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RSS FeedPosted by Michael Wonder on 21 Nov 2018
GSK submits US regulatory filing to expand the use of Nucala in children with severe eosinophilic asthma
19 November 2018 - GSK today announced the filing of a supplemental biologics license application to the US FDA seeking ...
Posted by Michael Wonder on 15 Nov 2018
Merck begins rolling submission of licensure application for V920 (rVSV∆G-ZEBOV-GP) to U.S. FDA
13 November 2018 - V920 is the Company’s investigational vaccine for Ebola Zaire. ...
Posted by Michael Wonder on 14 Nov 2018
U.S. FDA accepts for filing Shire’s supplemental new drug application for Gattex (teduglutide [rDNA origin]) for children with short bowel syndrome
13 November 2018 - Seeking approval for the potential use of Gattex to paediatric patients builds on Shire’s decade-long commitment ...
Posted by Michael Wonder on 14 Nov 2018
Retrophin announces U.S. FDA acceptance of NDA filing for the new formulation of Thiola (tiopronin) in the treatment of cystinuria
12 November 2018 - PDUFA date set for 30 June 2019. ...
Posted by Michael Wonder on 14 Nov 2018
Lilly submits new drug application to the FDA for lasmiditan for acute treatment of migraine, receives breakthrough therapy designation for Emgality (galcanezumab-gnlm) for prevention of episodic cluster headache
14 November 2018 - Lilly also plans to submit a supplemental biologics license application to the FDA for Emgality for the ...
Posted by Michael Wonder on 13 Nov 2018
FDA grants priority review to Roche’s Tecentriq in combination with Abraxane for the initial treatment of people with PD-L1-positive, metastatic triple-negative breast cancer
13 November 2018 - If approved, this Tecentriq (atezolizumab) combination would be the first cancer immunotherapy regimen for the treatment ...
Posted by Michael Wonder on 12 Nov 2018
US FDA accepts regulatory submission for Lynparza maintenance therapy in newly-diagnosed, BRCA mutated advanced ovarian cancer and grants priority review
12 November 2018 - First US regulatory submission acceptance for a PARP inhibitor as a first-line maintenance treatment for advanced ...
Posted by Michael Wonder on 07 Nov 2018
Acacia Pharma resubmits Barhemsys new drug application
6 November 2018 - Acacia Pharma announces that it has resubmitted its new drug application for Barhemsys (amisulpride injection) to the ...
Posted by Michael Wonder on 07 Nov 2018
FDA grants priority review for Dupixent (dupilumab) as potential treatment for adolescents with uncontrolled moderate to severe atopic dermatitis
6 November 2018 - Regeneron Pharmaceuticals and Sanofi today announced that the U.S. FDA has accepted for priority review the ...
Posted by Michael Wonder on 06 Nov 2018
Seattle Genetics submits supplemental biologics license application for Adcetris (brentuximab vedotin) in front-line treatment of CD30 expressing peripheral T-cell lymphomas
5 November 2018 - Submission based on positive Phase 3 ECHELON-2 trial evaluating Adcetris in frontline CD30-expressing peripheral T-cell lymphoma. ...
Posted by Michael Wonder on 02 Nov 2018
Sandoz decides not to pursue US biosimilar rituximab; will focus on robust biosimilar portfolio for unmet access and sustainability needs
2 November 2018 - Decision follows FDA request for additional information to complement submission for biosimilar rituximab. ...
Posted by Michael Wonder on 02 Nov 2018
Nabriva Therapeutics completes submission of new drug application to U.S. FDA for intravenous Contepo to treat complicated urinary tract infections
1 November 2018 - Nabriva Therapeutics announced it has submitted a new drug application to the U.S. FDA to seek ...
Posted by Michael Wonder on 31 Oct 2018
Heron announces FDA submission of HTX-011 NDA for post-operative pain management
31 October 2018 - Heron Therapeutics today announced the submission of its new drug application to the U.S. FDA for HTX-011. ...
Posted by Michael Wonder on 30 Oct 2018
Acer Therapeutics submits NDA for Edsivo for the treatment of vEDS
29 October 2018 - Acer Therapeutics today announced that it has submitted a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 29 Oct 2018
Xeris Pharmaceuticals announces FDA acceptance for review of NDA for its ready-to-use glucagon rescue pen
23 October 2018 - If approved, the Xeris glucagon rescue pen would be the first ready-to-use, room-temperature stable liquid glucagon in ...