Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 13 Sep 2018
Beleaguered price hiking drug CEO says he wasn't defending Shkreli, he was condemning FDA
13 September 2018 - Nirmal Mulye, founder of Nostrum Pharmaceuticals, became the latest CEO in the spotlight for raising drug prices. ...
Posted by Michael Wonder on 13 Sep 2018
FDA approves new kind of treatment for hairy cell leukaemia
13 September 2018 - The U.S. FDA today approved Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult ...
Posted by Michael Wonder on 13 Sep 2018
FDA issues 54 product-specific guidances to promote generic drug access and drug price competition
13 September 2018 - The U.S. FDA today announced a new set of product-specific guidances to support industry in identifying ...
Posted by Michael Wonder on 13 Sep 2018
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) monotherapy for first-line treatment of locally advanced or metastatic non-small cell lung cancer in patients whose tumours express PD-L1 (TPS ≥1%)
12 September 2018 - Application Based on Overall Survival Data from Pivotal Phase 3 KEYNOTE-042 Trial. ...
Posted by Michael Wonder on 12 Sep 2018
FDA to review supplemental biologics license application for Praluent (alirocumab) injection as potential treatment to reduce major adverse cardiovascular events
12 September 2018 - FDA also recently approved Praluent label update for some patients currently requiring LDL apheresis therapy. ...
Posted by Michael Wonder on 12 Sep 2018
Trump's early efforts to trim drug costs face patient backlash
11 September 2018 - President Trump’s bid to revamp Medicare to lower drug prices for seniors is getting pushback from ...