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RSS FeedPosted by Michael Wonder on 23 Apr 2019
Pharma lobby nears spending records with drug prices under fire
23 April 2019 - Drug makers, groups disclose first-quarter spending increases. ...
Posted by Michael Wonder on 23 Apr 2019
FDA permits marketing of first medical device for treatment of ADHD
19 April 2019 - The U.S. FDA today permitted marketing of the first medical device to treat attention deficit hyperactivity disorder. ...
Posted by Michael Wonder on 23 Apr 2019
Intensity Therapeutics receives fast track designation from U.S. FDA for development of INT230-6 as treatment for relapsed or metastatic triple negative breast cancer
17 April 2019 - Intensity Therapeutics today announced that the U.S. FDA has granted fast track designation to the Company’s ...
Posted by Michael Wonder on 23 Apr 2019
FDA approves Merck’s Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma
22 April 2019 - Approval based on results of KEYNOTE-426, where Keytruda in combination with axitinib reduced the risk of death ...
Posted by Michael Wonder on 23 Apr 2019
US FDA approves Duaklir Pressair (aclidinium/formoterol) for patients with chronic obstructive pulmonary disease
17 April 2019 - Only twice-daily LAMA /LABA in the United States with COPD exacerbation data included in its prescribing information. ...
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 23 Apr 2019
U.S. FDA accepts biologics license application for eptinezumab
22 April 2019 - Alder BioPharmaceuticals today announced that the U.S. FDA has accepted for review the biologics license application for ...
Posted by Michael Wonder on 21 Apr 2019
Viela Bio receives U.S. FDA breakthrough therapy designation for inebilizumab for treatment of neuromyelitis optica spectrum disorder
18 April 2019 - Designation based on positive primary analysis of pivotal study, N-MOmentum. ...
Posted by Michael Wonder on 21 Apr 2019
Genfit announces FDA grant of breakthrough therapy designation to elafibranor for the treatment of PBC
18 April 2019 - FDA grants elafibranor breakthrough therapy designation, based on Phase 2 data, for treatment of primary biliary cholangitis ...
Posted by Michael Wonder on 21 Apr 2019
Moleculin receives FDA approval of fast track designation for annamycin
18 April 2019 - Moleculin Biotech today announced that the U.S. FDA has approved its request for fast track designation ...
Posted by Michael Wonder on 20 Apr 2019
FDA's efforts to advance the development of biologics
17 April 2019 - The FDA’s Center for Biologics Evaluation and Research is working at the forefront of 21st century ...
Posted by Michael Wonder on 20 Apr 2019
FDA approves first generic naloxone nasal spray to treat opioid overdose
19 April 2019 - Agency is also taking new steps to support development of over-the-counter and additional generics of naloxone to ...
Posted by Michael Wonder on 20 Apr 2019
Health Canada approves Skyrizi (risankizumab) for the treatment of moderate to severe plaque psoriasis
18 April 2019 - Approval of Skyrizi (risankizumab) is based on results from clinical studies showing significant improvement in levels of ...
Posted by Michael Wonder on 17 Apr 2019
Ultragenyx announces UX007 granted fast track designation and rare pediatric disease designation by U.S. FDA for treatment of long-chain fatty acid oxidation disorders
16 April 2019 - Company on track to submit NDA to FDA in mid 2019. ...
Posted by Michael Wonder on 17 Apr 2019
CRISPR Therapeutics and Vertex announce FDA fast track designation for CTX001 for the treatment of beta thalassemia
16 April 2019 - CRISPR Therapeutics and Vertex Pharmaceuticals Incorporated today announced that the U.S. FDA has granted fast track ...