Most Read Articles
Dr Margaret Shi, 18 May 2020

A blood test is shown to be feasible and safe for early detection of multiple cancers in women with no current or known history of cancer, enabling early treatment with curative intent in a subset of individuals.

Natalia Reoutova, 20 May 2020

Cancer patients infected with coronavirus disease 2019 (COVID-19) appear to be at higher risk of severe outcomes, including death, but cancer type and treatment serve as better predictors, according to recent research presented at the American Association for Cancer Research (AACR) 2020 Virtual Annual Meeting I.

At the time of writing, COVID-19 has spread to more than 200 countries and territories, affecting an estimated 4.5 million people and killing over 300,000. Cancer, on the other hand, is newly diagnosed in 18 million people and takes the lives of 10 million every year.

“We have invited physician scientists who are at the epicentre of the COVID-19 pandemic, taking care of patients with cancer. They gathered prospective information to understand the effects of COVID-19 on patients with cancer, are testing new treatments, and are making this knowledge available to the global research community, so we can all benefit from their experience,” said Professor Antoni Ribas from UCLA Medical Center, Los Angeles, California, US, chairperson of the COVID-19 and cancer plenary session of the meeting.

Natalia Reoutova, 28 May 2020

Fasting-mimicking diet (FMD) cycles in combination with endocrine therapy (ET) cause metabolic changes in hormone receptor (HR)-positive breast cancer patients analogous to those observed in animal models, where they are associated with anticancer activity.

Christina Lau, 12 May 2020

Patients with advanced non-small-cell lung cancer (NSCLC) who have a past medical history of pneumonitis are at increased risk of treatment-related pneumonitis (TAP) from immune checkpoint inhibitor (ICI) regimens or chemotherapy alone, an analysis of clinical trial and real-world data has shown.

Original New Drug Application Approvals by US FDA (16 - 31 May 2018)

31 May 2018

New drug applications approved by US FDA as of 16 - 31 May 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.

LUCEMYRA

  • Active Ingredient(s): Lofexidine
  • Strength: 0.18 MG
  • Dosage Form: Tablet
  • Company: US Worldmeds LLC
  • Approval Date: 16 May 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults
  • Approved Label16/05/2018 (PDF)
AIMOVIG
  • Active Ingredient(s): Erenumab-AOOE
  • Strength: 70 MG/ML
  • Dosage Form: Injectable
  • Company: Amgen Inc
  • Approval Date: 17 May 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for the preventive treatment of migraine in adults
  • Approved Label17/05/2018 (PDF)
LOKELMA
  • Active Ingredient(s): Sodium zirconium cyclosilicate
  • Strength: 5 G; 10 G
  • Dosage Form: Powder for oral suspension
  • Company: AstraZeneca Pharms
  • Approval Date: 18 May 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for hyperkalemia in adults
  • Approved Label18/05/2018 (PDF)
DOPTELET
  • Active Ingredient(s): Avatrombopag
  • Strength: 20 MG
  • Dosage Form: Tablet
  • Company: Akarx Inc
  • Approval Date: 21 May 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure
  • Approved Label: 21/05/2018 (PDF)
YONSA
  • Active Ingredient(s): Abiraterone acetate
  • Strength: 125 MG
  • Dosage Form: Tablet
  • Company: Sun Pharma Global
  • Approval Date: 22 May 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer 
  • Approved Label: 22/05/2018 (PDF)
PROGRAF
  • Active Ingredient(s): Tacrolimus
  • Strength: 0.2 MG; 1 MG
  • Dosage Form: Suspension
  • Company: Astellas
  • Approval Date: 24 May 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants
  • Approved Label: 24/05/2018 (PDF)
HALOBETASOL PROPIONATE
  • Active Ingredient(s): Halobetasol propionate
  • Strength:0.05%
  • Dosage Form: Fiber, extended release; periodontal
  • Company: Therapeutics Inc
  • Approval Date: 25 May 2018
  • Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
  • Indication(s): Indicated for the topical treatment of plaque psoriasis in patients eighteen (18) years of age and older
  • Approved Label: 24/05/2018 (PDF)
PALYNZIQ
  • Active Ingredient(s): Pegvaliasee-PQPZ
  • Strength: 2.5MG/O.5ML; 10MG/0.5ML; 20MG/ML
  • Dosage Form: Injectable
  • Company: Biomarin Pharm
  • Approval Date: 25 May 2018
  • Submission Classification: Not available
  • Indication(s): Indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management
  • Approved Label: 24/05/2018 (PDF)
IMVEXXY
  • Active Ingredient(s): Estradiol
  • Strength:4 MCG; 10 MCG
  • Dosage Form: Vaginal insert
  • Company: TherapeuticsMD Inc
  • Approval Date:29 May 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause
  • Approved Label: 29/05/2018 (PDF)
CONSENSI
  • Active Ingredient(s): Amlodipine; Celecoxib
  • Strength: (2.5 MG; 200 MG); (5 MG; 200 MG); (10 MG; 200 MG)
  • Dosage Form: Tablet
  • Company: Kitov Pharmaceuticals
  • Approval Date: 31 May 2018
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate
  • Approved Label: 31/05/2018 (PDF)
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Most Read Articles
Dr Margaret Shi, 18 May 2020

A blood test is shown to be feasible and safe for early detection of multiple cancers in women with no current or known history of cancer, enabling early treatment with curative intent in a subset of individuals.

Natalia Reoutova, 20 May 2020

Cancer patients infected with coronavirus disease 2019 (COVID-19) appear to be at higher risk of severe outcomes, including death, but cancer type and treatment serve as better predictors, according to recent research presented at the American Association for Cancer Research (AACR) 2020 Virtual Annual Meeting I.

At the time of writing, COVID-19 has spread to more than 200 countries and territories, affecting an estimated 4.5 million people and killing over 300,000. Cancer, on the other hand, is newly diagnosed in 18 million people and takes the lives of 10 million every year.

“We have invited physician scientists who are at the epicentre of the COVID-19 pandemic, taking care of patients with cancer. They gathered prospective information to understand the effects of COVID-19 on patients with cancer, are testing new treatments, and are making this knowledge available to the global research community, so we can all benefit from their experience,” said Professor Antoni Ribas from UCLA Medical Center, Los Angeles, California, US, chairperson of the COVID-19 and cancer plenary session of the meeting.

Natalia Reoutova, 28 May 2020

Fasting-mimicking diet (FMD) cycles in combination with endocrine therapy (ET) cause metabolic changes in hormone receptor (HR)-positive breast cancer patients analogous to those observed in animal models, where they are associated with anticancer activity.

Christina Lau, 12 May 2020

Patients with advanced non-small-cell lung cancer (NSCLC) who have a past medical history of pneumonitis are at increased risk of treatment-related pneumonitis (TAP) from immune checkpoint inhibitor (ICI) regimens or chemotherapy alone, an analysis of clinical trial and real-world data has shown.