Latest FDA News
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 28 November 2024
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Latest News & Features of interest to FDA
Pharmaceutical
The US medicines regulator has provided an update on its work to address the country’s ongoing opioid epidemic, leveraging new powers granted in 2018 under the SUPPORT Act. 25 October 2019
Pharmaceutical
The US Food and Drug Administration has said it will deactivate drug listings which contain obsolete or inaccurate information, after the agency identified a large number of older registrations which have not been adequately maintained. 14 August 2019
Pharmaceutical
The US Department of Health and Human Services (HHS) and the country’s Food and Drug Administration (FDA) have announced a plan to import certain prescription drugs in order to lower prices for patients. 31 July 2019
Pharmaceutical
Merck & Co is to participate in a US Food and Drug Administration (FDA) pilot program that uses blockchain technology to improve the way medicines are identified, tracked and traced within the USA. 13 June 2019
Biotechnology
The share price of Canadian biopharma Zymeworks (TSX: ZYME) closed 4% up on Wednesday after the company received two separate validations of its approach. 30 May 2019
Biosimilars
Ned Sharpless, Acting Commissioner of the US Food and Drug Administration, has issued a statement outlining final guidance aimed at helping bring interchangeable biosimilars to market. 13 May 2019
Generics
The US Food and Drug Administration (FDA) has released final guidance on the basis for generic drugmakers to determine whether to submit an Abbreviated New Drug Application (ANDA) or 505(b)(2) application for products. 13 May 2019
Pharmaceutical
A new report from industry analyst IQVIA has found that opioid prescriptions in the USA have declined 17% in the last year, the largest annual drop ever. 10 May 2019
Biotechnology
Merck & Co has picked up another approval in the USA for its anti-PD-1 therapy Keytruda (pembrolizumab), in combination with the TKI therapy Inlyta (axitinib), against advanced renal cell carcinoma (RCC). 23 April 2019
Biotechnology
The US Food and Drug Administration (FDA) has extended the review period for Daiichi Sankyo’s (TYO: 4568) quizartinib. 5 April 2019
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