AstraZeneca Pharmaceuticals

AstraZeneca Pharmaceuticals
Share

Lynparza is the first and only PARP inhibitor approved for use beyond ovarian cancer
Lynparza reduced the risk of disease progression or death by 42%
compared to standard of care chemotherapy
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug...

AstraZeneca Pharmaceuticals

 •  December 18, 2017

Acceptance follows FDA Breakthrough Therapy Designation Tagrisso granted Priority Review AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase...

AstraZeneca Pharmaceuticals

 •  November 28, 2017

Acceptance is based on positive Phase III FLAURA trial results
AstraZeneca today announced that the European Medicines Agency has accepted a variation to the Marketing Authorisation Application (MAAv) for Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical...

AstraZeneca Pharmaceuticals

 •  November 15, 2017

Faslodex in combination with abemaciclib showed 16.4 months of progression-free survival (PFS) Second approval in three months expands treatment options for women with HR+, HER2- advanced breast cancer 15 November 2017 AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication for Faslodex...

AstraZeneca Pharmaceuticals

 •  November 14, 2017

Fasenra distinctively targets and rapidly depletes eosinophils and is the first respiratory biologic with an 8-week maintenance dosing schedule
FDA approval based on Phase III programme demonstrating up to 51% reduction in asthma exacerbations, significant improvement in lung function and a 75% reduction in daily oral steroid use AstraZeneca and...

AstraZeneca Pharmaceuticals

 •  October 31, 2017

Phase III trial evaluating Imfinzi and epacadostat in patients with locally-advanced, unresectable non-small cell lung cancer is expected to begin in the first half of 2018
AstraZeneca and MedImmune, its global biologics research and development arm, today announced the expansion of their clinical collaboration with Incyte Corporation. As part...

AstraZeneca Pharmaceuticals

 •  October 23, 2017

New formulation of once-weekly exenatide in an improved device provides significant HbA1c reduction with added benefit of weight loss 23 October 2017 AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon in an improved...

AstraZeneca Pharmaceuticals

 •  October 18, 2017

Lynparza has the potential to offer a new treatment option for patients with germline BRCA-mutated, HER2-negative metastatic breast cancer Regulatory submission acceptance is first for a PARP inhibitor beyond ovarian cancer 18 October 2017 AstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the US and Canada) today announced that the...

AstraZeneca Pharmaceuticals

 •  October 17, 2017

Imfinzi granted Priority Review Acceptance follows FDA’s Breakthrough Therapy Designation 17 October 2017 AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for the...

AstraZeneca Pharmaceuticals

 •  October 9, 2017

Designation based on positive Phase III FLAURA trial results Sixth Breakthrough Therapy Designation for an AstraZeneca New Oncology medicine
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with...