Blog
RSS FeedPosted by Michael Wonder on 31 May 2020
FDA approves the first oral medication for the management of heavy menstrual bleeding due to uterine fibroids in pre-menopausal women
29 May 2020 - Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) is expected to be available in the U.S. ...
Posted by Michael Wonder on 23 May 2020
U.S. FDA approves Evofem Biosciences' Phexxi (lactic acid, citric acid and potassium bitartrate), the first and only non-hormonal prescription gel for the prevention of pregnancy
22 May 2020 - A new class of female-controlled birth control for use in-the-moment. ...
Posted by Michael Wonder on 21 May 2020
Mithra and Searchlight Pharma announce filing of new drug submission for Estelle in Canada
20 May 2020 - Searchlight Pharma's new drug submission for a novel combined oral contraceptive accepted for review by Health Canada. ...
Posted by Michael Wonder on 19 May 2020
Bevespi Aerosphere approved in China for patients with COPD
18 May 2020 - First approval in China of a fixed-dose, long-acting dual bronchodilator in a pressurised metered-dose inhaler device. ...
Posted by Michael Wonder on 01 May 2020
Novartis receives CHMP positive opinion for Enerzair Breezhaler (QVM149), a potential first-in-class inhaled LABA/LAMA/ICS combination for uncontrolled asthma
1 May 2020 - Digital companion with app and sensor that provide inhalation confirmation, medication reminders and access to objective data ...
Posted by Michael Wonder on 16 Apr 2020
Mayne Pharma submits new drug application for E4/DRSP to the FDA
16 April 2020 - Mayne Pharma and Mithra Pharmaceuticals today announced that Mayne Pharma has submitted a new drug application ...
Posted by Michael Wonder on 13 Apr 2020
Gilead Canada submits supplemental new drug submission to Health Canada for Descovy for HIV pre-exposure prophylaxis
9 April 2020 - Submission supported by data from the DISCOVER trial, which evaluated the safety and efficacy of Descovy compared ...
Posted 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
COVID-19: sacubitril with valsartan (Entresto)
25 March 2020 - Sacubitril with valsartan is a medicine used in the management of clinically significant, treatment refractory heart ...
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 16 Mar 2020
HIV drug PrEP to be available across England
15 March 2020 - PrEP will be routinely available across England as part of the government’s aim to end HIV transmission ...
Posted by Michael Wonder on 10 Mar 2020
Decision to fund betamethasone dipropionate with calcipotriol (Enstilar) foam spray for psoriasis
10 March 2020 - PHARMAC is pleased to announce the approval of a decision to fund a new topical psoriasis ...
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. ...