Blog
RSS FeedPosted by Michael Wonder on 29 Dec 2018
Emergent BioSolutions announces submission to FDA of application covering emergency use authorisation for NuThrax
28 December 2018 - Emergent BioSolutions announced today the submission of an application to the U.S. FDA for potential emergency use ...
Posted by Michael Wonder on 28 Dec 2018
Spectrum Pharmaceuticals announces submission of biologics license application to the FDA for Rolontis (eflapegrastim) as a treatment for chemotherapy-induced neutropenia
27 December 2018 - Submission based on results from two large, positive pivotal trials. ...
Posted by Michael Wonder on 27 Dec 2018
Kala Pharmaceuticals announces new drug application for KPI-121 0.25% for dry eye disease has been accepted for review by the U.S. FDA
26 December 2018 - KPI-121 0.25% expected to be the first product indicated for the temporary relief of signs and symptoms ...
Posted by Michael Wonder on 27 Dec 2018
Acer Therapeutics announces FDA acceptance of NDA and priority review for Edsivo for the treatment of vEDS
26 December 2018 - Acer continues progress toward goal of commercialising Edsivo. ...
Posted by Michael Wonder on 23 Dec 2018
Notification of a new drug application for HP-3070 (transdermal patch for the treatment of schizophrenia) in the U.S
17 December 2018 - Hisamitsu Pharmaceutical announces that a New Drug Application has been submitted to the U.S. FDA seeking approval ...
Posted by Michael Wonder on 23 Dec 2018
Fennec Pharmaceuticals initiates rolling submission new drug application to US FDA for Pedmark
20 December 2018 - Pedmark is proposed to be indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients ...
Posted by Michael Wonder on 23 Dec 2018
Assertio Therapeutics announces submission of NDA for FDA approval of cosyntropin depot
20 December 2018 - Submission advances company’s strategy to build a new orphan/specialty business and aligns with company’s mission of putting ...
Posted by Michael Wonder on 23 Dec 2018
Bavarian Nordic announces FDA acceptance and priority review of biologics license application for MVA-BN smallpox vaccine
21 December 2018 - Bavarian Nordic today announced that the U.S. FDA has accepted its Biologics License Application (BLA) for the ...
Posted by Michael Wonder on 23 Dec 2018
Janssen submits application to U.S. FDA seeking approval of Stelara (ustekinumab) for treatment of moderately to severely active ulcerative colitis
20 December 2018 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental biologics license ...
Posted by Michael Wonder on 22 Dec 2018
Foamix submits new drug application to U.S. FDA seeking approval of FMX101 in treatment of moderate-to-severe acne
21 December 2018 - Foamix Pharmaceuticals today announced that it has submitted a new drug application to the U.S. FDA seeking ...
Posted by Michael Wonder on 22 Dec 2018
Aimmune Therapeutics submits BLA to FDA for AR101 for the treatment of peanut allergy in children and adolescents ages 4–17
21 December 2018 - Aimmune Therapeutics today announced that it has submitted a biologics license application to the U.S. FDA for ...
Posted by Michael Wonder on 21 Dec 2018
Merck provides update on Keytruda (pembrolizumab) supplemental biologics license application for KEYNOTE-042 trial
20 December 2018 - Merck today announced that the U.S. FDA has extended the action date for the supplemental biologics license ...
Posted by Michael Wonder on 21 Dec 2018
Nabriva Therapeutics submits new drug applications to U.S. FDA for intravenous and oral lefamulin to treat community-acquired bacterial pneumonia in adults
20 December 2018 - Nabriva Therapeutics announced the submission of two new drug applications to the U.S. FDA for the ...
Posted by Michael Wonder on 20 Dec 2018
AbbVie submits new drug application to U.S. FDA and marketing authorisation application to EMA for upadacitinib for treatment of adults with moderate to severe rheumatoid arthritis
20 December 2018 - Regulatory applications supported by robust SELECT Phase 3 program evaluating more than 4,000 patients with moderate to ...
Posted by Michael Wonder on 20 Dec 2018
Pharmaxis announces resubmission of Bronchitol NDA in USA
18 December 2018 - Pharmaxis today announced the resubmission of the Bronchitol new drug application with the United States FDA ...