Blog
RSS FeedPosted by Michael Wonder on 09 Apr 2024
ViiV Healthcare announces US FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV
8 April 2024 - Dovato is now the first and only oral, two drug, single-tablet regimen available for people aged 12 ...
Posted by Michael Wonder on 25 Mar 2024
US FDA approves Opsynvi (macitentan and tadalafil) as the first and only once daily single tablet combination therapy for patients with pulmonary arterial hypertension
22 March 2024 - Approval is based on the results from the pivotal Phase 3 A DUE study, which met ...
Posted by Michael Wonder on 24 Feb 2024
Venatorx and Melinta provide update on status of US new drug application for cefepime-taniborbactam
23 February 2024 - No clinical safety or efficacy issues identified. ...
Posted by Michael Wonder on 29 Nov 2023
Karuna Therapeutics announces US FDA accepts new drug application for KarXT for the treatment of schizophrenia
29 November 2023 - PDUFA action date is 26 September 2024. ...
Posted by Michael Wonder on 08 Nov 2023
Zydus receives US FDA approval for Zituvimet to treat adult patients with type 2 diabetes mellitus
6 November 2023 - The company received final approval from the US FDA for its new drug application for Zituvimet ...
Posted by Michael Wonder on 23 Oct 2023
FDA approves Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) topical gel for the treatment of acne vulgaris in patients twelve years of age and older
20 October 2023 - First and only FDA approved fixed dose, triple combination topical treatment. ...
Posted by Michael Wonder on 15 Aug 2023
Venatorx Pharmaceuticals announces FDA acceptance and priority review of new drug application for cefepime-taniborbactam to treat complicated urinary tract infections, including pyelonephritis, in adults
15 August 2023 - PDUFA action date set for 22 February 2024. ...
Posted by Michael Wonder on 11 Aug 2023
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA mutated metastatic castration-resistant prostate cancer
11 August 2023 - Today, the FDA approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech), ...
Posted by Michael Wonder on 02 Aug 2023
FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancer
2 August 2023 - Today, the FDA approved trifluridine and tipiracil (Lonsurf, Taiho Oncology) with bevacizumab, for metastatic colorectal cancer ...
Posted by Michael Wonder on 27 Jun 2023
Allecra Therapeutics submits new drug application to the US FDA for Exblifep for the treatment of complicated urinary tract infections
27 June 2023 - Allecra Therapeutics announced today the submission of a new drug application to the US FDA for ...
Posted 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 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 ...