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RSS FeedPosted by Michael Wonder on 24 Jun 2020
Mayne Pharma announces FDA filing acceptance of new drug application for E4/DRSP in the US
24 June 2020 - Mayne Pharma is pleased to announce the new drug application for E4/DRSP to prevent pregnancy has been ...
Posted by Michael Wonder on 23 Jun 2020
Imbruvica (ibrutinib) seeks to expand U.S. label with long-term data in Waldenström's macroglobulinaemia
23 June 2020 - Submission is based on results of more than five years of follow-up data from the Phase 3 ...
Posted by Michael Wonder on 23 Jun 2020
Myovant Sciences announces priority review and FDA acceptance of new drug application for once daily, oral relugolix for advanced prostate cancer
22 June 2020 - Priority review status expected to accelerate review, with a target FDA action date of 20 December ...
Posted by Michael Wonder on 22 Jun 2020
FDA accepts supplemental biologics license application for Botox (onabotulinumtoxinA) for the treatment of paediatric patients with neurogenic detrusor overactivity
22 June 2020 - Application seeks to extend use of Botox for patients 5 to 17 years old. ...
Posted by Michael Wonder on 18 Jun 2020
TG Therapeutics completes rolling submission of new drug application to the U.S. FDA for umbralisib as a treatment for patients with previously treated marginal zone lymphoma or follicular lymphoma
17 June 2020 - TG Therapeutics today announced the completion of the rolling submission of a new drug application to the ...
Posted by Michael Wonder on 16 Jun 2020
Acadia Pharmaceuticals submits supplemental new drug application to U.S. FDA for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis
15 June 2020 - Submission based on positive results from the Phase 3 HARMONY study which showed a statistically significant 2.8 ...
Posted by Michael Wonder on 15 Jun 2020
Biogen’s FDA application for Alzheimer’s drug drags on
15 June 2020 - Biogen’s filing of aducanumab, an investigational Alzheimer’s drug, for U.S. approval is drifting from its initial ...
Posted by Michael Wonder on 10 Jun 2020
Mallinckrodt completes rolling submission of biologics license application for StrataGraft regenerative skin tissue to U.S. FDA
9 June 2020 - StrataGraft skin tissue is in development as potential new treatment option for patients with deep partial-thickness thermal ...
Posted by Michael Wonder on 08 Jun 2020
CytoDyn receives BLA acknowledgment letter from the FDA
8 June 2020 - PDUFA date could be set by the FDA on 10 July. ...
Posted by Michael Wonder on 04 Jun 2020
Adamas announces FDA filing acceptance of sNDA to modify the indication statement for Gocovri to include treatment for Parkinson’s disease patients receiving levodopa and experiencing OFF episodes
4 June 2020 - Adamas Pharmaceuticals today announced that its supplemental new drug application for Gocovri as a treatment for OFF ...
Posted by Michael Wonder on 04 Jun 2020
U.S. FDA accepts Pharmaessentia's application for ropeginterferon alfa-2b to treat polycythemia vera
4 June 2020 - U.S. team begins commercial preparations for novel pegylated interferon with appointment of General Manager Meredith Manning. ...
Posted by Michael Wonder on 02 Jun 2020
Y-mAbs announces U.S. FDA acceptance of biologics license application for Danyelza (naxitamab) for the treatment of neuroblastoma for priority review
2 June 2020 - Y-mAbs Therapeutics today announced that the biologics license application for Danyelza (naxitamab) for the treatment of patients ...
Posted by Michael Wonder on 02 Jun 2020
Novartis provides update on FDA review of ofatumumab, a self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis
2 June 2020 - Novartis today announced that it has received notice from the US FDA that the agency has extended ...
Posted by Michael Wonder on 02 Jun 2020
Sumitovant Biopharma announces Myovant Sciences' submission of new drug application to the FDA for once daily relugolix combination tablet for the treatment of women with uterine fibroids
1 June 2020 - Sumitovant Biopharma announced today that Myovant Sciences has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 02 Jun 2020
AVEO Oncology announces FDA acceptance for filing of a new drug application for tivozanib as a treatment of relapsed or refractory renal cell carcinoma
1 June 2020 - Tivozanib assigned PDUFA target action date of 31 March 2021; FDA indicates that it does not currently ...