Vertex announces Health Canada market authorisation for Orkambi (lumacaftor/ivacaftor) in children with cystic fibrosis ages 1 to <2 years

10 April 2023 - With this approval, approximately 30 children with two copies of the F508del mutation are eligible for ...

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‘An absolute game changer’: children under 12 to receive life saving drug

6 April 2023 - Hundreds of children with cystic fibrosis will have subsidised access to the life-changing medication Trikafta from ...

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AbbVie provides regulatory update on ABBV-951 (foscarbidopa/foslevodopa) new drug application

22 March 2023 - AbbVie today announced it received a complete response letter from the US FDA for the new ...

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Maxigesic Rapid tablets gain US FDA approval

10 March 2023 - AFT Pharmaceuticals today announces the US FDA has approved a rapid release tablet form of Maxigesic ...

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Jazz Pharmaceuticals secures eight additional provincial reimbursements for Vyxeos for treatment of adults with newly diagnosed therapy-related acute myeloid leukaemia or acute myeloid leukaemia with myelodysplasia-related changes

8 March 2023 - Jazz Pharmaceuticals announced today that Vyxeos (daunorubicin and cytarabine liposome for injection) is now included on eight ...

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PHARMAC announces decision to fund Trikafta

7 March 2023 - Pharmac has today confirmed the funding of elexacaftor with tezacaftor and ivacaftor (Trikafta) for people with cystic ...

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Janssen submits new drug application to the US FDA seeking approval of niraparib and abiraterone acetate dual action tablet, plus prednisone, as a first-line targeted treatment for patients with metastatic castration-resistant prostate cancer with BRCA gene mutations

28 February 2023 - Niraparib and abiraterone acetate plus prednisone has potential to address unmet need for patients with BRCA ...

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ViiV Healthcare receives EU marketing authorisation for Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once daily treatment for Children living with HIV in Europe

23 February 2023 - The authorisation is an important step to meet ViiV Healthcare’s commitment to bring paediatric formulations to children ...

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Miracle’ cystic fibrosis drug kept out of reach in developing countries

7 February 2023 - Vertex Pharmaceuticals is not making its drug, Trikafta, available in poorer countries, where thousands of diagnosed patients ...

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Zai Lab announces NDA for sulbactam-durlobactam granted priority review by China’s NMPA

30 January 2023 - Zai Lab today announced that the Center for Drug Evaluation of China’s National Medical Products Administration has ...

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Pfizer receives positive CHMP opinion for conversion of Paxlovid conditional marketing authorisation to full marketing authorisation in the European Union

27 January 2023 - Pfizer today announced that the CHMP of the EMA has recommended converting the conditional marketing authorisation ...

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First and only rescue medication approved in the US for as needed use to reduce risk of asthma exacerbations

11 January 2023 - Airsupra (albuterol/budesonide), formerly known as PT027, has been approved in the US for the as needed ...

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US FDA extends review of Pfizer’s new drug application for Paxlovid

20 December 2022 - Pfizer oral treatment remains available to eligible US patients under emergency use authorisation as a critical ...

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Trifluridine with tipiracil hydrochloride for the treatment of patients with metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma after two or more treatments

14 December 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...

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PHARMAC seeking feedback on funding Trikafta

4 December 2022 - PHARMAC has reached a provisional agreement with medicine supplier Vertex to fund Trikafta. ...

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