Most Read Articles
4 days ago
Roche recently announced their targeted therapy combination pertuzumab (Perjeta®)-trastuzumab (Herceptin®) plus conventional chemotherapy for treatment of early breast cancer in those with a subtype known as HER2-positive. The combination was previously used in the metastatic breast cancer setting, where cancer had already spread. There, it was able to prolong cancer sufferers’ lives significantly. Because of its effectiveness, the two-drug combo is new available for treatment of early HER2-positive breast cancer to further reduce the risk of metastasis or cancer recurrence. HER2-positive breast cancers usually spread faster and affect younger women and make up about one quarter of all newly diagnosed breast cancers. 
Pearl Toh, 07 Mar 2019
Sacituzumab govitecan, a novel investigational antibody-drug conjugate, showed clinical activity in patients with metastatic urothelial carcinoma (mUC) who had progressed following standard therapy, including treatment with checkpoint inhibitors, according to an early study presented at GUCS 2019.
29 Jan 2019
A curative strategy for smoldering multiple myeloma (SMM) that involves induction therapy with carfilzomib, lenalidomide and dexamethasone (KRd) followed by high-dose melphalan and autologous stem cell transplantation (ASCT), KRd consolidation, and maintenance with lenalidomide and dexamethasone has demonstrated promising results in a phase II trial.
29 Jan 2019
Carfilzomib in combination with dexamethasone (Kd) is effective and safe in patients with multiple myeloma (MM) relapsing on or after lenalidomide and those with lenalidomide-refractory disease, a combined analysis of carfilzomib trials has shown.

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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Most Read Articles
4 days ago
Roche recently announced their targeted therapy combination pertuzumab (Perjeta®)-trastuzumab (Herceptin®) plus conventional chemotherapy for treatment of early breast cancer in those with a subtype known as HER2-positive. The combination was previously used in the metastatic breast cancer setting, where cancer had already spread. There, it was able to prolong cancer sufferers’ lives significantly. Because of its effectiveness, the two-drug combo is new available for treatment of early HER2-positive breast cancer to further reduce the risk of metastasis or cancer recurrence. HER2-positive breast cancers usually spread faster and affect younger women and make up about one quarter of all newly diagnosed breast cancers. 
Pearl Toh, 07 Mar 2019
Sacituzumab govitecan, a novel investigational antibody-drug conjugate, showed clinical activity in patients with metastatic urothelial carcinoma (mUC) who had progressed following standard therapy, including treatment with checkpoint inhibitors, according to an early study presented at GUCS 2019.
29 Jan 2019
A curative strategy for smoldering multiple myeloma (SMM) that involves induction therapy with carfilzomib, lenalidomide and dexamethasone (KRd) followed by high-dose melphalan and autologous stem cell transplantation (ASCT), KRd consolidation, and maintenance with lenalidomide and dexamethasone has demonstrated promising results in a phase II trial.
29 Jan 2019
Carfilzomib in combination with dexamethasone (Kd) is effective and safe in patients with multiple myeloma (MM) relapsing on or after lenalidomide and those with lenalidomide-refractory disease, a combined analysis of carfilzomib trials has shown.