Blog
RSS FeedPosted by Michael Wonder on 07 Jul 2020
Novartis receives EC approval for Enerzair Breezhaler, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU
7 July 2020 - Optional digital companion with sensor and app that provide inhalation confirmation, medication reminders and access to objective ...
Posted by Michael Wonder on 30 Jun 2020
Heron Therapeutics receives complete response letter for HTX-011 for the management of post-operative pain
29 June 2020 - Complete response letter requests additional non-clinical information. ...
Posted by Michael Wonder on 29 Jun 2020
New medicine for cystic fibrosis patients
26 June 2020 - EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Kaftrio, ...
Posted by Michael Wonder on 24 Jun 2020
Mayne Pharma announces FDA filing acceptance of new drug application for E4/DRSP in the US
24 June 2020 - Mayne Pharma is pleased to announce the new drug application for E4/DRSP to prevent pregnancy has been ...
Posted by Michael Wonder on 19 Jun 2020
Cancer Prevention Pharmaceuticals submits EU marketing authorisation application for CPP-1X/sul for treatment of familial adenomatous polyposis
18 June 2020 - Cancer Prevention Pharmaceuticals announced today that it has submitted a marketing authorisation application to the European Medicines ...
Posted by Michael Wonder on 12 Jun 2020
Health Canada issues notice of compliance for Bausch Health's Duobrii
11 June 2020 - Topical combination improving the sings and symptoms of plaque psoriasis in adult patients with moderate to ...
Posted by Michael Wonder on 04 Jun 2020
FDA approves antibiotic to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
4 June 2020 - Today, the U.S. Food and Drug Administration approved Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat ...
Posted by Michael Wonder on 03 Jun 2020
Helsinn Group announces FDA approval of a new liquid formulation of Akynzeo (fosnetupitant/palonosetron) injection in the United States
2 June 2020 - Helsinn today announces that the U.S. FDA has approved the ready-to-dilute liquid formulation of Akynzeo (fosnetupitant/palonosetron) ...
Posted by Michael Wonder on 02 Jun 2020
Sumitovant Biopharma announces Myovant Sciences' submission of new drug application to the FDA for once daily relugolix combination tablet for the treatment of women with uterine fibroids
1 June 2020 - Sumitovant Biopharma announced today that Myovant Sciences has submitted a new drug application to the U.S. FDA ...
Posted 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 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 ...