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. ...

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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. ...

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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. ...

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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. ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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, ...

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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. ...

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