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RSS FeedPosted by Michael Wonder on 18 Jun 2021
Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in people ages 12 and older who have at least one F508del mutation
18 June 2021 - Approximately 1,100 F/MF patients now eligible for a CFTR modulator to treat the underlying cause of their ...
Posted by Michael Wonder on 11 Jun 2021
U.S. FDA approves new formulation of Epclusa, expanding paediatric indication to treat children ages 3 and older with chronic hepatitis C
10 June 2021 - Gilead Sciences announced today that the U.S. FDA has approved an expansion of the pediatric indication of ...
Posted by Michael Wonder on 09 Jun 2021
Vertex announces U.S. FDA approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 with certain mutations
9 June 2021 - With this approval approximately 1,500 children with one minimal function mutation and one F508del mutation have a ...
Posted by Michael Wonder on 01 Jun 2021
Lannett announces FDA acceptance, as a priority original ANDA, of the generic Advair Diskus filing
1 June 2021 - Lannett today announced the U.S. FDA has accepted the abbreviated new drug application for fluticasone propionate and ...
Posted by Michael Wonder on 01 Jun 2021
Alkermes announces FDA approval of Lybalvi for the treatment of schizophrenia and bipolar I disorder
1 June 2021 - Commercial launch planned for fourth quarter 2021. ...
Posted by Michael Wonder on 24 May 2021
Positive CHMP opinion for Ryeqo (relugolix combination tablet)
21 May 2021 - Gedeon Richter announces that the CHMP of the EMA has adopted a positive opinion recommending approval of ...
Posted by Michael Wonder on 20 May 2021
EMA, MHRA to review Vertex' Kaftrio for children with cystic fibrosis
20 May 2021 - The EMA and the MHRA have validated Vertex' applications to expand the scope of its cystic ...
Posted by Michael Wonder on 17 May 2021
New Zealanders living with cystic fibrosis wait for 'life changing' drug
16 May 2021 - Edward Lee and Reese Robertson both have cystic fibrosis. ...
Posted by Michael Wonder on 13 May 2021
Heron Therapeutics announces U.S. FDA approval of Zynrelef for the management of post-operative pain for up to 72 hours
13 May 2021 - Full U.S. commercial launch of Zynrelef is planned for July 2021. ...
Posted by Michael Wonder on 11 May 2021
MHRA approves label extension for Vertex’s Kaftrio combo
11 May 2021 - The UK MHRA has approved a label extension for Vertex’s cystic fibrosis treatment Kaftrio in combination ...
Posted by Michael Wonder on 09 May 2021
Families plead for PBS listing for ‘life-saving’ cystic fibrosis drug
8 May 2021 - A new drug is being hailed as a “game-changer” for cystic fibrosis sufferers as the government is ...
Posted by Michael Wonder on 25 Apr 2021
The price of a Vertex cystic fibrosis treatment stirs anger in Australia
23 April 2021 - The latest dustup over the cost of cystic fibrosis medicines sold by Vertex Pharmaceuticals is taking ...
Posted by Michael Wonder on 20 Apr 2021
Aerie Pharmaceuticals receives marketing authorisation of Roclanda 50 mcg/mL + 200 mcg/mL solution eye drops (latanoprost + netarsudil) in Great Britain
19 April 2021 - Aerie Pharmaceuticals today announced that Roclanda 50 mcg/mL + 200 mcg/mL solution eye drops (latanoprost + netarsudil) ...
Posted by Michael Wonder on 16 Apr 2021
Mayne Pharma and Mithra announce FDA approval of new oral contraceptive Estelle
15 April 2021 - Mayne Pharma Group and Mithra Pharmaceuticals are very pleased to announce that the US FDA has approved ...
Posted by Michael Wonder on 12 Apr 2021
Jazz Pharmaceuticals announces FDA acceptance and priority review of supplemental new drug application for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in idiopathic hypersomnia
12 April 2021 - Final FDA decision anticipated by 12 August. ...