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, 6 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.
Stephen Padilla, 5 days ago
Circulating miR-155 may be potentially used as a diagnostic and therapeutic monitoring marker in breast cancer, suggests an Indonesian study presented at the 2019 Asia Congress of the European Society for Medical Oncology (ESMO Asia 2019).
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).

Original New Drug Application Approvals by US FDA (01 - 15 March 2019)

15 Mar 2019
New drug applications approved by US FDA as of 01 - 15 March 2019 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.

SPRAVATO
  • Active Ingredient(s): Esketamine
  • Strength: 56 mg; 84 mg
  • Dosage Form(s) / Route(s): Spray; Nasal
  • Company: Janssen Pharms
  • Approval Date: 05 Mar 2019
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults.
  • Approved Label05 Mar 2019 (PDF)

TRAZIMERA
  • Active Ingredient(s): Trastuzumab-qyyp
  • Strength: 420 mg
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Pfizer Inc
  • Approval Date: 11 Mar 2019
  • Submission Classification: Not Available
  • Indication(s): Indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults.
    • The treatment of HER2-overexpressing breast cancer.
    • The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
  • Approved Label11 Mar 2019 (PDF)

ROCKLATAN
  • Active Ingredient(s): Netarsudil; Latanoprost
  • Strength: 0.02%; 0.005%
  • Dosage Form(s) / Route(s): Solution; Ophthalmic
  • Company: Aerie Pharms Inc
  • Approval Date: 12 Mar 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
  • Approved Label: 12 Mar 2019 (PDF)

TETRACAINE HYDROCHLORIDE
  • Active Ingredient(s): Tetracaine hydrochloride
  • Strength: 5%
  • Dosage Form(s) / Route(s): Solution; Ophthalmic
  • Company: Paragon Bioteck
  • Approval Date: 12 Mar 2019
  • Submission Classification:
  • Indication(s): Indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.
  • Approved Label: 12 Mar 2019 (PDF)
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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, 6 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.
Stephen Padilla, 5 days ago
Circulating miR-155 may be potentially used as a diagnostic and therapeutic monitoring marker in breast cancer, suggests an Indonesian study presented at the 2019 Asia Congress of the European Society for Medical Oncology (ESMO Asia 2019).
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).