Blog
RSS FeedPosted by Michael Wonder on 13 Nov 2019
Allergan receives FDA qualified infectious disease product designation and fast track designation for ATM-AVI (aztreonam and avibactam) for antibiotic-resistant gram-negative infections
11 November 2019 - FDA QIDP and fast track designations signify significant milestones in Allergan commitment to addressing unmet medical needs ...
Posted by Michael Wonder on 05 Nov 2019
RedHill Biopharma announces FDA approval of Talicia for treatment of H. pylori in adults
4 November 2019 - RedHill plans to launch Talicia in the U.S. in Q1/2020 for the treatment of H. pylori infection ...
Posted by Michael Wonder on 01 Nov 2019
Vertex announces EMA marketing authorisation application validation for VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination treatment in cystic fibrosis
31 October 2019 - Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages ...
Posted by Michael Wonder on 28 Oct 2019
Heron Therapeutics announces FDA acceptance of new drug application resubmission for HTX-011 for management of post-operative pain
28 October 2019 - FDA sets prescription drug user fee act goal date of 26 March 2020. ...
Posted by Michael Wonder on 24 Oct 2019
Knight Therapeutics and SIFI announce approval of Netildex in Canada
23 October 2019 - Knight Therapeutics and SIFI today announced that Health Canada has approved Netildex for the treatment of inflammatory ...
Posted by Michael Wonder on 23 Oct 2019
Vertex prices cystic fibrosis combo treatment at $311,000-per-year
22 October 2019 - Vertex Pharmaceuticals has priced its three-drug combination for cystic fibrosis (CF) at $311,503 per year, after winning ...
Posted by Michael Wonder on 16 Oct 2019
ViiV Healthcare submits supplemental new drug application to US FDA for use of Dovato in virologically suppressed adults with HIV-1
16 October 2019 - ViiV Healthcare announced the submission of a supplemental New Drug Application to the US FDA for ...
Posted by Michael Wonder on 08 Oct 2019
HIV prevention drugs will be available without a prescription in California
7 October 2019 - California will expand access to HIV prevention drugs by allowing pharmacies to offer the medications without ...
Posted by Michael Wonder on 08 Oct 2019
Vivus announces acceptance of Qsymia decentralised marketing authorisation application in Europe
7 October 2019 - Vivus announced today that European regulatory agencies in Sweden, Denmark, Finland, Iceland, Norway, and Poland have ...
Posted by Michael Wonder on 03 Oct 2019
FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic
3 October 2019 - The U.S. FDA today approved Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) in at-risk ...
Posted by Michael Wonder on 03 Oct 2019
Novartis Entresto receives FDA approval for paediatric heart failure, helping to address critical unmet need for treatment options
1 October 2019 - Entresto is now approved for the treatment of paediatric patients aged 1 year and older with symptomatic ...
Posted by Michael Wonder on 01 Oct 2019
AstraZeneca provides an update on US regulatory review of PT010 in COPD
1 October 2019 - AstraZeneca today announced that the US FDA has issued a complete response letter regarding the new ...
Posted by Michael Wonder on 30 Sep 2019
Gilead wins $6 million deal to distribute HIV drug it donated
28 September 2019 - 4,250 uninsured patients expected to get PrEP for free in next six months. ...
Posted by Michael Wonder on 26 Sep 2019
FDA approves treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis that shortens duration of treatment to eight weeks
26 September 2019 - The U.S. FDA today expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight week ...
Posted by Michael Wonder on 22 Sep 2019
Merck’s Pifelto (doravirine) and Delstigo (doravirine/lamivudine/tenofovir disoproxil fumarate) receive US FDA approval for use in appropriate adults living with HIV-1 who are virologically suppressed
20 September 2019 - Approvals based on findings from the Phase 3 DRIVE-SHIFT Trial evaluating a switch to Delstrigo. ...