Most Read Articles
Natalia Reoutova, 21 Nov 2019

Final analysis of the POEMS (Prevention of Early Menopause) study finds that breast cancer (BC) patients treated with the gonadotrophin-releasing hormone agonist (GnRHa) goserelin, in addition to chemotherapy, are more likely to avoid premature menopause and to become pregnant without negatively impacting disease-related outcomes.

Jairia Dela Cruz, 4 days ago
In breast cancer, especially hormone-negative tumours, an ultrasound-guided core biopsy (CNB) is useful for predicting pathologic complete response (pCR) to chemotherapy and may thus help to avoid surgery for some patients, a study has found.
Christina Lau, 14 Feb 2019
Progress in the treatment of rare cancers has been named Advance of the Year by the American Society of Clinical Oncology (ASCO).
Natalia Reoutova, 19 Nov 2019

A 70-month prospective study in Southern Chinese women, sponsored by the World Cancer Research Fund, finds no evidence of pre-diagnosis soy intake negatively affecting mortality or recurrence among breast cancer survivors. On the contrary, the results indicate that moderate soy intake may be associated with better outcomes.

Original New Drug Application Approvals by US FDA (16 - 30 June 2018)

30 Jun 2018

New drug applications approved by US FDA as of 16-30 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.

NOCDURNA

  • Active Ingredient(s): Desmopressin Acetate
  • Strength: 27.7 mcg; 53.3 mcg
  • Dosage Form: Tablet; sublingual
  • Company: Ferring Pharms Inc
  • Approval Date: June 21, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for r the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void. 
  • Approved Label: 06/21/2018(PDF)
ABLYSINOL
  • Active Ingredient(s): Dehydrated Alcohol
  • Strength: 1 ml; 5 ml
  • Dosage Form: Injectable; injection
  • Company: Belcher Pharms LLC
  • Approval Date: June 21, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not Applicable
  • Approved Label: Not Applicable 
ZEMDRI
  • Active Ingredient(s): Plazomicin
  • Strength: 50 mg/ml
  • Dosage Form: Injectable; injection
  • Company: Achaogen Inc
  • Approval Date: June 25, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of patients 18 years of age or older with Complicated Urinary Tract Infections (cUTI) including Pyelonephritis. 
  • Approved Label: 06/25/2018(PDF)
EPIDIOLEX
  • Active Ingredient(s): Cannabidiol
  • Strength: 100 mg/ml
  • Dosage Form: Solution; oral
  • Company: GW Research Ltd
  • Approval Date: June 25, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated  of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.
  • Approved Label: 06/25/2018(PDF)
BRAFTOVI
  • Active Ingredient(s): Encorafenib
  • Strength: 50 mg; 75 mg
  • Dosage Form: Capsule; oral
  • Company: Array Biopharma Inc
  • Approval Date: June 27, 2018
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated  for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test 
  • Approved Label: 06/27/2018(PDF)
MEKTOVI
  • Active Ingredient(s): Binimetinib
  • Strength: 15 mg
  • Dosage Form: Tablet; oral
  • Company: Array Biopharma Inc
  • Approval Date: June 27, 2018
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Not applicable
  • Approved Label: Not Applicable 
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Most Read Articles
Natalia Reoutova, 21 Nov 2019

Final analysis of the POEMS (Prevention of Early Menopause) study finds that breast cancer (BC) patients treated with the gonadotrophin-releasing hormone agonist (GnRHa) goserelin, in addition to chemotherapy, are more likely to avoid premature menopause and to become pregnant without negatively impacting disease-related outcomes.

Jairia Dela Cruz, 4 days ago
In breast cancer, especially hormone-negative tumours, an ultrasound-guided core biopsy (CNB) is useful for predicting pathologic complete response (pCR) to chemotherapy and may thus help to avoid surgery for some patients, a study has found.
Christina Lau, 14 Feb 2019
Progress in the treatment of rare cancers has been named Advance of the Year by the American Society of Clinical Oncology (ASCO).
Natalia Reoutova, 19 Nov 2019

A 70-month prospective study in Southern Chinese women, sponsored by the World Cancer Research Fund, finds no evidence of pre-diagnosis soy intake negatively affecting mortality or recurrence among breast cancer survivors. On the contrary, the results indicate that moderate soy intake may be associated with better outcomes.