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RSS FeedPosted by Michael Wonder on 30 May 2019
Fibrocell receives FDA regenerative medicine advanced therapy designation for FCX-007 gene therapy for the treatment of RDEB
29 May 2019 - Fibrocell Science today announced that the U.S. FDA has granted the regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 23 May 2019
Avadel Pharmaceuticals announces FDA acceptance of new drug application for AV001
22 May 2019 - AV001 granted priority review. ...
Posted by Michael Wonder on 22 May 2019
PolyPid receives a second QIDP designation for D-PLEX100 in abdominal surgery
21 May 2019 - PolyPid Ltd announced today that the United States FDA has granted a second qualified infectious disease product ...
Posted by Michael Wonder on 29 Apr 2019
U.S. FDA accepts new drug application and grants priority review for darolutamide
29 April 2019 - Bayer today announced the U.S. FDA has accepted the new drug application and granted priority review to ...
Posted by Michael Wonder on 23 Apr 2019
Priority review vouchers have helped to improve access to drugs targeting neglected diseases
22 April 2019 - The FDA priority review vouchers for neglected tropical diseases are aimed to incentivise pharmaceutical companies to ...
Posted by Michael Wonder on 15 Apr 2019
Novartis announces FDA filing acceptance and priority review of brolucizumab (RTH258) for patients with wet AMD
15 April 2019 - Filing is based on Phase III data from the HAWK and HARRIER trials for brolucizumab. ...
Posted by Michael Wonder on 13 Apr 2019
Polyphor's antibiotic murepavadin receives US FDA qualified infectious disease product designation in four new indications
12 April 2019 - Polyphor's antibiotic murepavadin receives US FDA qualified infectious disease product designation in four new indications. ...
Posted by Michael Wonder on 21 Mar 2019
Enzyvant's investigational Farber disease enzyme replacement therapy, RVT-801, receives FDA fast track and rare paediatric disease designations
21 March 2019 - Enzyvant today announced that the U.S. FDA has granted are paediatric disease and fast track designations for ...
Posted by Michael Wonder on 20 Mar 2019
Iterum Therapeutics receives QIDP for oral and IV sulopenem in four additional indications as well as fast track designation
19 March 2019 - New designations in community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammatory disease demonstrate the ...
Posted by Michael Wonder on 19 Mar 2019
Biohaven secures priority review voucher to expedite regulatory review of Rimegepant Zydis ODT new drug application
18 March 2019 - Rimegepant Zydis orally disintegrating tablet is Biohaven's lead oral CGRP receptor antagonist drug candidate from its Nojection ...
Posted by Michael Wonder on 19 Mar 2019
GW Pharmaceuticals announces the sale of priority review voucher for $105 million
18 March 2019 - GW Pharmaceuticals today announced that GW Research Ltd. has entered into a definitive agreement to sell its ...
Posted by Michael Wonder on 08 Mar 2019
FDA to undertake priority review of Dupixent (dupilumab) for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps
8 March 2019 - The U.S. FDA has accepted for priority review the supplemental biologics license application for Dupixent (dupilumab) as ...
Posted by Michael Wonder on 06 Mar 2019
FDA grants rare paediatric disease designation to odiparcil for the treatment of MPS VI
5 March 2019 - Inventiva eligible to receive priority review voucher upon approval of odiparcil for the treatment of MPS VI. ...
Posted by Michael Wonder on 06 Mar 2019
U.S. FDA grants priority review for fedratinib new drug application in myelofibrosis
5 March 2019 - U.S. FDA sets Prescription Drug User Fee Act action date for 3 September 2019. ...
Posted by Michael Wonder on 05 Mar 2019
Lilly receives FDA priority review designation for Emgality (galcanezumab-gnlm) injection for the preventive treatment of episodic cluster headache in adults
5 March 2019 - Eli Lilly and Company announced today that the U.S. FDA has granted priority review for its ...