FDA approves first treatment for COVID-19

22 October 2020 - Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult ...

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Nexplanon recommended after second submission

22 October 2020 - The first submission was withdrawn. ...

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Will HIRA resume talk to grant benefits for anti-diabetic combo drugs?

22 October 2020 - Three makers of SGLT-2 inhibiting anti-diabetic drugs said they would seek changes in approval conditions to ...

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CADTH in favour of new indication for Soliris

22 October 2020 - CADTH has finalised its assessment of eculizumab for adult patients with refractory generalised myasthenia gravis. ...

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PHARMAC decision pending on life-changing diabetes medications

22 October 2020 - Government drug-funding agency PHARMAC is expected to decide next week whether it will fund two new ...

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Leo Pharma announces U.S. FDA approval for Enstilar (calcipotriene and betamethasone dipropionate) foam U.S. Prescribing Information update to include data in long-term use in plaque psoriasis treatment

22 October 2020 - U.S. Prescribing Information updated to include PSO-LONG clinical trial data concerning long-term use (52 weeks) of twice-weekly ...

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FDA approves fewer generics in FY2020, ending record streak

21 October 2020 - After four straight years of posting record numbers of abbreviated new drug application approvals, the US ...

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NICE in favour of another highly specialised technology

21 October 2020 - Familial chylomicronaemia syndrome is a rare and potentially life-threatening condition that has a significant effect on the ...

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NICE recommended use of Opdivo for another indication

20 October 2020 - This marks the tenth NICE recommendation for nivolumab. ...

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Zosano Pharma receives complete response letter from FDA for Qtrypta

21 October 2020 - FDA feedback consistent with FDA’s preliminary communication in September. ...

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Health Canada has approved Taltz (ixekizumab) for the treatment of non-radiographic axial spondyloarthritis

19 October 2020 - Taltz is now approved to treat patients across the axSpA spectrum, including ankylosing spondylitis and non-radiographic axSpA. ...

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Glenmark Pharmaceuticals receives ANDA approval for sirolimus 0.5 mg, 1 mg and 2 mg tablets

19 October 2020 - Glenmark Pharmaceuticals has received final approval by the United States FDA for sirolimus 0.5 mg, 1 mg ...

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Octapharma announces FDA approval of updated Nuwiq Prescribing Information to include immunogenicity data in previously untreated patients

19 October 2020 - Octapharma is pleased to announce that the U.S. FDA has approved an updated Prescribing Information for Nuwiq, ...

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Neurelis announces FDA approval of extended expiration dating for Valtoco (diazepam nasal spray)

19 October 2020 - Neurelis today that the U.S. FDA has granted extended expiration dating for the company's lead product, Valtoco ...

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Bristol Myers Squibb receives positive CHMP opinion recommending Opdivo (nivolumab) as second-line treatment for unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma

16 October 2020 - Application based on Phase 3 ATTRACTION-3 trial demonstrating a statistically significant and clinically meaningful improvement in patients’ ...

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