Blog
RSS FeedPosted by Michael Wonder on 18 Aug 2020
Imfinzi granted FDA priority review for less-frequent, fixed-dose use
18 August 2020 - Option would extend dosing to four weeks in non-small cell lung and bladder cancer reducing medical visits ...
Posted by Michael Wonder on 17 Aug 2020
Myovant Sciences announces FDA acceptance of new drug application for once daily relugolix combination tablet for uterine fibroids
17 August 2020 - FDA sets target action date of 1 June 2021. ...
Posted by Michael Wonder on 17 Aug 2020
G1 Therapeutics announces acceptance and priority review of NDA for trilaciclib for patients with small cell lung cancer
17 August 2020 - G1 launching expanded access program for patients with small cell lung cancer in the U.S.. ...
Posted by Michael Wonder on 17 Aug 2020
United Therapeutics announces U.S. FDA filing acceptance of supplemental new drug application for Tyvaso for pulmonary hypertension associated with interstitial lung disease
17 August 2020 - United Therapeutics today announced that the U.S. FDA accepted for review the supplemental new drug application ...
Posted by Michael Wonder on 13 Aug 2020
TG Therapeutics announces FDA acceptance of new drug application for umbralisib as a treatment for patients with previously treated marginal zone lymphoma and follicular lymphoma
13 August 2020 - TG Therapeutics today announced that the U.S. FDA has accepted the Company’s new drug application for umbralisib, ...
Posted by Michael Wonder on 13 Aug 2020
Novartis announces FDA filing acceptance of Xolair (omalizumab) pre-filled syringe for self-administration across all indications
13 August 2020 - If approved, Xolair self-administration would offer a more flexible option to help select patients manage their treatment ...
Posted by Michael Wonder on 12 Aug 2020
FDA accepts evinacumab biologics license application for priority review as a treatment for patients with HoFH, an ultra-rare inherited form of high cholesterol
12 August 2020 - Homozygous familial hypercholesterolaemia affects approximately 1,300 patients in the U.S., the vast majority of whom are unable ...
Posted by Michael Wonder on 11 Aug 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases announce U.S. FDA acceptance of biologics license application for pegunigalsidase alfa for the proposed treatment of Fabry disease and grants priority review
11 August 2020 - Protalix BioTherapeutics together with its development and commercialization partner Chiesi Global Rare Diseases, a unit of Chiesi, ...
Posted by Michael Wonder on 10 Aug 2020
Gilead submits new drug application to U.S. Food and Drug Administration for Veklury (remdesivir) for the treatment of COVID-19
10 August 2020 - Veklury is currently available in the U.S. for the treatment of severe COVID-19 under an Emergency Use ...
Posted by Michael Wonder on 10 Aug 2020
Aquestive Therapeutics receives FDA fast track designation for AQST-108 (sublingual film formulation delivering systemic epinephrine) for treatment of allergic reactions including anaphylaxis
10 August 2020 - Finalising preparations for pharmacokinetic clinical trials of AQST-108. ...
Posted by Michael Wonder on 10 Aug 2020
Mallinckrodt announces U.S. FDA filing acceptance of biologics license application for StrataGraft regenerative skin tissue for treatment of adults with deep partial-thickness thermal burns
10 August 2020 - StrataGraft skin tissue, if approved, could reduce or eliminate the need for auto-grafting of healthy skin to ...
Posted by Michael Wonder on 07 Aug 2020
FDA accepts Biogen's aducanumab biologics license application for Alzheimer's disease with priority review
7 August 2020 - If approved, aducanumab would be the first treatment to meaningfully change the course of Alzheimer’s disease. ...
Posted by Michael Wonder on 07 Aug 2020
Y-mAbs announces completion of submission of omburtamab biologics license application to FDA
6 August 2020 - Y-mAbs Therapeutics today announced that on 5 August 2020, the Company completed the submission of its biologics ...
Posted by Michael Wonder on 04 Aug 2020
Pacira BioSciences announces FDA acceptance of sNDA for Exparel use in paediatric patients
4 August 2020 - sNDA submission based on positive Phase 3 data supporting expansion of the Exparel label to include use ...
Posted by Michael Wonder on 03 Aug 2020
FDA accepts and grants priority review of Vanda's applications for Hetlioz (tasimelteon) in the treatment of Smith-Magenis syndrome
3 August 2020 - Vanda Pharmaceuticals today announced that the U.S. FDA has accepted for priority review Vanda's applications for Smith-Magenis ...