Blog
RSS FeedPosted by Michael Wonder on 25 Apr 2020
Merck resubmits supplemental biologics license applications for Keytruda (pembrolizumab) six week dosing schedule
23 April 2020 - Additional applications filed across all approved adult indications. ...
Posted by Michael Wonder on 25 Apr 2020
FDA’s Woodcock on authorising the emergency use for hydroxychloroquine: ‘we did the best we could’
24 April 2020 - Over the past few weeks, the FDA has been criticised for some of the steps taken – ...
Posted by Michael Wonder on 25 Apr 2020
Maker of drug touted as coronavirus cure accuses China of gouging
24 April 2020 - Hydroxychloroquine controversially pushed by Trump as COVID-19 remedy. ...
Posted by Michael Wonder on 24 Apr 2020
FDA approves MenQuadfi, the latest innovation in meningococcal (MenACWY) vaccination
24 April 2020 - Latest innovation in quadrivalent meningococcal vaccination designed for use in persons 2 years of age and older ...
Posted by Michael Wonder on 24 Apr 2020
Drug makers prepare to make coronavirus treatments
23 April 2020 - Preparations would help make doses rapidly if testing pans out, but companies risk large outlays if the ...
Posted by Michael Wonder on 23 Apr 2020
Increasing access to FDA inspection reports on irregularities and misconduct in clinical trials
23 April 2020 - Transparency related to clinical trial protocols and data has become the expected standard over the past 2 ...
Posted by Michael Wonder on 23 Apr 2020
Drug maker tripled the price of a pill as it pursued coronavirus use
23 April 2020 - This month, Jaguar Health more than tripled the price of its lone FDA approved drug, right after ...
Posted by Michael Wonder on 23 Apr 2020
Bill Gates on how to fight future pandemics
23 April 2020 - The coronavirus will hasten three big medical breakthroughs. That is just a start. ...
Posted by Michael Wonder on 22 Apr 2020
Prediction models - development, evaluation and clinical application
23 April 2020 - When national lipid guidelines first incorporated a model based on data from the Framingham Heart Study — ...
Posted by Michael Wonder on 22 Apr 2020
Doctor says he was removed from federal post after opposing funding for unproven drugs
22 April 2020 - The former head of the federal office that will be at the forefront of developing a ...
Posted by Michael Wonder on 22 Apr 2020
New U.S. treatment guidelines for COVID-19 don’t see much progress
21 April 2020 - A panel of experts said there was insufficient evidence about many drugs that have been considered as ...
Posted by Michael Wonder on 22 Apr 2020
Mallinckrodt announces U.S. FDA filing acceptance of new drug application for terlipressin for treatment of hepatorenal syndrome type 1
22 April 2020 - Terlipressin would be the first FDA approved treatment option in the United States for adult patients with ...
Posted by Michael Wonder on 22 Apr 2020
FDA approves new therapy for triple negative breast cancer that has spread, not responded to other treatments
22 April 2020 - Today, the U.S. FDA granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients ...
Posted by Michael Wonder on 22 Apr 2020
Novartis Kymriah receives FDA regenerative medicine advanced therapy designation in follicular lymphoma
22 April 2020 - US regulatory filing for Kymriah in relapsed/refractory follicular lymphoma anticipated in 2021. ...
Posted by Michael Wonder on 22 Apr 2020
Wockhardt receives US FDA qualified infectious disease product designation for WCK 6777, a first ever once-a-day β-lactam enhancer class antibiotic
20 April 2020 - WCK 6777 is a once-a-day combination antibiotic based on Wockhardt’s NCE zidebactam, which imparts WCK 6777 ...