Pharmaceuticals, Biotechnology and Life Sciences
The European Medicines Agency has accepted a variation to the Marketing Authorisation Application (MAAv) for Tagrisso (osimertinib) from Astrazeneca.
US Food and Drug Administration (FDA) has approved a new indication for AstraZeneca’s Faslodex(fulvestrant), expanding the indication to include use with…
Mereo BioPharma has made a deal with AstraZeneca for an exclusive license, including an option to acquire, AZD9668, an oral inhibitor…
AstraZeneca and Merck said Wednesday that th eUS Food and Drug Administration (FDA) has accepted and granted priority review for a…
The US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for AstraZeneca’s Imfinzi (durvalumab) for the treatment of…
AstraZeneca Monday said that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the…
Top-line results from the AstraZeneca’s Phase III AMPLIFY trial for Duaklir met its primary endpoints, demonstrating a statistically-significant improvement in lung function in patients with moderate to very severe stable chronic obstructive pulmonary disease (COPD) compared to each individual component, the company said Thursday. In addition, aclidinium bromide achieved its primary bronchodilation endpoint of demonstrating non-inferiority to tiotropium bromide 18µg once-daily.
AstraZeneca and Amgen on Thursday published results from the PATHWAY Phase IIb trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma. The trial results were published in the New England Journal of Medicine. The PATHWAY trial achieved its primary efficacy endpoint, showing annual asthma exacerbation rate reductions.
AstraZeneca’s and Merck’s Lynparza new tablet’s formulation has been approved as maintenance treatment for women with platinum-sensitive recurrent ovarian cancer regardless of BRCA-mutation status, the companies said Friday.
The US Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for acalabrutinib, a highly-selective, potent, Bruton tyrosine kinase (BTK) inhibitor, developed by AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma. This potential new medicine is in development for the treatment of multiple B-cell and other cancers.