Most Read Articles
Dr Margaret Shi, Yesterday

The triplet regimen of encorafenib, binimetinib and cetuximab provides significant and clinically relevant benefits in overall survival (OS) and objective response rate (ORR) in patients with BRAFV600E-mutated metastatic colorectal cancer (mCRC) who experience disease progression after one or two previous regimens, according to results of an interim analysis of the BEACON CRC trial.

Pank Jit Sin, 30 Oct 2017
Barely has the dust settled on e-cigarettes before the next cigarette replacement product, based on the heat-not-burn (HNB) principle, emerges to derail tobacco control efforts. 
Christina Lau, 14 Oct 2019

Denosumab can be of benefit to patients with unresectable giant cell tumour of bone (GCTB) and those who are likely to experience significant morbidity after surgical resection of GCTB.

Natalia Reoutova, 18 Sep 2019

A retrospective analysis of seven clinical trials demonstrated that neratinib-based therapy is safe and effective in Asian patients with metastatic HER2-positive breast cancer.

Original New Drug Application Approvals by US FDA (1 -15 June 2018)

15 Jun 2018

New drug applications approved by US FDA as of 1-15 June 2018 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.

    FULPHILA

  • Active Ingredient(s): Pegfilgrastim-JMDB
  • Strength: 6 mg/0.6 ml
  • Dosage Form: Injectable;injection
  • Company: Mylan GMBH
  • Approval Date: June 04, 2018
  • Submission Classification: Not applicable
  • Indication(s): Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
  • Approved Label: 06/04/2018(PDF)

  MOXIDECTIN
  • Active Ingredient(s): Moxidectin
  • Strength: 2 mg
  • Dosage Form: Tablet;oral
  • Company: Medicines Development for Global Health
  • Approval Date:  June 13, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older.
  • Approved Label: 06/13/2018(PDF)
LYMEPAK
  • Active Ingredient(s): Doxycycline Hyclate
  • Strength: 100 mg
  • Dosage Form: Tablet;oral
  • Company: Chartwell Pharma
  • Approval Date: June 15, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for  the treatment of early Lyme disease (as evidenced by erythema migrans) due to Borrelia burgdorferi in adults and pediatric patients 8 years of age and older weighing 45 kg and above.
  • Approved Label: 06/15/2018(PDF)
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Editor's Recommendations
Most Read Articles
Dr Margaret Shi, Yesterday

The triplet regimen of encorafenib, binimetinib and cetuximab provides significant and clinically relevant benefits in overall survival (OS) and objective response rate (ORR) in patients with BRAFV600E-mutated metastatic colorectal cancer (mCRC) who experience disease progression after one or two previous regimens, according to results of an interim analysis of the BEACON CRC trial.

Pank Jit Sin, 30 Oct 2017
Barely has the dust settled on e-cigarettes before the next cigarette replacement product, based on the heat-not-burn (HNB) principle, emerges to derail tobacco control efforts. 
Christina Lau, 14 Oct 2019

Denosumab can be of benefit to patients with unresectable giant cell tumour of bone (GCTB) and those who are likely to experience significant morbidity after surgical resection of GCTB.

Natalia Reoutova, 18 Sep 2019

A retrospective analysis of seven clinical trials demonstrated that neratinib-based therapy is safe and effective in Asian patients with metastatic HER2-positive breast cancer.