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RSS FeedPosted by Michael Wonder on 30 Jul 2020
Merck announces two US regulatory milestones for Keytruda (pembrolizumab) in triple-negative breast cancer
30 July 2020 - FDA grants priority review to supplemental biologics license application for Keytruda plus chemotherapy for the treatment of ...
Posted by Michael Wonder on 30 Jul 2020
Eton Pharmaceuticals submits new drug application to the FDA for zonisamide oral suspension (ET-104)
30 July 2020 - Application is Eton’s sixth drug application under FDA review. ...
Posted by Michael Wonder on 29 Jul 2020
Ridgeback Biotherapeutics announces priority review of biologics license application for ansuvimab Ebola treatment
29 July 2020 - Ridgeback Biotherapeutics today announced the U.S. FDA has accepted the biologics license application and granted priority ...
Posted by Michael Wonder on 29 Jul 2020
Bristol Myers Squibb and bluebird bio announce submission of biologics license application to FDA for idecabtagene vicleucel (Ide-cel, bb2121) for adults with relapsed and refractory multiple myeloma
29 July 2020 - BLA submission based on results from pivotal Phase 2 KarMMa study evaluating ide-cel in heavily pre-treated patient ...
Posted 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 ...