11 February 2024 - Last summer, the FDA denied an application for a new anti-fungal drug called olorofim, sending it back ...
7 February 2024 - CDER’s Office of Generic Drugs and the EMA launched a voluntary pilot program to facilitate concurrent discussions ...
3 February 2024 - Of the 10 most common causes of death in the United States, 7 are chronic diseases: ...
29 September 2023 - Today, the US FDA is taking steps to help further accelerate the development of novel drug and ...
22 July 2023 - Gilead delayed a new version of a drug, allowing it to extend the patent life of a ...
6 July 2023 - Millions of Americans report that they are unable to fill their prescriptions or are not taking their ...
6 June 2023 - Agency requesting feedback on the draft recommendations and how they should be applied to increasingly diverse trial ...
20 March 2023 - The COVID-19 pandemic created a large, sudden unmet public health need for rapid access to safe and ...
23 February 2023 - Patients with rare diseases are experts in their health condition. They provide a unique perspective, and ...
10 January 2023 - Encouraging researchers and sponsors to simplify clinical trials and employ a fit for purpose protocol is ...
10 November 2022 - The use of generic drugs continues to increase, generating substantial savings for purchasers and improving affordable access ...
27 October 2022 - Increasing the availability of safe and effective medicines for children is a key priority for the US ...
17 October 2022 - This guidance provides recommendations to sponsors regarding considerations for tissue agnostic drug development in oncology. ...
6 October 2022 - For decades, academic clinical trials consortia have collaborated to optimise outcomes for childhood cancers through evaluating incremental ...
12 September 2022 - We reviewed US FDA initial approvals (2019-2021) of small molecules and antibody-drug conjugates for oncologic indications. ...