Amylyx Pharmaceuticals announces EMA validation of marketing authorisation application for AMX0035 for the treatment of ALS

25 February 2022 - Amylyx Pharmaceuticals today announced that its marketing authorisation application to the EMA CHMP for AMX0035 (sodium phenylbutyrate ...

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Cystic fibrosis community disappointed with PTAC recommendations

23 February 2022 - New Zealand’s cystic fibrosis community received disappointing news today with a recommendation to PHARMAC that reduces ...

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Valeo Pharma obtains public reimbursement for Enerzair Breezhaler and Atectura Breezhaler in Ontario, Manitoba and New Brunswick

24 February 2022 - Private insurance coverage across Canada exceeds 90%. ...

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PHARMAC recommends funding cystic fibrosis medicine Trikafta but needs more funding

23 February 2022 - PHARMAC’s clinical experts are recommending cystic fibrosis drug Trikafta be funded for those aged over 12 ...

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PHARMAC’s clinical experts recommend funding Trikafta

23 February 2022 - PHARMAC today announces its clinical advisory committee PTAC has recommended funding cystic fibrosis treatment Trikafta with ...

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‘New hope’: breakthrough cystic fibrosis treatment to be listed on PBS

14 February 2022 - Health Minister Greg Hunt says the breakthrough treatment for cystic fibrosis, Trikafta, will soon be able ...

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China approves use of Pfizer's COVID drug Paxlovid

12 February 2022 - China's medical products regulator said on Saturday it has given conditional approval for Pfizer's COVID-19 drug ...

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'Lifesaving' cystic fibrosis drug Trikafta recommended for inclusion on PBS

1 February 2022 - Thousands of people with cystic fibrosis are one step closer to accessing a 'lifesaving' drug, after ...

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'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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