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RSS FeedPosted by Michael Wonder on 21 Apr 2020
Myovant Sciences Submits new drug application to the FDA for once daily, oral relugolix for the treatment of men with advanced prostate cancer
21 April 2020 - Myovant expects to submit a second application for relugolix combination tablet for women with uterine fibroids in ...
Posted by Michael Wonder on 20 Apr 2020
FDA and EMA accept applications for Genentech’s Ocrevus (ocrelizumab) shorter two hour infusion time
19 April 2020 - Reduces infusion time to 2 hours from the current 3.5 hours for patients with relapsing or primary ...
Posted by Michael Wonder on 17 Apr 2020
FDA accepts for priority review biologics license application for REGN-EB3 to treat Ebola
16 April 2020 - REGN-EB3 developed via same rapid response platform currently being leveraged to develop novel COVID-19 antibody therapy. ...
Posted by Michael Wonder on 16 Apr 2020
Provention Bio initiates rolling submission of biologic license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals
16 April 2020 - Rolling submission initiated under breakthrough therapy designation. ...
Posted by Michael Wonder on 16 Apr 2020
Mayne Pharma submits new drug application for E4/DRSP to the FDA
16 April 2020 - Mayne Pharma and Mithra Pharmaceuticals today announced that Mayne Pharma has submitted a new drug application ...
Posted by Michael Wonder on 13 Apr 2020
Fennec Pharmaceuticals announces FDA filing acceptance and priority review of new drug application for Pedmark
13 April 2020 - FDA grants priority review and sets a Prescription Drug User Fee Act target action date of 10 ...
Posted by Michael Wonder on 09 Apr 2020
Merck and Pfizer receive US FDA breakthrough therapy designation and submit application for Bavencio for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
9 April 2020 - Breakthrough therapy designation and submission based on positive Phase III JAVELIN Bladder 100 study results. ...
Posted by Michael Wonder on 09 Apr 2020
Liquidia announces FDA acceptance of new drug application for LIQ861 (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension
8 April 2020 - Liquidia Technologies today announced that the US FDA accepted for review the Company’s new drug application seeking ...
Posted by Michael Wonder on 08 Apr 2020
Bristol Myers Squibb announces acceptance of U.S. and EU regulatory filings for Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with limited chemotherapy in first-line lung cancer
8 April 2020 - Submissions based on results from Phase 3 CheckMate-9LA trial. ...
Posted by Michael Wonder on 08 Apr 2020
Genentech provides regulatory update on risdiplam for the treatment of spinal muscular atrophy
7 April 2020 - U.S. FDA extends review time for risdiplam following agreed submission of additional data, including SUNFISH Part 2. ...
Posted by Michael Wonder on 08 Apr 2020
Alnylam completes rolling submission of new drug application to the U.S. FDA and submits marketing authorisation application to the EMA for lumasiran for the treatment of primary hyperoxaluria type 1
7 April 2020 - Lumasiran is the first potential therapeutic to demonstrate substantial reduction in urinary oxalate excretion. ...
Posted by Michael Wonder on 07 Apr 2020
Merck receives priority review from FDA for second application for Keytruda (pembrolizumab) based on biomarker, regardless of tumour type
7 April 2020 - Supplemental biologics license application accepted for Keytruda monotherapy in patients whose tumours are tumour mutational burden-high who ...
Posted by Michael Wonder on 07 Apr 2020
Mallinckrodt initiates rolling submission of biologics license application for StrataGraft regenerative skin tissue to U.S. FDA
6 April 2020 - Application is supported by data from pivotal phase 3 study for the treatment of deep partial-thickness thermal ...
Posted by Michael Wonder on 03 Apr 2020
Zealand Pharma submits new drug application to the U.S. FDA for the dasiglucagon HypoPal Rescue Pen for treatment of severe hypoglycemia
31 March 2020 - The dasiglucagon HypoPal Rescue Pen new drug application represents a major milestone in Zealand Pharma’s efforts to ...
Posted by Michael Wonder on 02 Apr 2020
Y-mAbs announces submission of naxitamab biologics license application to U.S. FDA
1 April 2020 - Y-mAbs Therapeutics today announced that the Company has completed the submission of its biologics license application under ...