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Most Read Articles
Product Highlight - ADACEL
01 Dec 2020
Tetanus toxoid 5 Lf, diphtheria toxoid 2 Lf, pertussis toxoid 2.5 mcg, filamentous haemagglutinin 5 mcg, fimbriae types 2 and 3 5 mcg, pertactin 3 mcg
Spotlight on multidrug-resistant gram-negative infections: New developments for an old problem
Dr. Hsu Li Yang, Dr. Tan Thuan Tong, Dr. Andrea Kwa, 08 Jan 2021
Antimicrobial resistance has become increasingly dire as the rapid emergence of drug resistance, especially gram-negative pathogens, has outpaced the development of new antibiotics. At a recent virtual symposium, Dr Hsu Li Yang, Vice Dean (Global Health) and Programme Leader (Infectious Diseases), NUS Saw Swee Hock School of Public Health, presented epidemiological data on multidrug-resistant (MDR) gram-negative bacteria (GNB) in Asia, while Dr Tan Thuan Tong, Head and Senior Consultant, Department of Infectious Diseases, Singapore General Hospital (SGH), focused on the role of ceftazidime-avibactam in MDR GNB infections. Dr Andrea Kwa, Assistant Director of Research, Department of Pharmacy, SGH, joined the panel in an interactive fireside chat, to discuss challenges, practical considerations, and solutions in MDR gram-negative infections. This Pfizer-sponsored symposium was chaired by Dr Ng Shin Yi, Head and Senior Consultant of Surgical Intensive Care, SGH.
Standing good for heart health
Jairia Dela Cruz, 3 days ago
Spending too much time sitting cannot be good for the body, and rising to one's feet breaks up such a behaviour and yields small, but meaningful, reductions in certain cardiovascular disease (CVD) risk factors, according to the results of a meta-analysis.
Does thyroid hormone therapy provide survival benefits in subclinical hypothyroidism?
3 days ago
Use of thyroid hormone therapy does not seem to protect older adults with subclinical hypothyroidism against mortality, but it appears to confer survival benefits to those aged <65 years, results of a study have shown.

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
Product Highlight - ADACEL
01 Dec 2020
Tetanus toxoid 5 Lf, diphtheria toxoid 2 Lf, pertussis toxoid 2.5 mcg, filamentous haemagglutinin 5 mcg, fimbriae types 2 and 3 5 mcg, pertactin 3 mcg
Spotlight on multidrug-resistant gram-negative infections: New developments for an old problem
Dr. Hsu Li Yang, Dr. Tan Thuan Tong, Dr. Andrea Kwa, 08 Jan 2021
Antimicrobial resistance has become increasingly dire as the rapid emergence of drug resistance, especially gram-negative pathogens, has outpaced the development of new antibiotics. At a recent virtual symposium, Dr Hsu Li Yang, Vice Dean (Global Health) and Programme Leader (Infectious Diseases), NUS Saw Swee Hock School of Public Health, presented epidemiological data on multidrug-resistant (MDR) gram-negative bacteria (GNB) in Asia, while Dr Tan Thuan Tong, Head and Senior Consultant, Department of Infectious Diseases, Singapore General Hospital (SGH), focused on the role of ceftazidime-avibactam in MDR GNB infections. Dr Andrea Kwa, Assistant Director of Research, Department of Pharmacy, SGH, joined the panel in an interactive fireside chat, to discuss challenges, practical considerations, and solutions in MDR gram-negative infections. This Pfizer-sponsored symposium was chaired by Dr Ng Shin Yi, Head and Senior Consultant of Surgical Intensive Care, SGH.
Standing good for heart health
Jairia Dela Cruz, 3 days ago
Spending too much time sitting cannot be good for the body, and rising to one's feet breaks up such a behaviour and yields small, but meaningful, reductions in certain cardiovascular disease (CVD) risk factors, according to the results of a meta-analysis.
Does thyroid hormone therapy provide survival benefits in subclinical hypothyroidism?
3 days ago
Use of thyroid hormone therapy does not seem to protect older adults with subclinical hypothyroidism against mortality, but it appears to confer survival benefits to those aged <65 years, results of a study have shown.