Most Read Articles
Pearl Toh, 22 Oct 2020
The combination therapy comprising carfilzomib, cyclophosphamide and dexamethasone (KCd) is effective, with a tolerable safety profile, in an Asian cohort with high-risk multiple myeloma (MM) — thus providing a more economical alternative as a potential upfront regimen in resource-limited settings, according to leading experts during a myeloma education webinar.
Roshini Claire Anthony, 13 Nov 2020

Diabetes is a key risk factor for heart failure (HF), which is the leading cause of hospitalization in patients with or without diabetes. SGLT-2* inhibitors (SGLT-2is) have been shown to reduce the risk of hospitalization for HF (HHF) regardless of the presence or absence of diabetes.

Pearl Toh, 6 days ago
Inhaled corticosteroid (ICS) should be the mainstay of long-term asthma management — such is the key message of the latest Singapore ACE* Clinical Guidance (ACG) for asthma, released in October 2020.
Elvira Manzano, 17 Nov 2020
Invasive fungal infections, particularly those caused by Candida species, are common in hospitalized, immunocompromised, or critically ill patients and are associated with considerable morbidity and mortality.

Original New Drug Application Approvals by US FDA (16 - 30 April 2020)

29 Apr 2020
New drug applications approved by US FDA as of 16 - 30 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.

EMERPHED
  • Active Ingredient(s): Ephedrine sulfate
  • Strength: 50 mg/10 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Nexus Pharms
  • Approval Date: 17 April 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
  • Approved Label17 April 2020 (PDF)

TUKYSA
  • Active Ingredient(s): Tucatinib
  • Strength: 50 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Seattle Genetics
  • Approval Date: 17 April 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable  or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
  • Approved Label17 April 2020 (PDF)

PEMAZYRE
  • Active Ingredient(s): Pemigatinib
  • Strength: 4.5 mg; 9 mg; 13.5 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Incyte Corp.
  • Approval Date: 17 April 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults with previously treated, unresectable locally advances or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
  • Approved Label17 April 2020

TRODELVY
  • Active Ingredient(s): Sacituzumab govitecan-hziy
  • Strength: 180 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Immuomedics, Inc.
  • Approval Date: 22 April 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.
  • Approved Label22 April 2020 (PDF)

ONGENTYS
  • Active Ingredient(s): Opicapone
  • Strength: 25 mg; 50 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Neurocrine
  • Approval Date: 24 April 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes.
  • Approved Label24 April 2020 (PDF)

MILPROSA
  • Active Ingredient(s): Progesterone
  • Strength: 1.78 g
  • Dosage Form(s) / Route(s): Ring; vaginal
  • Company: Ferring Pharmaceutical, Inc.
  • Approval Date: 29 April 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.
  • Approved Label29 April 2020 (PDF)
Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Oncology - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
Pearl Toh, 22 Oct 2020
The combination therapy comprising carfilzomib, cyclophosphamide and dexamethasone (KCd) is effective, with a tolerable safety profile, in an Asian cohort with high-risk multiple myeloma (MM) — thus providing a more economical alternative as a potential upfront regimen in resource-limited settings, according to leading experts during a myeloma education webinar.
Roshini Claire Anthony, 13 Nov 2020

Diabetes is a key risk factor for heart failure (HF), which is the leading cause of hospitalization in patients with or without diabetes. SGLT-2* inhibitors (SGLT-2is) have been shown to reduce the risk of hospitalization for HF (HHF) regardless of the presence or absence of diabetes.

Pearl Toh, 6 days ago
Inhaled corticosteroid (ICS) should be the mainstay of long-term asthma management — such is the key message of the latest Singapore ACE* Clinical Guidance (ACG) for asthma, released in October 2020.
Elvira Manzano, 17 Nov 2020
Invasive fungal infections, particularly those caused by Candida species, are common in hospitalized, immunocompromised, or critically ill patients and are associated with considerable morbidity and mortality.