AstraZeneca

26 Maj 2023 08:06

Ultomiris approved in Japan for the prevention of relapses in patients with neuromyelitis optica spectrum disorder (NMOSD)

Ultomiris (ravulizumab) has been approved in Japan as the first and only long-acting C5 complement inhibitor for the prevention of relapses in patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica.

10 Maj 2023 08:01

Ultomiris approved in the EU for adults with neuromyelitis optica spectrum disorder (NMOSD)

Ultomiris (ravulizumab) has been approved in the European Union (EU) as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD).

11 April 2023 08:01

Update to contractual arrangements between AstraZeneca, Swedish Orphan Biovitrum AB and Sanofi

AstraZeneca, Swedish Orphan Biovitrum AB (publ) (Sobi) and Sanofi have updated and simplified their contractual arrangements relating to the development and commercialisation of nirsevimab in the US. Given the upcoming launch of nirsevimab in the US and other markets, simplification of the prior arrangements clarifies the roles and responsibilities of relevant parties.
Under the updated arra

21 Februari 2023 08:04

ReSViNet 2023 data reinforce AstraZeneca’s commitment to help prevent Respiratory Syncytial Virus in infants

AstraZeneca will showcase new data across its Vaccines and Immune Therapies Respiratory Syncytial Virus (RSV) portfolio at the 7th Respiratory Syncytial Virus Foundation (ReSViNET) Conference in Lisbon, Portugal from 22-24 February 2023, reinforcing its commitment to help protect infants from RSV.

2 Februari 2023 15:01

Tezspire approved for self-administration in the US with a new pre-filled pen

AstraZeneca and Amgen’s Tezspire (tezepelumab) has been approved in the US for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. Tezspire is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.

13 Januari 2023 08:03

Tezspire approved for self-administration in the EU in a new pre-filled pen

AstraZeneca’s Tezspire (tezepelumab) has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma.

11 Januari 2023 14:03

Airsupra (PT027) approved in the US for asthma

Airsupra (albuterol/budesonide), formerly known as PT027, has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older.

5 Januari 2023 08:00

Nirsevimab US regulatory submission accepted for the prevention of RSV lower respiratory tract disease in infants and children up to age 24 months

AstraZeneca’s Biologics License Application (BLA) for nirsevimab has been accepted for review by the US Food and Drug Administration (FDA) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants entering or during their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second..

9 November 2022 08:25

PT027 recommended by FDA advisory committee as new rescue treatment for asthma

First and only rescue medication recommended for US approval that has been shown to reduce severe exacerbations.

The Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 16 to 1 that the data support a favourable benefit risk assessment for the use of PT027 (albuterol/budesonide) for the treatment of asthma in people aged 18 years and older. In a

1 November 2022 08:01

Vaxzevria receives full Marketing Authorisation in the EU for the prevention of COVID-19

AstraZeneca's COVID-19 vaccine, Vaxzevria (ChAdOx1-S [Recombinant]), has been granted full Marketing Authorisation (MA) in the European Union (EU).

27 September 2022 08:02

Tezspire approved in Japan for the treatment of severe asthma

AstraZeneca’s Tezspire (tezepelumab) has been approved in Japan for the treatment of bronchial asthma in patients with severe or refractory disease in whom asthma symptoms cannot be controlled with mid- or high-dose inhaled corticosteroids and other long-term maintenance therapies.

21 September 2022 08:02

Tezspire approved in the EU for the treatment of severe asthma

AstraZeneca’s Tezspire (tezepelumab) has been approved in the European Union (EU) as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product.

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