Blog
RSS FeedPosted by Michael Wonder on 25 Apr 2024
Bashing accelerated approval isn’t supported by the data
24 April 2024 - The FDA’s accelerated approval program aims to speed “approval of drugs that treat serious conditions, and ...
Posted by Michael Wonder on 23 Apr 2024
Associations between surrogate markers and clinical outcomes for non-oncologic chronic disease treatments
22 April 2024 - What is the strength of association between surrogate markers used as primary outcomes in clinical trials ...
Posted by Michael Wonder on 27 Mar 2024
Patient advocates clash over wisdom of ‘approving drugs faster and faster’
26 March 2024 - Over 30 years ago, Gregg Gonsalves and other AIDS activists persuaded Congress to create the accelerated ...
Posted by Michael Wonder on 28 Feb 2024
The FDA isn’t afraid to yank a disappointing drug
26 February 2024 - The FDA is rescinding its approval of a blood cancer treatment from the Swedish firm Oncopeptides, ...
Posted by Michael Wonder on 24 Feb 2024
FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)
23 February 2024 - Today, the FDA announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was ...
Posted by Michael Wonder on 21 Feb 2024
United Therapeutics starts litigation with FDA over rival Liquidia's drug application
21 February 2024 - United Therapeutics said on Wednesday it had filed a case with the US FDA, alleging that ...
Posted by Michael Wonder on 24 Jan 2024
FDA's ISTAND Pilot Program accepts submission of first artificial intelligence based and digital health technology for neuroscience
23 January 2024 - FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research recently accepted a ...
Posted by Michael Wonder on 24 Jan 2024
US FDA seeks 'boxed warning' for CAR-T cancer therapies
22 January 2024 - The US health regulator on Monday asked a host of drug makers, including Gilead Sciences, Johnson ...
Posted by Michael Wonder on 09 Jan 2024
Orphan drug label expansions: analysis of subsequent rare and common indication approvals
8 January 2024 - We found that 491 novel orphan drugs were approved between 1990 and 2022. ...
Posted by Michael Wonder on 08 Jan 2024
Novel drug approvals for 2023
8 January 2024 - Innovative drugs often mean new treatment options for patients and advances in health care for the American ...
Posted by Michael Wonder on 04 Jan 2024
2023 FDA approvals
2 January 2024 - The FDA’s Center for Drug Evaluation and Research approved 55 new drugs in 2023, as the small ...
Posted by Michael Wonder on 12 Dec 2023
FDA creates new advisory committee for evaluation of genetic metabolic disease treatments
12 December 2023 - Today, the US FDA announced it is creating a new advisory committee related to potential treatments for ...
Posted by Michael Wonder on 08 Dec 2023
Statement from President Joe Biden on FDA approval of gene therapies to treat sickle cell disease
8 December 2023 - As we’ve seen throughout our history, when the US Government invests in innovation, we can achieve breakthroughs ...
Posted by Michael Wonder on 07 Dec 2023
‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices
7 December 2023 - In 1997, Celgene obtained a key patent for what would become a blockbuster blood cancer treatment, ...
Posted by Michael Wonder on 20 Nov 2023
The FDA is at a crossroads on cell and gene therapies
20 November 2023 - Cell and gene therapies are the next frontier in medicine and promise long-sought hope for people ...