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RSS FeedPosted by Michael Wonder on 28 Jul 2020
Foresee Pharmaceuticals announces submission of NDA for FDA approval of LMIS 50 mg
27 July 2020 - Foresee Pharmaceuticals announced today that it has submitted to the U.S. FDA a new drug application ...
Posted by Michael Wonder on 27 Jul 2020
scPharmaceuticals announces FDA acceptance of Furoscix new drug application resubmission
27 July 2020 - FDA sets PDUFA date of 30 December 2020. ...
Posted by Michael Wonder on 27 Jul 2020
Eton Pharmaceuticals submits new drug application to the FDA for orphan drug dehydrated alcohol injection
27 July 2020 - Since the start of COVID-19, the FDA has recalled more than 75 contaminated hand sanitisers due to ...
Posted by Michael Wonder on 23 Jul 2020
ElsaLys Biotech announces submission of biologics license application to FDA for Leukotac (inolimomab) for the treatment of graft versus host disease in adult patients
23 July 2020 - The biologics license application will be reviewed under the FDA’s Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 21 Jul 2020
Aurinia announces U.S. FDA acceptance of the filing of new drug application and priority review for voclosporin for the treatment of lupus nephritis
21 July 2020 - FDA grants priority review and sets PDUFA date of 22 January 2021 . ...
Posted by Michael Wonder on 20 Jul 2020
Osmotica Pharmaceutical announces FDA user fee goal date of 29 December 2020 for arbaclofen extended release tablets
20 July 2020 - Osmotica Pharmaceuticals, through its subsidiary Osmotica Pharmaceutical US, announced today that the U.S. FDA considers the Company’s ...
Posted by Michael Wonder on 20 Jul 2020
Acadia Pharmaceuticals announces U.S. FDA accepted for filing the supplemental new drug application for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis
20 July 2020 - If approved, Nuplazid would be the first and only treatment indicated for dementia-related psychosis. ...
Posted by Michael Wonder on 20 Jul 2020
Orphazyme completes rolling submission of new drug application to U.S. FDA for arimoclomol for Niemann-Pick disease type C
20 July 2020 - Company expects to submit marketing authorisation application for arimoclomol for Niemann-Pick disease type C to European Medicines Agency ...
Posted by Michael Wonder on 16 Jul 2020
FDA grants priority review to Merck’s new drug application for vericiguat
16 July 2020 - Application based on first contemporary outcomes study focused exclusively on chronic heart failure patient population following a ...
Posted by Michael Wonder on 13 Jul 2020
FDA advises CytoDyn its application is incomplete
13 July 2020 - CytoDyn announced today it has received a refusal to file letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 10 Jul 2020
Leo Pharma announces U.S. FDA acceptance of biologics license application for tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis
9 July 2020 - Submission includes data from pivotal ECZTRA 1, 2 and ECZTRA 3 Phase 3 studies evaluating safety and ...
Posted by Michael Wonder on 09 Jul 2020
ChemoCentryx submits new drug application to the U.S. FDA for avacopan in ANCA associated vasculitis
9 July 2020 - ChemoCentryx today confirmed that the Company has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 09 Jul 2020
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for second-line treatment of patients with relapsed or refractory classical Hodgkin lymphoma
9 July 2020 - Application based on data comparing Keytruda to standard care (brentuximab vedotin) from pivotal Phase 3 KEYNOTE-204 trial. ...
Posted by Michael Wonder on 09 Jul 2020
Brilinta granted FDA priority review for the reduction of subsequent stroke in patients who had an acute ischaemic stroke or transient ischaemic attack
9 July 2020 - Brilinta in combination with aspirin could be the first FDA approved dual anti-platelet therapy to reduce the ...
Posted by Michael Wonder on 09 Jul 2020
CorMedix reports submission of Defencath new drug application
8 July 2020 - CorMedix today announced that all of the modules for the Defencath new drug application have been submitted ...