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RSS FeedPosted by Michael Wonder on 22 Oct 2020
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 ...
Posted by Michael Wonder on 22 Oct 2020
Nexplanon recommended after second submission
22 October 2020 - The first submission was withdrawn. ...
Posted by Michael Wonder on 22 Oct 2020
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 ...
Posted by Michael Wonder on 22 Oct 2020
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. ...
Posted by Michael Wonder on 22 Oct 2020
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 ...
Posted by Michael Wonder on 22 Oct 2020
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 ...
Posted by Michael Wonder on 21 Oct 2020
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 ...
Posted by Michael Wonder on 21 Oct 2020
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 ...
Posted by Michael Wonder on 21 Oct 2020
NICE recommended use of Opdivo for another indication
20 October 2020 - This marks the tenth NICE recommendation for nivolumab. ...
Posted by Michael Wonder on 21 Oct 2020
Zosano Pharma receives complete response letter from FDA for Qtrypta
21 October 2020 - FDA feedback consistent with FDA’s preliminary communication in September. ...
Posted by Michael Wonder on 20 Oct 2020
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. ...
Posted by Michael Wonder on 19 Oct 2020
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 ...
Posted by Michael Wonder on 19 Oct 2020
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, ...
Posted by Michael Wonder on 19 Oct 2020
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 ...
Posted by Michael Wonder on 19 Oct 2020
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’ ...