver outcomes do not differ between types 1 and 2 autoimmune hepatitis presenting in childhood, reports a recent study.

Type 2 hepatitis no different from type 1 in terms of outcome

02 May 2023

Are paediatric oncology nurses well equipped in oral healthcare?

02 May 2023 bởi

A survey evaluating paediatric oncology nurses from KK Women’s and Children’s Hospital reveals that they may not be well-versed in terms of oral health knowledge.

Are paediatric oncology nurses well equipped in oral healthcare?

02 May 2023

Repeated low-level red-light therapy shows potential for myopia prevention

02 May 2023

The use of repeated low-level red-light intervention helps prevent myopia in children with premyopia, as reported in a study.

Repeated low-level red-light therapy shows potential for myopia prevention

02 May 2023

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Original New Drug Application Approvals by US FDA (01-15 May 2023)

Original New Drug Application Approvals by US FDA (01-15 May 2023)

Ataluren improves ambulation in nonsense mutation DMD

Ataluren improves ambulation in nonsense mutation DMD

Self-compassion, relation satisfaction mediate child sexual abuse-sexual functioning link

Self-compassion, relation satisfaction mediate child sexual abuse-sexual functioning link

Should parenteral nutrition start at a lower birth weight threshold?

Should parenteral nutrition start at a lower birth weight threshold?

Prior carbapenem use ups S. maltophilia bloodstream infection in children

Prior carbapenem use ups S. maltophilia bloodstream infection in children

Male sex, delayed sternal closure tied to postoperative candidemia in children with CHD

Male sex, delayed sternal closure tied to postoperative candidemia in children with CHD

Can cutting back on caffeine help manage bed-wetting in children?

Can cutting back on caffeine help manage bed-wetting in children?

Type 2 hepatitis no different from type 1 in terms of outcome

Type 2 hepatitis no different from type 1 in terms of outcome

Are paediatric oncology nurses well equipped in oral healthcare?

Are paediatric oncology nurses well equipped in oral healthcare?

Repeated low-level red-light therapy shows potential for myopia prevention

Repeated low-level red-light therapy shows potential for myopia prevention