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Capsule endoscopy feasible for iron deficiency anaemia diagnosis
24 May 2020
The use of capsule endoscopy (CE) appears to be effective in the diagnosis of iron deficiency anaemia (IDA), yielding a 33.9-percent yield in this study, with 65.8 percent of patients undergoing further workup and 12.7 percent requiring therapeutic intervention.
Drinking filtered coffee may reduce mortality risk
Roshini Claire Anthony, 2 days ago

For coffee drinkers, drinking filtered coffee may be tied to a lower mortality risk, including cardiovascular disease (CVD)-related mortality, a study from Norway suggested.
Eating behaviours mediate link between risk factors in first 1,000 days and adiposity at 6 years
4 days ago
Eating behaviours have been shown to moderate the relationship between cumulated risk factors in the first 1,000 days and adiposity outcomes at 6 years of age, which underscores modifiable behavioural targets for interventions, reports a study.
NIV may reduce mortality but increase COVID-19 transmission in hospital workers
Stephen Padilla, 3 days ago
Use of noninvasive ventilation (NIV), similar to invasive mechanical ventilation (IMV), appears to lessen mortality but may increase the risk for transmission of the novel coronavirus disease (COVID-19) in healthcare workers, suggest the results of a study.

Original New Drug Application Approvals by US FDA (01 - 15 April 2020)

15 Apr 2020
New drug applications approved by US FDA as of 01 - 15 April 2020 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.

KOSELUGO
  • Active Ingredient(s): Selumetinib
  • Strength: 10 mg; 25 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: AstraZeneca LP
  • Approval Date: 10 April 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
  • Approved Label: 10 April 2020 (PDF)

HELIUM, USP
  • Active Ingredient(s): Not available
  • Strength: Not available
  • Dosage Form(s) / Route(s): Gas; inhalataion
  • Company: ILMO Products Company
  • Approval Date: 14 April 2020
  • Submission Classification: Medical Gas
  • Indication(s): Not available
  • Approved Label: Not available

JELMYTO
  • Active Ingredient(s): Mitomycin
  • Strength: Not available
  • Dosage Form(s) / Route(s): Solution; pyelocalyceal
  • Company: Urogen Pharma, Ltd.
  • Approval Date: 15 April 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).
  • Approved Label: 15 April 2020 (PDF)
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Most Read Articles
Capsule endoscopy feasible for iron deficiency anaemia diagnosis
24 May 2020
The use of capsule endoscopy (CE) appears to be effective in the diagnosis of iron deficiency anaemia (IDA), yielding a 33.9-percent yield in this study, with 65.8 percent of patients undergoing further workup and 12.7 percent requiring therapeutic intervention.
Drinking filtered coffee may reduce mortality risk
Roshini Claire Anthony, 2 days ago

For coffee drinkers, drinking filtered coffee may be tied to a lower mortality risk, including cardiovascular disease (CVD)-related mortality, a study from Norway suggested.
Eating behaviours mediate link between risk factors in first 1,000 days and adiposity at 6 years
4 days ago
Eating behaviours have been shown to moderate the relationship between cumulated risk factors in the first 1,000 days and adiposity outcomes at 6 years of age, which underscores modifiable behavioural targets for interventions, reports a study.
NIV may reduce mortality but increase COVID-19 transmission in hospital workers
Stephen Padilla, 3 days ago
Use of noninvasive ventilation (NIV), similar to invasive mechanical ventilation (IMV), appears to lessen mortality but may increase the risk for transmission of the novel coronavirus disease (COVID-19) in healthcare workers, suggest the results of a study.