Blog
RSS FeedPosted by Michael Wonder on 18 Sep 2018
FDA grants Lin BioScience rare paediatric disease status for LBS-008 to treat Stargardt disease
17 September 2018 - Designation enhances FDA orphan drug designation for Phase I candidate targeting incurable blindness in children. ...
Posted by Michael Wonder on 17 Sep 2018
FDA approves device for treatment of acute coronary artery perforations
17 September 2018 - The U.S. FDA today approved a device intended to treat acute coronary artery perforations, or tears in ...
Posted by Michael Wonder on 17 Sep 2018
FDA grants rare paediatric disease designation to Cellectar Biosciences’ CLR 131 for the treatment of osteosarcoma
17 September 2018 - Cellectar Biosciences announces today that the U.S. FDA has granted rare paediatric disease designation to CLR 131 ...
Posted by Michael Wonder on 17 Sep 2018
Antimicrobial resistance: FDA discusses reimbursement reforms
17 September 2018 - Reimbursement reforms for antimicrobial treatments could include “a mix of milestone payments and subscription fees for ...
Posted by Michael Wonder on 17 Sep 2018
Sun Pharma and SPARC announce US FDA approval of Xelpros to treat open-angle glaucoma or ocular hypertension
14 September 2018 - Xelpros (latanoprost ophthalmic emulsion) 0.005% for topical ophthalmic use is the first and only benzalkonium chloride-free (BAK-free) ...
Posted by Michael Wonder on 16 Sep 2018
Teva announces U.S. approval of Ajovy (fremanezumab-vfrm) injection, the first and only anti-CGRP treatment with both quarterly and monthly dosing for the preventive treatment of migraine in adults
14 September 2018 - Teva Pharmaceutical Industries today announced that the U.S. FDA has approved Ajovy (fremanezumab-vfrm) injection for the preventive ...
Posted by Michael Wonder on 15 Sep 2018
Single FDA centre fo rare diseases could be 'negative' to rare disease cause
14 September 2018 - FDA's Center for Drug Evaluation and Research Director Janet Woodcock advised against a single FDA Centre of ...
Posted by Michael Wonder on 14 Sep 2018
FDA approves device for treatment of acute coronary artery perforation
14 September 2018 - The U.S. FDA today approved a device intended to treat acute coronary artery perforations, or tears in ...
Posted by Michael Wonder on 14 Sep 2018
FDA approves subcutaneous formulation of Actemra for use in active systemic juvenile idiopathic arthritis, a rare form of juvenile arthritis
13 September 2018 - Genentech announced today that the U.S. FDA has approved the subcutaneous formulation of Actemra (tocilizumab) for the ...
Posted by Michael Wonder on 14 Sep 2018
Miransertib (ARQ 092) granted fast track designation for the treatment of PIK3CA-related overgrowth spectrum
13 September 2018 - ArQule today announced that the U.S. FDA has granted fast track designation to miransertib (ARQ 092) for ...
Posted by Michael Wonder on 14 Sep 2018
Ironwood Pharmaceuticals announces FDA fast track designation for praliciguat for the treatment of heart failure with preserved ejection fraction
13 September 2018 - Praliciguat Phase II trial in HFpEF continues to enrol patients with top-line data expected in the second ...
Posted by Michael Wonder on 14 Sep 2018
Acorda announces FDA extends Inbrija NDA review period
13 September 2018 - New PDUFA date of 5 January 2019. ...
Posted by Michael Wonder on 13 Sep 2018
Can a cancer drug originated in China be a success in the U.S.?
13 September 2018 - While China has prospered in a variety of technologies over the last decade, one area where growth ...
Posted by Michael Wonder on 13 Sep 2018
FDA to review Eylea (aflibercept) injection for the treatment of diabetic retinopathy
13 September 2018 - Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for review the supplemental biologics license application ...
Posted by Michael Wonder on 13 Sep 2018
BIO, Allergan and Roche call for FDA flexibility with patient experience data
13 September 2018 - Industry group BIO and biopharma companies Allergan and Roche are calling for the FDA to be ...