Blog
RSS FeedPosted by Michael Wonder on 04 Nov 2020
Salvia BioElectronics receives FDA breakthrough device designation for innovative neurostimulation solution
3 November 2020 - Salvia BioElectronics announced today that the U.S, FDA has granted breakthrough device designation for its implantable ...
Posted by Michael Wonder on 03 Nov 2020
Regulatory policy may not stop comparative efficacy trials
4 November 2020 - The way Sarfaraz K. Niazi, looks at it, doing comparative efficacy studies in humans to confirm that ...
Posted by Michael Wonder on 03 Nov 2020
FDA approves updated label for Endari
3 November 2020 - Emmaus Life Sciences announced today revised prescribing information for Endari to better inform healthcare professionals and sickle ...
Posted by Michael Wonder on 03 Nov 2020
Is it time for the FDA to be independent?
3 November 2020 - Public health experts and lay observers alike have expressed concerns that, under political pressure, the FDA ...
Posted by Michael Wonder on 03 Nov 2020
The FDA's cutoff for COVID-19 vaccine effectiveness is 50 percent. What does that mean?
3 November 2020 - Over the summer, the FDA announced that in order for an experimental COVID-19 vaccine to get ...
Posted by Michael Wonder on 03 Nov 2020
Food and Drug Administration accepts BioMarin's new drug application for vosoritide to treat children with achondroplasia
2 November 2020 - If approved, first therapy in U.S. for the treatment of achondroplasia. ...
Posted by Michael Wonder on 03 Nov 2020
Gilead faces pressure to relinquish valuable FDA voucher awarded with remdesivir approval
2 November 2020 - A prominent advocacy group is asking Gilead Sciences to relinquish a valuable voucher that came with ...
Posted by Michael Wonder on 03 Nov 2020
Provention Bio completes rolling submission of the biologics license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk individuals
2 November 2020 - Submission of chemistry, manufacturing and controls and administrative information modules represent completion of the Company's submission for ...
Posted by Michael Wonder on 02 Nov 2020
Janssen submits paliperidone palmitate 6 month supplemental new drug application to U.S. FDA for treatment of schizophrenia in adults
2 November 2020 - If approved, paliperidone palmitate 6 month will be the first and only long-acting injectable schizophrenia treatment with a ...
Posted by Michael Wonder on 02 Nov 2020
Takeda price hikes for a GI drug may give some patients another kind of stomachache
2 November 2020 - Two weeks ago, Takeda Pharmaceuticals raised the list price of its Entyvio treatment for ulcerative colitis ...
Posted by Michael Wonder on 01 Nov 2020
FDA approves Bronchitol for US market
2 November 2020 - Pharmaxis to manufacture product and export to USA. ...
Posted by Michael Wonder on 01 Nov 2020
The FDA’s Digital Health Center Of Excellence: why it matters and what it means to you
29 October 2020 - Last month, the US FDA launched the Digital Health Center of Excellence, bolstering the shift toward digital ...
Posted by Michael Wonder on 01 Nov 2020
A CDER study of factors that may predict the likelihood of generic drug marketing applications
28 October 2020 - The investigators compiled proprietary data related to abbreviated new drug applications and other internal or public ...
Posted by Michael Wonder on 31 Oct 2020
Gilead’s COVID-19 drug is mediocre. It will be a blockbuster anyway.
29 October 2020 - Gilead Sciences said Wednesday that remdesivir, which has been authorised for emergency use since the spring, brought ...
Posted by Michael Wonder on 31 Oct 2020
Social media disinformation campaigns tied to vaccine hesitancy
29 October 2020 - Social media disinformation campaigns designed to cast doubt on the safety and effectiveness of vaccines are contributing ...