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RSS FeedPosted by Michael Wonder on 01 Jan 2019
Adamis Pharmaceuticals submits new drug application to FDA for its naloxone pre-filled syringe
31 December 2018 - Adamis Pharmaceuticals today announced the submission of a new drug application to the U.S. Food and ...
Posted by Michael Wonder on 30 Dec 2018
Adamis Pharmaceuticals submits new drug application to FDA for its tadalafil sublingual tablet
28 December 2018 - -- Adamis Pharmaceuticals today announced the submission of a new drug application to the U.S. FDA ...
Posted 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 28 Dec 2018
US FDA requests further data for VivaGel BV approval
27 December 2018 - Regulatory processes underway continue in other markets and are independent of FDA approval. ...
Posted by Michael Wonder on 28 Dec 2018
Horizon Pharma announces FDA approval to expand the age range for Ravicti (glycerol phenylbutyrate) oral liquid to include newborns
27 December 2018 - Horizon Pharma today announced the U.S. FDA has approved a supplemental new drug application to expand the ...
Posted by Michael Wonder on 27 Dec 2018
BioXcel Therapeutics receives FDA fast track designation for BXCL501 for acute treatment of agitation
27 December 2018 - Fast track designation for BXCL501 will help facilitate anticipated registration trials in 2019 upon completion of pharmacokinetic ...
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 27 Dec 2018
FDA approves Vaxelis, Sanofi and MSD’s paediatric hexavalent combination vaccine
26 December 2018 - The U.S. FDA has approved Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, ...
Posted by Michael Wonder on 25 Dec 2018
Valneva awarded FDA fast track designation for Chikungunya vaccine candidate
21 December 2018 - Valneva announced today that the U.S. FDA has granted fast track designation for its chikungunya vaccine candidate, ...
Posted by Michael Wonder on 24 Dec 2018
Braeburn announces tentative FDA approval of Brixadi (buprenorphine) extended-release injection for the treatment of moderate to severe opioid use disorder
23 December 2018 - Brixadi is a long-acting buprenorphine injectable with both weekly and monthly doses to align with the way ...
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
Gritstone Oncology announces FDA fast track designation for GRANITE-001 for the treatment of colorectal cancer
20 December 2018 - Gritstone Oncology today announced that the U.S. FDA has granted fast track designation to GRANITE-001 for the ...
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 ...