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RSS FeedPosted by Michael Wonder on 25 Dec 2019
Correvio receives complete response letter from U.S. FDA for Brinavess and provides update on recent events
24 December 2019 - Correvio Pharma today announced it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 24 Dec 2019
Teligent announces FDA request for further data on complex drug
23 December 2019 - Teligent today announced its development partner has received a complete response letter from the U.S. FDA for ...
Posted by Michael Wonder on 24 Dec 2019
Takeda receives complete response letter from U.S. FDA for the investigational subcutaneous formulation of Entyvio (vedolizumab) as a maintenance therapy in adults with moderate to severe ulcerative colitis
20 December 2019 - Takeda today announced that it has received a complete response letter from the U.S. FDA in response ...
Posted by Michael Wonder on 24 Dec 2019
FibroGen submits new drug application to the U.S. FDA for roxadustat in patients with anaemia of chronic kidney disease
23 December 2019 - New drug application supported by positive global Phase 3 efficacy and safety results. ...
Posted by Michael Wonder on 24 Dec 2019
Zosano announces FDA submission of new drug application for Qtrypta
23 December 2019 - Zosano Pharma today announced the submission of a 505(b)(2) new drug application for Qtrypta to the U.S. ...
Posted by Michael Wonder on 24 Dec 2019
BioMarin submits biologics license application to U.S. FDA for valoctocogene roxaparvovec to treat haemophilia A
23 December 2019 - First marketing application submission in U.S. for gene therapy directed at any type of haemophilia. ...
Posted by Michael Wonder on 24 Dec 2019
Seattle Genetics announces submission of tucatinib new drug application to the U.S. FDA for patients with locally advanced or metastatic HER2 positive breast cancer
23 December 2019 - Submission based on positive pivotal HER2CLIMB trial results recently oresented at the 2019 San Antonio Breast Cancer ...
Posted by Michael Wonder on 24 Dec 2019
FDA approves Intra-Cellular Therapies’ novel anti-psychotic, Caplyta (lumateperone) for the treatment of schizophrenia in adults
23 December 2019 - Intra-Cellular Therapies today announced that Caplyta (lumateperone) has been approved by the U.S. FDA for the ...
Posted by Michael Wonder on 24 Dec 2019
Karyopharm submits new drug application to U.S. FDA for Xpovio (selinexor) as a treatment for patients with relapsed or refractory diffuse large B-cell lymphoma
23 December 2019 - Karyopharm Therapeutics today announced it has submitted a new drug application to the U.S. FDA seeking accelerated ...
Posted by Michael Wonder on 24 Dec 2019
FDA approves first generics of Eliquis
23 December 2019 - The U.S. FDA has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce ...
Posted by Michael Wonder on 24 Dec 2019
FDA approves new treatment for adults with migraine
23 December 2019 - The U.S. Food and Drug Administration today approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of ...
Posted by Michael Wonder on 22 Dec 2019
ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV
21 December 2019 - ViiV Healthcare, with Pfizer and Shionogi, has received a complete response letter from the US FDA regarding ...
Posted by Michael Wonder on 21 Dec 2019
FDA approves Ortho Dermatologics' Arazlo (tazarotene) 0.045% lotion, for acne vulgaris
19 December 2019 - First tazarotene acne treatment approved in lotion formulation. ...
Posted by Michael Wonder on 21 Dec 2019
Sunovion announces FDA filing acceptance of resubmitted new drug application for apomorphine sublingual film
20 December 2019 - Sunovion Pharmaceuticals today announced that the U.S. FDA has accepted its new drug application for apomorphine ...
Posted by Michael Wonder on 21 Dec 2019
Nabriva Therapeutics resubmits new drug application for intravenous Contepo (fosfomycin) for Injection
20 December 2019 - Nabriva anticipates a six month review period by the Food and Drug Administration. ...