'I feel like I'm drowning': thousands with cystic fibrosis wait to hear if 'life-saving' drug will be listed on PBS

27 January 2022 - Matt Dickinson was struggling to breathe when his mother rushed him to an Adelaide hospital earlier ...

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COVID-19: EMA recommends conditional marketing authorisation for Paxlovid

27 January 2022 - The EMA’s CHMP has recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid ...

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COVID-19: early access granted to Paxlovid as a curative treatment

21 January 2022 - In the context of very high circulation of SARS-CoV-2, the High Authority for Health (HAS) and the ...

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Glenmark receives NDA approval by the United States FDA for Ryaltris nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adults and paediatric patients 12 years of age and older

14 January 2022 - Ryaltris will be marketed and distributed in the United States through its partner Hikma. ...

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European Commission approves Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat children with cystic fibrosis ages 6 to 11 years

11 January 2022 - More than 1,500 children now eligible to receive a treatment targeting the underlying cause of cystic ...

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EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19

10 January 2022 - EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine ...

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Amylyx Pharmaceuticals submits marketing authorisation application for AMX0035 for the Treatment of ALS

4 January 2022 - Amylyx Pharmaceuticals today announced it has submitted a marketing authorisation application to the EMA's CHMP for ...

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TGA grants provisional determination to AstraZeneca for COVID-19 prophylaxis and treatment, tixagevimab and cilgavimab (Evusheld)

4 January 2022 - On 4 January 2022, the TGA granted a further provisional determination to AstraZeneca in relation to ...

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Amylyx Pharmaceuticals announces FDA acceptance and priority review of new drug application for AMX0035 for the treatment of ALS

29 December 2021 - Amylyx Pharmaceuticals today announced that the U.S. FDA has accepted for review its new drug application for ...

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Valeo Pharma obtains public reimbursement for Enerzair Breezhaler and Atectura Breezhaler in Quebec and Nova Scotia

15 December 2021 - Public reimbursement now includes Alberta, Quebec and Nova Scotia, representing approximately 37% of the Canadian population. ...

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Veru announces FDA approval of Entadfi, a new treatment for benign prostatic hyperplasia

13 December 2021 - Commercialisation will start early calendar year 2022. ...

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Heron Therapeutics announces FDA approval of a significant indication expansion for Zynrelef

9 December 2021 - Approval provides a significantly broader indication for Zynrelef, now covering approximately 7 million procedures a year. ...

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Mayne Pharma and Mithra announce TGA approval of Nextstellis oral contraceptive

29 November 2021 - Mayne Pharma and Mithra Pharmaceuticals are very pleased to announce the TGA has approved the novel combined ...

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Vertex announces reimbursement agreement in Spain for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat people with cystic fibrosis 12 years and older with at least one F508del mutation in the CFTR gene

19 November 2021 - With this reimbursement agreement approximately 700 people with cystic fibrosis now have access to a CFTR ...

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TGA grants provisional determination to AstraZeneca for COVID-19 preventative treatment, tixagevimab and cilgavimab (Evusheld)

9 November 2021 - On 4 November 2021, the TGA granted provisional determination to AstraZeneca in relation to the COVID-19 treatment ...

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