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RSS FeedPosted 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 ...
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
Acorda Therapeutics announces FDA approval of Inbrija (levodopa inhalation powder)
21 December 2018 - Expected to be available by prescription in first quarter 2019. ...
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 ...