Blog
RSS FeedPosted by Michael Wonder on 30 May 2023
Janssen submits new drug application to US FDA seeking approval of investigational single tablet combination therapy of macitentan and tadalafil for treatment of patients with pulmonary arterial hypertension
30 May 2023 - This is the first and only single tablet combination therapy application to be submitted for review in ...
Posted by Michael Wonder on 25 May 2023
FDA approves first oral anti-viral for treatment of COVID-19 in adults
25 May 2023 - Today, the US FDA approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral ...
Posted by Michael Wonder on 23 May 2023
FDA approves new treatment for pneumonia caused by certain difficult to treat bacteria
23 May 2023 - Today, the US FDA approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired ...
Posted by Michael Wonder on 09 May 2023
Nirmatrelvir and ritonavir for treating COVID-19
4 May 2023 - NICE is conducting a partial rapid review of TA878. ...
Posted by Michael Wonder on 13 Apr 2023
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 ...
Posted by Michael Wonder on 05 Apr 2023
‘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 ...
Posted by Michael Wonder on 23 Mar 2023
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 ...
Posted by Michael Wonder on 11 Mar 2023
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 ...
Posted by Michael Wonder on 08 Mar 2023
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 ...
Posted by Michael Wonder on 07 Mar 2023
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 ...
Posted by Michael Wonder on 01 Mar 2023
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 ...
Posted by Michael Wonder on 24 Feb 2023
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 ...
Posted by Michael Wonder on 07 Feb 2023
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 ...
Posted by Michael Wonder on 03 Feb 2023
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 ...
Posted by Michael Wonder on 29 Jan 2023
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 ...