Vertex announces European Commission approval for Symkevi (tezacaftor/ivacaftor) with Kalydeco (ivacaftor) for eligible children with cystic fibrosis ages 6-11 years

27 November 2020 - The combination therapy is a new treatment option for CF patients who are homozygous for F508del. ...

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Ethinyloestradiol 20 mcg with desogestrel 150 mcg and 7 inert tablets (Mercilon 28)

23 November 2020 - Ethinyloestradiol 20 mcg with desogestrel 150 mcg and 7 inert tablets (Mercilon 28) will be fully funded ...

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Aerie Pharmaceuticals receives positive CHMP opinion for Roclanda in the European Union

13 November 2020 - European Commission Decision Anticipated in Approximately Two Months. ...

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Heron Therapeutics resubmits new drug application to FDA for HTX-011 for the treatment of post-operative pain

13 November 2020 - Heron Therapeutics today announced that the new drug application was resubmitted to the U.S. FDA for HTX-011, ...

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Cystic Fibrosis Canada says 'life-changing' drug coming to Canada, but approval months away

11 November 2020 - The drug's manufacturer says it's moving forward with its cystic fibrosis medicines in Canada. ...

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Health Canada approves Maviret 8 week treatment duration for treatment naïve patients with genotype 3 compensated cirrhosis

10 November 2020 - Maviret (glecaprevir/pibrentasvir) is the only 8 week oral treatment approved for all hepatitis C virus genotypes. ...

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Bausch Health Canada receives a positive recommendation from the CADTH Canadian Drug Expert Committee for Duobrii - a novel topical anti-psoriatic prescription drug

10 November 2020 - Positive CADTH recommendation moves Duobrii closer to federal, provincial and territorial drug plan reimbursement. ...

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CADTH recommends new treatment option for patients with plaque psoriasis

30 October 2020 - The CADTH Canadian Drug Expert Committee has recommended that halobetasol (ulobetasol) propionate with tazarotene (Duobrii) be reimbursed ...

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Leo Pharma announces U.S. FDA approval for Enstilar (calcipotriene and betamethasone dipropionate) foam U.S. Prescribing Information update to include data in long-term use in plaque psoriasis treatment

22 October 2020 - U.S. Prescribing Information updated to include PSO-LONG clinical trial data concerning long-term use (52 weeks) of twice-weekly ...

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Trixeo Aerosphere recommended for approval in the EU by CHMP for the maintenance treatment of COPD

19 October 2020 - Recommendation of triple-combination therapy based on positive results from ETHOS and KRONOS Phase III trials ...

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Heron Therapeutics receives European Commission authorisation for Zynrelef (HTX-011) for the treatment of post-operative pain

28 September 2020 - Heron Therapeutics today announced that the European Commission has granted a marketing authorisation for Zynrelef (formerly known ...

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ICER issues final report and policy recommendations on treatments for cystic fibrosis

23 September 2020 -  Independent appraisal committee unanimously concludes that Trikafta delivers substantial benefits for patients, family members, and society. ...

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Knight and TherapeuticsMD announce Health Canada approval of Bijuva

21 September 2020 -  Knight Therapeutics and TherapeuticsMD announced today the approval of Bijuva (estradiol and progesterone) capsules by Health ...

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Decision to fund an additional brand of budesonide with eformoterol

18 September 2020 - PHARMAC is pleased to announce a decision to fund an additional brand of budesonide with eformoterol ...

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Vertex announces European Medicines Agency type II variation marketing authorisation application validation for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor in people with one copy of the F508del mutation

14 September 2020 - Vertex Pharmaceuticals today announced the EMA has validated a type II variation marketing authorisation application for ...

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