Cystic fibrosis drug campaign makes no progress in year

10 May 2019 - It is a year on from the delivery of more than 1,000 letters to Downing Street, ...

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A million Americans need this drug. Trump’s deal won’t help enough of them.

13 May 2019 - A donation of HIV prevention drugs from the pharmaceutical giant Gilead could benefit shareholders more than patients. ...

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RedHill Biopharma submits new drug application for Talicia for H. pylori Infection

7 May 2019 - RedHill Biopharma today announced that, following a positive pre-NDA meeting held recently with the U.S. FDA, ...

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Esperion announces U.S. FDA acceptance of new drug applications for both bempedoic acid and the bempedoic acid with ezetimibe combination tablet for filing and regulatory review

5 May 2019 - 21 February 2020 PDUFA target date goal for bempedoic acid and 26 February 2020 PDUFA target ...

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Qternmet XR approved in the US for the treatment of type 2 diabetes

3 May 2019 - The US FDA has approved Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) extended release tablets as ...

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Heron Therapeutics receives complete response letter for HTX-011 for the management of post-operative pain

1 May 2019 - Complete response letter requests additional chemistry manufacturing and controls and non-clinical information. ...

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FDA approves first treatment for all genotypes of hepatitis C in paediatric patients

30 April 2019 - The U.S. FDA today approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of ...

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Janssen announces submission of new drug application to U.S. FDA for the first monthly, injectable, two drug regimen of rilpivirine and cabotegravir for treatment of HIV

29 April 2019 - If approved, the rilpivirine and cabotegravir regimen would be the first-ever long-acting injectable treatment for adults living ...

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ViiV Healthcare announces CHMP positive opinion for Dovato (dolutegravir/lamivudine) as a once-daily, single-pill, two-drug regimen for the treatment of HIV infection

26 Apri 2019 - Recommendation based on landmark GEMINI 1 & 2 studies which demonstrated non-inferior efficacy of dolutegravir + lamivudine ...

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FDA approves Bausch Health's Duobrii (halobetasol propionate and tazarotene) lotion 0.01%/0.045% for plaque psoriasis in adults

25 April 2019 - First and only topical lotion combining halobetasol propionate and tazarotene in one formulation. ...

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US FDA approves Duaklir Pressair (aclidinium/formoterol) for patients with chronic obstructive pulmonary disease

17 April 2019 - Only twice-daily LAMA /LABA in the United States with COPD exacerbation data included in its prescribing information. ...

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Cystic Fibrosis scandal: MP demands answers on delay of vital NHS drugs deal

11 April 2019 - Theresa May yesterday vowed to take action over the lack of an NHS deal for cystic fibrosis ...

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Gilead submits supplemental new drug application to U.S. FDA for once daily Descovy for HIV pre-exposure prophylaxis

5 April 2019 - Filing supported by data demonstrating non-inferiority compared to Truvada coupled with bone and renal safety advantages in ...

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HIRA puts brakes on Gilead’s AIDS treatment receiving reimbursement

22 March 2019 - The reimbursement plan for Gilead Science Korea’s Biktarvy, an acquired immune deficiency syndrome (AIDS) treatment, has been ...

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Aerie Pharmaceuticals announces U.S. FDA approval of Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% for the reduction of intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension

12 March 2019 - Aerie Pharmaceuticals today announced that the U.S. FDA has approved Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% ...

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