Blog
RSS FeedPosted by Michael Wonder on 06 Jan 2019
CRISPR Therapeutics and Vertex announce FDA fast track designation for CTX001 for the treatment of sickle cell disease
4 January 2019 - CRISPR Therapeutics and Vertex Pharmaceuticals today announced that the U.S. FDA has granted fast track Designation for ...
Posted by Michael Wonder on 03 Jan 2019
Aadi Bioscience receives breakthrough therapy designation for Tarzifyx (ABI-009) in PEComa indication
3 January 2019 - Aadi Bioscience today announced that its drug Tarzifyx (sirolimus albumin-bound nanoparticles for injectable suspension, ABI-009) has received ...
Posted by Michael Wonder on 03 Jan 2019
ImmusanT secures fast track designation for lead therapeutic vaccine candidate Nexvax2 for patients with celiac disease
2 January 2019 - Nexvax2 has been designed to potentially restore immune tolerance to gluten in patients with celiac disease. ...
Posted by Michael Wonder on 02 Jan 2019
ProQR receives fast track designation from FDA for QR-421a for Usher Syndrome Type 2
2 January 2019 - ProQR Therapeutics today announced that it received fast track designation from the FDA for QR-421a. ...
Posted by Michael Wonder on 02 Jan 2019
Bristol-Myers Squibb’s Sprycel (dasatinib) tablets now approved in combination with chemotherapy in certain paediatric patients with Philadelphia chromosome-positive acute lymphoblastic leukemia
2 January 2018 - Approval marks second paediatric leukaemia indication for Sprycel. ...
Posted by Michael Wonder on 02 Jan 2019
U.S. FDA approves Portola Pharmaceuticals’ prior approval supplement for Andexxa Generation 2 manufacturing process
31 December 2018 - Expands patient access to Andexxa, the first and only antidote for reversal of the Factor Xa ...
Posted by Michael Wonder on 01 Jan 2019
FDA grants priority review designation for Heron Therapeutics' NDA for HTX-011, a non-opioid for post-operative pain management
31 December 2018 - FDA not currently planning advisory Committee Meeting for NDA. ...
Posted 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 ...