Allergan receives FDA qualified infectious disease product designation and fast track designation for ATM-AVI (aztreonam and avibactam) for antibiotic-resistant gram-negative infections

11 November 2019 - FDA QIDP and fast track designations signify significant milestones in Allergan commitment to addressing unmet medical needs ...

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RedHill Biopharma announces FDA approval of Talicia for treatment of H. pylori in adults

4 November 2019 - RedHill plans to launch Talicia in the U.S. in Q1/2020 for the treatment of H. pylori infection ...

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Vertex announces EMA marketing authorisation application validation for VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination treatment in cystic fibrosis

31 October 2019 - Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages ...

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Heron Therapeutics announces FDA acceptance of new drug application resubmission for HTX-011 for management of post-operative pain

28 October 2019 - FDA sets prescription drug user fee act goal date of 26 March 2020. ...

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Knight Therapeutics and SIFI announce approval of Netildex in Canada

23 October 2019 - Knight Therapeutics and SIFI today announced that Health Canada has approved Netildex for the treatment of inflammatory ...

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Vertex prices cystic fibrosis combo treatment at $311,000-per-year

22 October 2019 - Vertex Pharmaceuticals has priced its three-drug combination for cystic fibrosis (CF) at $311,503 per year, after winning ...

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ViiV Healthcare submits supplemental new drug application to US FDA for use of Dovato in virologically suppressed adults with HIV-1

16 October 2019 - ViiV Healthcare announced the submission of a supplemental New Drug Application to the US FDA for ...

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HIV prevention drugs will be available without a prescription in California

7 October 2019 - California will expand access to HIV prevention drugs by allowing pharmacies to offer the medications without ...

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Vivus announces acceptance of Qsymia decentralised marketing authorisation application in Europe

7 October 2019 - Vivus announced today that European regulatory agencies in Sweden, Denmark, Finland, Iceland, Norway, and Poland have ...

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FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic

3 October 2019 - The U.S. FDA today approved Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) in at-risk ...

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Novartis Entresto receives FDA approval for paediatric heart failure, helping to address critical unmet need for treatment options

1 October 2019 - Entresto is now approved for the treatment of paediatric patients aged 1 year and older with symptomatic ...

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AstraZeneca provides an update on US regulatory review of PT010 in COPD

1 October 2019 - AstraZeneca today announced that the US FDA has issued a complete response letter regarding the new ...

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Gilead wins $6 million deal to distribute HIV drug it donated

28 September 2019 - 4,250 uninsured patients expected to get PrEP for free in next six months. ...

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FDA approves treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis that shortens duration of treatment to eight weeks

26 September 2019 - The U.S. FDA today expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight week ...

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Merck’s Pifelto (doravirine) and Delstigo (doravirine/lamivudine/tenofovir disoproxil fumarate) receive US FDA approval for use in appropriate adults living with HIV-1 who are virologically suppressed

20 September 2019 - Approvals based on findings from the Phase 3 DRIVE-SHIFT Trial evaluating a switch to Delstrigo. ...

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