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RSS FeedPosted by Michael Wonder on 02 Sep 2022
Azurity Pharmaceuticals announces FDA approval of Konvomep (omeprazole and sodium bicarbonate for oral suspension)
2 September 2022 - Azurity Pharmaceuticals announced today that the US FDA has approved Konvomep (omeprazole and sodium bicarbonate for oral ...
Posted by Michael Wonder on 31 Aug 2022
Amneal announces submission of new drug application to the US FDA for IPX203 for the treatment of Parkinson’s disease
31 August 2022 - IPX203 is a novel, extended-release oral formulation of carbidopa and levodopa that if approved, would offer patients ...
Posted by Michael Wonder on 23 Aug 2022
European Medicines Agency commences review of oral fixed-dose combination of decitabine and cedazuridine for the treatment of adults with acute myeloid leukaemia
22 August 2022 - Otsuka and Astex Pharmaceuticals today announce that the EMA has accepted the marketing authorisation application for the ...
Posted by Michael Wonder on 20 Aug 2022
Axsome Therapeutics announces FDA approval of Auvelity, the first and only oral NMDA receptor antagonist for the treatment of major depressive disorder in adults
19 August 2022 - Auvelity is the first and only rapid-acting oral treatment approved with labelling of statistically significant improvement in ...
Posted by Michael Wonder on 07 Aug 2022
Myovant Sciences and Pfizer receive U.S. FDA approval of Myfembree, a once daily treatment for the management of moderate to severe pain associated with endometriosis
5 August 2022 - Data from the Phase 3 SPIRIT program showed Myfembree reduced menstrual pain and non-menstrual pelvic pain in ...
Posted by Michael Wonder on 30 Jun 2022
Pfizer announces submission of new drug application to the U.S. FDA for Paxlovid
30 June 2022 - Final results from EPIC-HR study showed an 86% reduction in relative risk of hospitalisations or death from ...
Posted by Michael Wonder on 23 Jun 2022
Maviret (glecaprevir/pibrentasvir) approved by Health Canada for paediatric patients with chronic hepatitis C
22 June 2022 - This approval is supported by 98.4 per cent cure rate across this group of patients who ...
Posted by Michael Wonder on 15 Jun 2022
TGA approves Vyxeos
15 June 2022 - This marks the first TGA approval for Jazz Pharmaceuticals. ...
Posted by Michael Wonder on 13 Jun 2022
Amylyx Pharmaceuticals announces Health Canada approval of Albrioza for the treatment of ALS
13 June 2022 - Health Canada decision signifies the first global regulatory approval for Amylyx and the first new therapy for ...
Posted by Michael Wonder on 04 Jun 2022
Amylyx Pharmaceuticals receives notification of PDUFA date extension for AMX0035 for the treatment of ALS
3 June 2022 - New PDUFA goal date scheduled for 29 September 2022 to allow time to review additional data ...
Posted by Michael Wonder on 26 May 2022
Pfizer granted FDA fast track designation for ervogastat/clesacostat combination for the treatment of non-alcoholic steatohepatitis
26 May 2022 - Pfizer today announced the U.S. FDA has granted fast track designation to Pfizer’s investigational combination therapy ...
Posted by Michael Wonder on 20 May 2022
AbbVie submits new drug application to U.S. FDA for investigational ABBV-951 (foscarbidopa/foslevodopa) for the treatment of advanced Parkinson's disease
20 May 2022 - Submission is supported by Phase 3 study that demonstrated patients had significant increases in hours of ...
Posted by Michael Wonder on 04 May 2022
Phathom Pharmaceuticals announces FDA approval of Voquenza Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquenza Dual Pak (vonoprazan, amoxicillin) for the treatment of H. pylori infection in adults
3 May 2022 - U.S. commercial launch anticipated in the third quarter of 2022. ...
Posted by Michael Wonder on 20 Apr 2022
Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 years with at least one F508del mutation
20 April 2022 - Vertex has submitted this indication to CADTH & INESSS for health technology assessments. ...
Posted by Michael Wonder on 15 Apr 2022
Evusheld receives Health Canada approval for pre-exposure prophylaxis (prevention) of COVID-19 in immune-compromised individuals
14 April 2022 - Evusheld is the first long-acting antibody combination to receive Health Canada authorisation for the prevention of ...