Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 20 Aug 2019
FDA accepts new drug application for VX-445 (elexacaftor), tezacaftor and ivacaftor combination treatment
20 August 2019 - FDA grants priority review of the application and sets a PDUFA target action date of 19 ...
Posted by Michael Wonder on 23 Jul 2019
FDA reinforces need for applicants to submit thorough and timely safety information for combination medical products
22 July 2019 - Today, the U.S. FDA released a final guidance, “Post-marketing Safety Reporting for Combination Products,” for applicants ...
Posted by Michael Wonder on 22 Jul 2019
Vertex submits new drug application to the U.S. FDA for triple combination regimen of VX-445 (elexacaftor), tezacaftor and ivacaftor in cystic fibrosis
22 July 2019 - Application supported by positive results from two global Phase 3 studies in people with CF ages 12 ...
Posted by Michael Wonder on 15 Jul 2019
Teva announces FDA approval of AirDuo Digihaler (fluticasone propionate 113 mcg and salmeterol 14 mcg) inhalation powder
15 July 2019 - The first digital maintenance asthma inhaler therapy with integrated sensors joins Teva’s digital rescue inhaler therapy to ...
Posted by Michael Wonder on 09 Jul 2019
ViiV Healthcare announces start of first-ever study to identify and evaluate approaches to implementing its once-monthly injectable HIV treatment in clinical practice
9 July 2019 - The long-acting injectable regimen has been granted priority review status by the FDA, with a target approval ...
Posted by Michael Wonder on 23 Jun 2019
FDA issues complete response letter for Ryaltris (olopatadine hydrochloride and mometasone furoate)
22 June 2019 - We would like to inform you that the U.S. FDA has issued a complete response letter ...
Posted by Michael Wonder on 21 Jun 2019
FDA expands approval of treatment for cystic fibrosis to include patients ages 6 and older
21 June 2019 - The U.S. FDA today expanded the indication for Symdeko (a combination of tezacaftor/ivacaftor) tablets for treatment of ...
Posted by Michael Wonder on 04 Jun 2019
U.S. FDA accepts new drug application for triple combination tablet for adults with type 2 diabetes
4 June 2019 - The U.S. FDA has accepted the new drug application for the investigational fixed-dose combination tablet of empagliflozin, ...
Posted by Michael Wonder on 03 Jun 2019
FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia
3 June 2019 - The U.S. FDA today approved a new indication for the previously FDA approved drug, Zerbaxa (ceftolozane and ...
Posted by Michael Wonder on 03 Jun 2019
Galt Pharmaceuticals answers the call for better practices in pain management with a non-opioid therapeutic alternative
29 May 2019 - Officials with the FDA have given priority review designation to an opioid-free pain management treatment from ...