Blog
RSS FeedPosted by Michael Wonder on 08 Apr 2020
Esperion Announces European Commission approval of the Nustendi (bempedoic acid and ezetimibe) tablet for the treatment of hypercholesterolaemia and mixed dyslipidaemia
6 April 2020 - First non-statin, LDL-C lowering combination medicine ever approved in Europe. ...
Posted by Michael Wonder on 24 Mar 2020
Helsinn announces European approval of the IV formulation of Akynzeo (fosnetupitant with palonosetron)
23 March 2020 - Helsinn today announces that the European Commission has approved the intravenous formulation of Akynzeo, (a fixed ...
Posted by Michael Wonder on 21 Mar 2020
Janssen announces Health Canada approval of Cabenuva, the first long-acting regimen for the treatment of HIV
20 March 2020 - Cabenuva offers adults living with HIV a new once-monthly injectable option for maintaining viral suppression. ...
Posted by Michael Wonder on 29 Feb 2020
GSK filing accepted by European Medicines Agency for Trelegy Ellipta use in adult patients with asthma
27 February 2020 - Submission supported by pivotal CAPTAIN study demonstrating statistically significant improvement in lung function compared with the ICS/LABA, ...
Posted by Michael Wonder on 28 Feb 2020
Nuvo Pharmaceuticals announces Health Canada approves Suvexx for the acute treatment of migraine
27 February 2020 - Canadian launch anticipated in the second half of 2020. ...
Posted by Michael Wonder on 20 Feb 2020
Heron Therapeutics announces FDA extension of review period for NDA for HTX-011 for the management of post-operative pain
19 February 2020 - Updated Prescription Drug User Fee Act goal date is 26 June 2020. ...
Posted by Michael Wonder on 15 Feb 2020
FDA approves Agile Therapeutics' Twirla (levonorgestrel and ethinyl estradiol) transdermal system – a new weekly contraceptive patch delivering a 30 mcg daily dose of oestrogen and 120 mcg daily dose of progestin
14 February 2020 - Twirla is a new non-daily, non-invasive contraceptive approved in the U.S. ...
Posted by Michael Wonder on 04 Feb 2020
FDA accepts for review supplemental new drug application for Recarbrio (imipenem, cilastatin, and relebactam) for the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia
3 February 2020 - Filing receives priority review. ...
Posted by Michael Wonder on 03 Feb 2020
Esperion announces positive CHMP opinion for the marketing authorisation application for bempedoic acid for the treatment of hypercholesterolaemia and mixed dyslipidaemia
31 January 2020 - Positive CHMP opinion is based on the completed pivotal Phase 3 LDL-cholesterol lowering program. ...
Posted by Michael Wonder on 03 Jan 2020
Aerie Pharmaceuticals announces acceptance for review of the Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% marketing authorisation application in Europe
2 January 2020 - Aerie Pharmaceuticals today announced that the EMA has accepted for review the marketing authorisation application for Roclanda ...
Posted by Michael Wonder on 22 Dec 2019
ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV
21 December 2019 - ViiV Healthcare, with Pfizer and Shionogi, has received a complete response letter from the US FDA regarding ...
Posted by Michael Wonder on 04 Dec 2019
Health Canada grants priority review status for Heron Therapeutics' new drug submission for HTX-011 for management of post-operative pain
3 December 2019 - Heron Therapeutics today announced that Heron's new drug submission for HTX-011 for the management of postoperative pain ...
Posted by Michael Wonder on 04 Dec 2019
Aerie Pharmaceuticals submits marketing authorisation application for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% in Europe
3 December 2019 - Aerie Pharmaceuticals today announced that it has submitted the marketing authorisation application for Roclanda (netarsudil and latanoprost ...
Posted by Michael Wonder on 28 Nov 2019
Hikma completes its FDA response for generic Advair
27 November 2019 - Hikma Pharmaceuticals today announces that it has submitted to the US FDA its response to deficiencies in ...
Posted by Michael Wonder on 22 Nov 2019
Health Canada approves Lonsurf (trifluridine/tipiracil) for adults with metastatic gastric cancer during stomach cancer awareness month
21 November 2019 - New indication improves overall survival for end stage metastatic disease ...