Blog
RSS FeedPosted by Michael Wonder on 25 Apr 2019
La Jolla Pharmaceutical announces U.S. FDA’s grant of breakthrough therapy designation for LJPC-0118 for the treatment of severe malaria
24 April 2019 - Designation offers potential for expedited development and review, and highlights the urgent need for additional treatment options ...
Posted by Michael Wonder on 25 Apr 2019
FDA hires Pew director to lead regulatory policy
24 April 2019 - Elizabeth Jungman, a well-known public health expert and a Capitol Hill veteran, will lead the FDA’s ...
Posted by Michael Wonder on 24 Apr 2019
AbbVie expands immunology portfolio in the U.S. with FDA approval of Skyrizi (risankizumab-rzaa) for moderate to severe plaque psoriasis
23 April 2019 - AbbVie today announced that the U.S. FDA approved Skyrizi (risankizumab-rzaa), an interleukin-23 inhibitor, for the treatment of ...
Posted 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 ...