Blog
RSS FeedPosted 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 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 11 Jan 2023
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 ...
Posted by Michael Wonder on 22 Dec 2022
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 ...
Posted by Michael Wonder on 01 Dec 2022
Innoviva announces FDA acceptance and priority review of new drug application for sulbactam-durlobactam
30 November 2022 - Sulbactam-durlobactam is a targeted antibiotic that was specifically designed to treat serious infections caused by Acinetobacter baumannii, ...
Posted by Michael Wonder on 04 Oct 2022
Newly approved ALS drug Relyvrio to face its next challenge: pricing and reimbursement
4 October 2022 - There’s a swirl of controversy surrounding last week’s regulatory approval of Relyvrio (sodium phenylbutyrate and taurursodiol), which ...
Posted by Michael Wonder on 29 Sep 2022
FDA approves new treatment option for patients with ALS
29 September 2022 - The US FDA today approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis, commonly ...
Posted by Michael Wonder on 02 Sep 2022
Vertex announces U.S. FDA approval for Orkambi (lumacaftor/ivacaftor) in children with cystic fibrosis ages 12 to <24 months
2 September 2022 - With this approval, approximately 300 children with two copies of the F508del mutation will have a ...
Posted 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 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 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 ...